1 |
NCI-2009-00817 |
4 |
-12.696568489074707 |
-2.5754833221435547 |
Human immunodeficiency virus (HIV) negative |
2 |
NCI-2011-00312 |
0 |
5.053690433502197 |
8.348408699035645 |
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive |
3 |
NCI-2011-00878 |
0 |
-9.185900688171387 |
6.779380798339844 |
Severe, active co-morbidity, defined as follows:
* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients
|
4 |
NCI-2011-01915 |
0 |
6.273831367492676 |
6.231972694396973 |
Patients known to be human immunodeficiency virus (HIV) positive and currently receiving retroviral therapy are not eligible; note: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for the study |
5 |
NCI-2011-01973 |
0 |
-8.485798835754395 |
2.009936571121216 |
Patients with known human immunodeficiency virus (HIV) positive must have a cluster of differentiation (CD)4 cell count be >= 350 cells/mm^3 within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol) |
6 |
NCI-2011-01974 |
0 |
-8.19375228881836 |
5.324880599975586 |
Severe, active co-morbidity, defined as follows:
* Acquired immune deficiency syndrome (AIDS) based upon the current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients |
7 |
NCI-2011-01987 |
4 |
8.986861228942871 |
3.2840301990509033 |
Patients with active human immunodeficiency virus (HIV) infection are eligible if their cluster of differentiation (CD)4 count is > 499/cu mm and their viral load is < 50 copies/ml; use of highly active antiretroviral treatment (HAART) is allowed |
8 |
NCI-2011-01992 |
4 |
-5.325077056884766 |
0.41472327709198 |
*B21Patients with known human immunodeficiency virus (HIV) infection are excluded
*No human immunodeficiency virus (HIV) infection; patients with immune dysfunction are at a significantly higher risk of toxicities from intensive immunosuppressive therapies |
9 |
NCI-2011-02034 |
0 |
0.39793887734413147 |
10.298637390136719 |
Patients with known human immunodeficiency virus (HIV) must have a CD4 count > 350 and be on concurrent antiretrovirals; patients with a history of intravenous drug abuse or any behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus; an HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk |
10 |
NCI-2011-02500 |
3 |
1.3555563688278198 |
-1.832167625427246 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; however, HIV-positive patients without an acquired immune deficiency syndrome (AIDS)-defining diagnosis who are not receiving agents with the potential for pharmacokinetic (PK) interactions with ABT-888 may be eligible |
11 |
NCI-2011-02515 |
4 |
-8.097931861877441 |
10.121696472167969 |
Patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to, active or uncontrolled infection, immune deficiencies, known human immunodeficiency virus (HIV) infection requiring antiretroviral therapy, |
12 |
NCI-2011-02539 |
0 |
6.573894023895264 |
-6.595823287963867 |
Known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible |
13 |
NCI-2011-02592 |
4 |
1.2944411039352417 |
1.2781273126602173 |
Patients must not have any known immune deficiencies; patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, known human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy are excluded from the study |
14 |
NCI-2011-02673 |
0 |
4.850718021392822 |
9.222810745239258 |
Patients must not be known to be human immunodeficiency virus (HIV)-positive |
15 |
NCI-2011-02674 |
1 |
-8.18733024597168 |
5.332120418548584 |
Severe, active co-morbidity, defined as follows:
* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients |
16 |
NCI-2012-00680 |
0 |
-7.111593246459961 |
3.097174882888794 |
PROCUREMENT: Patients with active human immunodeficiency virus (HIV) positive at time of procurement (can be pending at the time of blood draw) |
17 |
NCI-2012-00860 |
0 |
8.515836715698242 |
-3.0479395389556885 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy will be eligible unless the cluster of differentiation (CD)4 count is < 200 cells/mm^3 within one month of study enrollment |
18 |
NCI-2012-00864 |
4 |
4.281697750091553 |
9.762874603271484 |
Patients with a known active infection, e.g., hepatitis B virus or hepatitis C virus; human immunodeficiency virus (HIV)-positive patients who are otherwise well and who do not have evidence of significant immune compromise are eligible |
19 |
NCI-2012-01040 |
4 |
-11.062090873718262 |
3.8034613132476807 |
Human immunodeficiency virus (HIV)-positive patients who are not receiving: agents with the potential for PK interactions with romidepsin or hepatotoxic antiretrovirals (nucleoside reverse-transcriptase inhibitors [NRTIs]: abacavir, didanosine, emtricitabine, lamivudine, stavudine, and zidovudine), dual protease inhibitor (PI)-based regimens except low-dose boosting with ritonavir, atazanavir, indinavir, maraviroc, and nevirapine may be eligible; additionally, the HIV-positive patients should have a cluster of differentiation (CD)4 count > 250/mm^3; if the specific cause of hepatic dysfunction is unknown, the patient should be worked up for other viral causes of hepatitis and their eligibility determined after consultation with the principal investigator |
20 |
NCI-2012-01695 |
4 |
-13.862431526184082 |
8.194755554199219 |
All participants must be prescribed combination antiretroviral therapy with the goal of virological suppression using an acceptable regimen that adheres to national guidelines for treatment of HIV infection; non-suppressed, treatment experienced patients, defined as patients with a viral load > 400 copies/mL who have been on antiretroviral therapy for more than 4 months can be enrolled if an alternative antiretroviral therapy (ART) regimen is available that includes at least two ART drugs that, in the opinion of the site investigator, are expected to have activity based on genotypic testing (if available) and treatment history; patients are not allowed to receive zidovudine (azidothymidine [AZT]) as part of concurrent chemotherapy and ART regimen, since it is myelosuppressive; zidovudine may be discontinued and substituted as clinically indicated prior to or at the time of enrollment
*HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or confirmed by HIV-1 antigen or plasma HIV-1 ribonucleic acid (RNA) viral load > 1,000 copies/mL
* WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load |
21 |
NCI-2012-01712 |
4 |
4.3775129318237305 |
-0.7025667428970337 |
Exclusion:
HIV-positive patients on combination antiretroviral therapy which include cytochrome p450 inhibitors are ineligible; patients with CD4 counts less than 300 CD4+ cells/mm^3 and or a high viral load are ineligible
Inclusion:
Patients with human immunodeficiency virus (HIV) who are not receiving cytochrome p450 inhibitors, and who have a minimum of 300+ cluster of differentiation 4 (CD4)+ cells/mm^3, an undetectable viral load, and no history of acquired immune deficiency syndrome (AIDS) indicator conditions |
22 |
NCI-2012-01995 |
0 |
7.091732501983643 |
6.346423149108887 |
Patients known to be human immunodeficiency virus (HIV) positive may be enrolled if baseline cluster of differentiation (CD)4 count is > 500 cells/mm^3 AND not taking anti-retroviral therapy; patients with known hepatitis are not eligible unless there is a known negative hepatitis panel; (exception: previous history of hepatitis A infection that is not currently active is allowed); patients must not have any known uncontrolled underlying pulmonary disease |
23 |
NCI-2012-01998 |
3 |
5.468653202056885 |
4.544806480407715 |
Patients who are known to be human immunodeficiency virus positive (HIV+) are eligible providing they meet all of the following additional criteria within 28 days prior to registration:
* Cluster of differentiation (CD)4 cells >= 500/mm^3
* Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on combination antiretroviral therapy (cART) or < 25,000 copies HIV mRNA if not on cART
* No zidovudine or stavudine as part of cART
* Patients who are HIV+ and do not meet all of these criteria are not eligible for this study |
24 |
NCI-2012-02009 |
0 |
8.018193244934082 |
-4.863396167755127 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are not eligible |
25 |
NCI-2012-02057 |
0 |
11.505751609802246 |
-6.773062229156494 |
Use of combination anti-retroviral therapy for human immunodeficiency virus (HIV) |
26 |
NCI-2012-02608 |
0 |
-10.859307289123535 |
2.3616995811462402 |
STEP I: Human immunodeficiency virus (HIV) infection is not excluded; known HIV positive patients must meet the following criteria:
* Cluster of differentiation (CD)4 cell count >= 350/mm^3
* No history of acquired immune deficiency syndrome (AIDS)-related illness
* Not currently prescribed zidovudine or stavudine |
27 |
NCI-2012-02767 |
0 |
5.9202351570129395 |
6.774339199066162 |
Immunocompromised patients (other than that related to the use of corticosteroids) with the exception of patients known to be human immunodeficiency virus (HIV) positive and have a cluster of differentiation 4 (CD4) count > 400 and do not require antiretroviral therapy |
28 |
NCI-2012-02875 |
0 |
-13.654579162597656 |
-1.390559196472168 |
Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) |
29 |
NCI-2012-03124 |
0 |
7.986170291900635 |
-7.12912130355835 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible |
30 |
NCI-2013-00046 |
4 |
0.3059844970703125 |
-4.507761478424072 |
Participants must have previously untreated HIV-classical HL (cHL), with the exception of up to 14 consecutive days of steroids, emergency radiation, or 1 prior cycle of cyclophosphamide to reduce tumor burden and improve hyperbilirubinemia in the setting of lymphoma related liver involvement
Participants must discontinue use of the following agents within 7 days prior to therapy
* Strong CYP3A4 inhibitors that treat HIV
* If patients are taking any of these excluded medications, they must be discontinued at least 7 days (1 week) prior to the initiation of chemotherapy
HIV positive; documentation of HIV-1 infection by means of any one of the following:
* Documentation of HIV diagnosis in the medical record by a licensed health care provider;
* Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider;
* HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL;
* Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 western blot confirmation or HIV rapid multispot antibody differentiation assay
Patients already receiving erythropoietin or granulocyte colony stimulating factor (GCSF) for treatment of HIV-related cytopenia are eligible
* NOTE: A ââ¬Ålicensedââ¬Â assay refers to a United States (US) Food and Drug Administration (FDA)-approved assay, which is required for all investigational new drug (IND) studies
Patients already receiving erythropoietin or granulocyte colony stimulating factor (GCSF) for treatment of HIV-related cytopenia are eligible |
31 |
NCI-2013-00370 |
0 |
-9.268887519836426 |
6.069780349731445 |
Severe, active co-morbidity, defined as follows:
* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
|
32 |
NCI-2013-00500 |
0 |
-8.19728946685791 |
5.321386814117432 |
Severe, active co-morbidity, defined as follows:
* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease and Control and Prevention (CDC) definition; note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients |
33 |
NCI-2013-00716 |
0 |
-0.331832617521286 |
3.3984873294830322 |
Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to: active or uncontrolled infection, immune deficiencies or confirmed diagnosis of human immunodeficiency virus (HIV) infection, ... that would limit compliance with study requirements |
34 |
NCI-2013-00737 |
0 |
-8.190654754638672 |
5.3279876708984375 |
Severe, active co-morbidity, defined as follows:
* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients |
35 |
NCI-2013-00739 |
0 |
-2.735102653503418 |
2.9676923751831055 |
Patients with known chronic human immunodeficiency virus (HIV), hepatitis B or hepatitis C infections should be excluded |
36 |
NCI-2013-00740 |
0 |
-14.46054458618164 |
3.684521198272705 |
Inclusion:
*Participants must have known HIV infection and histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; any number of prior cancer therapies will be permitted; at least 4 weeks must have elapsed since prior chemotherapy or biological therapy, 6 weeks if the regimen included carmustine (BCNU) or mitomycin C; prior radiation therapy to the thoracic cavity, abdomen, or pelvis must be completed at least 3 months prior to registration; radiotherapy to any other site (including bone or brain metastases) must be completed at least 28 days prior to registration
*Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive western blot, or any other federally approved licensed HIV test; alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and western blot, or other approved diagnostic tests
* Participating participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications, when clinically indicated and should be under the care of a physician experienced in HIV management; participants will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 8 weeks following study entry; as study-specific (antiretroviral-based) strata fill, however, only participants who are receiving the therapies eligible for the remaining open strata will be accrued
Exclusion:
Other clinically significant disorders such as:
* Active infection requiring systemic treatment within 28 days before the first dose of study treatment; participants with HIV infection will be eligible provided they meet the criteria; |
37 |
NCI-2013-00826 |
3 |
-11.966628074645996 |
1.8234076499938965 |
Human immunodeficiency virus (HIV)-positive patients will be eligible unless they have been previously diagnosed with an acquired immune deficiency syndrome (AIDS)-defining illness |
38 |
NCI-2013-00858 |
0 |
9.483072280883789 |
-5.087620735168457 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible |
39 |
NCI-2013-00877 |
0 |
8.689827919006348 |
-6.036988258361816 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible |
40 |
NCI-2013-00890 |
4 |
6.4908647537231445 |
-5.5949201583862305 |
Known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible |
41 |
NCI-2013-00998 |
0 |
3.926807165145874 |
-2.4442086219787598 |
Known human immunodeficiency virus (HIV) or other history of immunodeficiency disorder; HIV-positive patients on combination antiretroviral therapy are ineligible |
42 |
NCI-2013-01132 |
3 |
-0.03362293168902397 |
3.2398648262023926 |
Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to active or uncontrolled infection, immune deficiencies, known human immunodeficiency virus (HIV) infection requiring protease inhibitor therapy, ... that would limit compliance with study requirements |
43 |
NCI-2013-01275 |
4 |
-6.826302528381348 |
-0.8821879029273987 |
PHASE I: Human immunodeficiency virus (HIV) positive patients are allowed on this study if they have a cluster of differentiation 4 (CD4) count > 400, and are on a stable antiviral regimen; patients with poorly controlled HIV or other chronic active viral infections will be excluded
PHASE II: HIV positive patients are allowed on this study if they have a CD4 count > 400, and are on a stable antiviral regimen; patients with poorly controlled HIV or other chronic active viral infections will be excluded |
44 |
NCI-2013-01320 |
3 |
-8.78115463256836 |
1.1372405290603638 |
Patients with human immunodeficiency virus (HIV) are eligible if they are not on antiviral agents and have adequate cluster of differentiation (CD)4 counts (>= 500 mm^3) |
45 |
NCI-2013-01357 |
0 |
-1.0195063352584839 |
1.8546923398971558 |
Known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible); patients with human immunodeficiency virus (HIV) are not eligible if on anti-retroviral medications
HIV-positive patients on combination antiretroviral therapy are ineligible |
46 |
NCI-2013-01368 |
0 |
5.682053565979004 |
5.079203128814697 |
Patients who are known to be human immunodeficiency virus positive (HIV+) are eligible providing they meet all of the following additional criteria within 28 days prior to registration:
* CD4+ cells >= 350/mm^3 (nadir)
* Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on combination antiretroviral therapy (cART) or < 25,000 copies HIV mRNA if not on cART
* No zidovudine or stavudine as part of cART
Patients who are HIV+ and do not meet all of these criteria are not eligible for this study |
47 |
NCI-2013-01452 |
0 |
9.03615665435791 |
-6.97554349899292 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible |
48 |
NCI-2013-01474 |
0 |
4.741064548492432 |
-3.1414988040924072 |
Human immunodeficiency virus (HIV) positive patients who are not on retroviral therapy will not be excluded from cohort 1, the normal liver function cohort
* HIV positive patients who are not on retroviral therapy will be excluded from cohorts 2-4
HIV-positive patients on combination antiretroviral therapy are ineligible |
49 |
NCI-2013-01491 |
4 |
-3.2974812984466553 |
3.955993890762329 |
Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV) will be excluded; patients with HIV who have adequate cluster of differentiation (CD)4 count, not requiring antiretroviral medication will not be excluded |
50 |
NCI-2013-01496 |
0 |
8.74269962310791 |
-6.580472469329834 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible |
51 |
NCI-2013-01520 |
0 |
-1.8896994590759277 |
4.455079078674316 |
Documented human immunodeficiency virus (HIV), active bacterial infections, active or chronic hepatitis B, or hepatitis C infection |
52 |
NCI-2013-01568 |
0 |
9.805012702941895 |
-4.2158522605896 |
Human immunodeficiency virus (HIV) positive patients on antiretroviral therapy are ineligible |
53 |
NCI-2013-01588 |
0 |
1.0953807830810547 |
-3.822650909423828 |
TUMOR BIOPSY SEQUENCING: Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
TREATMENT: HIV-positive patients on combination antiretroviral therapy are ineligible |
54 |
NCI-2013-01702 |
4 |
4.627441883087158 |
2.5630247592926025 |
Patients with human immunodeficiency virus (HIV) infection are eligible, provided they meet the following:
* No history of acquired immunodeficiency syndrome (AIDS)-defining conditions or other HIV related illness
* Cluster of differentiation (CD)4+ cells nadirs > 350/mm^3
* Treatment sensitive HIV and, if on anti-HIV therapy, HIV viral load < 50 copies/mm^3
* Please note: HIV+ patients who enroll on this study and are assigned to treatment with ixazomib may need to modify their anti-retroviral therapy prior to receiving protocol therapy if they are on strong inducers or potent inhibitors of cytochrome P450 3A4 |
55 |
NCI-2013-01703 |
0 |
9.505545616149902 |
-6.715939044952393 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible |
56 |
NCI-2013-01748 |
0 |
-8.873774528503418 |
1.177151083946228 |
Human immunodeficiency virus (HIV)-positive patients on antiviral drugs and/or cluster of differentiation (CD)4 count is inadequate (< 500); if neither condition exists, HIV-positive patients are eligible |
57 |
NCI-2013-01850 |
4 |
-8.867142677307129 |
6.039931297302246 |
Severe, active co-morbidity, defined as follows:
* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol |
58 |
NCI-2013-01999 |
0 |
-12.960973739624023 |
-1.4518826007843018 |
Human immunodeficiency virus (HIV)-positive patients |
59 |
NCI-2013-02103 |
0 |
9.803853988647461 |
-5.424185276031494 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible |
60 |
NCI-2013-02167 |
0 |
-6.987486839294434 |
0.8348279595375061 |
Patients that are known to be positive for human immunodeficiency virus (HIV) are not eligible; note: inclusion of HIV positive patients will be considered at a later date |
61 |
NCI-2013-02229 |
0 |
-4.55076265335083 |
-3.431593418121338 |
Patients with known human immunodeficiency virus (HIV) infection are eligible if they meet all of the following criteria:
* No history of acquired immune deficiency syndrome (AIDS)-related complications other than a history of low CD4+ T-cell count (< 200/mm^3) prior to initiation of combination antiretroviral therapy; on study CD4+ T-cell count may not be informative due to leukemia and should not be used as an exclusion criterion if low
* Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the leukemia
* Patient must have serum HIV viral load of < 200 copies/mm^3
* Patient must be on combination antiretroviral therapy with minimal pharmacokinetic interactions with study therapy and minimal overlapping clinical toxicity with protocol therapy
* Patient must not be receiving protease inhibitors or once daily formulations containing cobicistat, stavudine, or zidovudine.
* It is recommended to utilize a regimen of the integrase inhibitor, dolutegravir, combined with either disoproxil fumarate/emtricitabine or dolutegravir combined with tenofovir alafenamide/emtricitabine |
62 |
NCI-2013-02238 |
0 |
-2.7315969467163086 |
2.9660985469818115 |
Patients with chronic human immunodeficiency virus (HIV), hepatitis B or hepatitis C infections should be excluded |
63 |
NCI-2013-02288 |
3 |
-1.5920751094818115 |
-5.491657257080078 |
EXCLUSION
Participants who received investigational agents, other than investigational antiretroviral agents for HIV, within the 4 weeks before randomization, unless approved by the study chair
Inclusion:
HIV-positive; documentation of HIV-1 infection by means of any one of the following:
* Documentation of HIV diagnosis in the medical record by a licensed health care provider
* Documentation of receipt of antiretroviral therapy (ART) (at least two different medications) by a licensed health care provider (documentation may be a record of an ART prescription in the participantââ¬â¢s medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participantââ¬â¢s name)
* HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL
* Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay
Cluster of differentiation (CD)4 count >= 200 within 120 days prior to enrollment or plasma HIV-1 RNA < 200 copies/mL within 120 days prior to randomization
|
64 |
NCI-2013-02426 |
0 |
2.896244525909424 |
-3.500131368637085 |
Known human immunodeficiency virus (HIV) infected patients (HIV testing will not be performed as a part of screening) on combination antiretroviral therapy are eligible for inclusion; the use of zidovudine is not allowed |
65 |
NCI-2014-00115 |
4 |
-9.819293975830078 |
-2.448686361312866 |
Patients unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the day 1 vaccination: (a) children =< 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczematoid skin disorders, or (d) immunocompromised individuals, such as those with human immunodeficiency virus (HIV) |
66 |
NCI-2014-00416 |
1 |
3.8453643321990967 |
-3.845745325088501 |
Patients with known human immunodeficiency virus (HIV) infection are eligible if not on antiviral agents and cluster of differentiation (CD)4 counts are adequate (>= 500)
HIV-positive patients on combination antiretroviral therapy are ineligible |
67 |
NCI-2014-00461 |
4 |
-2.3477628231048584 |
2.5383481979370117 |
Known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible); patients with human immunodeficiency virus (HIV) are not eligible if on anti-retroviral medications |
68 |
NCI-2014-00615 |
4 |
6.306541442871094 |
6.208544731140137 |
Patients known to be human immunodeficiency virus (HIV)-positive patients and on combination antiretroviral therapy are ineligible |
69 |
NCI-2014-00620 |
0 |
9.076802253723145 |
-4.777502536773682 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible |
70 |
NCI-2014-00627 |
0 |
-0.6353609561920166 |
9.746784210205078 |
Patients with a known history of human immunodeficiency virus (HIV) seropositivity:
* Must have undetectable viral load using standard HIV assays in clinical practice
* Must have cluster of differentiation (CD)4 count >= 400/mcL
* Must not require prophylaxis for any opportunistic infections (i.e., fungal, Mycobacterium avium complex [mAC], or pneumocystis jiroveci pneumonia [PCP] prophylaxis)
* Must not be newly diagnosed within 12 months prior to sub-study registration |
71 |
NCI-2014-00629 |
4 |
-7.626514911651611 |
-0.25311416387557983 |
patients with human immunodeficiency virus (HIV) are not eligible if on anti-retroviral medications |
72 |
NCI-2014-00631 |
0 |
-6.631689071655273 |
-2.149610996246338 |
Patients with known human immunodeficiency virus (HIV) infection |
73 |
NCI-2014-00634 |
0 |
-12.369169235229492 |
2.1035215854644775 |
Human immunodeficiency virus (HIV)-positive patients on strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors are ineligible |
74 |
NCI-2014-00635 |
0 |
-8.873178482055664 |
6.032334804534912 |
Severe, active co-morbidity, defined as follows:
* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol |
75 |
NCI-2014-00636 |
0 |
-1.5624181032180786 |
-5.485187530517578 |
HIV positive; documentation of HIV-1 infection by means of any one of the following:
* Documentation of HIV diagnosis in the medical record by a licensed health care provider;
* Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider (documentation may be a record of an ART prescription in the participantââ¬â¢s medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participantââ¬â¢s name; receipt of at least two agents is required; each component agent of a multi-class combination ART regimen will be counted toward the 2-agent requirement, excepting receipt of a pre-exposure prophylaxis [PrEP] regimen alone [e.g., Truvada], which is exclusionary);
* HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL;
* Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 western blot confirmation or HIV rapid multispot antibody differentiation assay
* NOTE: A ââ¬Ålicensedââ¬Â assay refers to a United States (US) Food and Drug Administration (FDA)-approved assay, which is required for all investigational new drug (IND) studies |
76 |
NCI-2014-00643 |
4 |
-1.76029372215271 |
4.4517035484313965 |
Patients must not have known human immunodeficiency virus (HIV) infection or active hepatitis B or C infections |
77 |
NCI-2014-00644 |
0 |
6.286388874053955 |
7.004376411437988 |
Patients known to be human immunodeficiency virus (HIV) positive with one or more of the following:
* Baseline cluster of differentiation (CD)4 count of < 250 cells/mm^3
* History of acquired immune deficiency syndrome (AIDS) indicator conditions
* Anti-retroviral therapy with any potent CYP3A4 inhibitor |
78 |
NCI-2014-00686 |
0 |
-8.793679237365723 |
9.124261856079102 |
Although they will not be considered formal eligibility (exclusion) criteria, physicians should recognize that the following may seriously increase the risk to the patient entering this protocol:
* Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
|
79 |
NCI-2014-00688 |
0 |
9.160207748413086 |
-6.171656608581543 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible |
80 |
NCI-2014-00702 |
3 |
8.7302885055542 |
1.9706971645355225 |
Severe, active co-morbidity, defined as follows:
* Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD) 4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
|
81 |
NCI-2014-00746 |
0 |
-12.258466720581055 |
-0.6456365585327148 |
Known human immunodeficiency virus (HIV)-positive patients should have a cluster of differentiation (CD)4 count > 250/mm^3 |
82 |
NCI-2014-00816 |
3 |
9.9025239944458 |
-5.897880554199219 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible |
83 |
NCI-2014-00849 |
4 |
8.730401992797852 |
1.97068452835083 |
Severe, active co-morbidity, defined as follows:
* Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
|
84 |
NCI-2014-00907 |
1 |
8.527832984924316 |
-7.161431789398193 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible |
85 |
NCI-2014-01043 |
1 |
9.9932279586792 |
-2.8000762462615967 |
Human immunodeficiency virus (HIV)-positive patients on highly active antiretroviral therapy (HAART) are excluded |
86 |
NCI-2014-01047 |
0 |
7.502491474151611 |
0.8589096665382385 |
Patients known to be positive for HIV (the human immunodeficiency virus) may be eligible, providing they meet the following additional criteria within 28 days prior to registration:
* No history of acquired immune deficiency syndrome (AIDS)-defining conditions
* CD4 cells > 350 cells/mm^3
* If on antiretroviral agents, must not include zidovudine or stavudine
* Viral load =< 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on combination antiretroviral therapy (cART) or =< 25,000 copies HIV mRNA/mm^3 if not on cART
* Highly active antiretroviral therapy (HAART) regimens are acceptable providing they have only weak P450A4 interactions |
87 |
NCI-2014-01072 |
0 |
-9.268887519836426 |
6.069780349731445 |
Severe, active co-morbidity, defined as follows:
* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
|
88 |
NCI-2014-01106 |
0 |
-1.0192553997039795 |
1.8539655208587646 |
Known human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection, which will be allowed); patients with human immunodeficiency virus (HIV) are not eligible if on anti-retroviral medications
HIV-positive patients on combination antiretroviral therapy are ineligible |
89 |
NCI-2014-01107 |
0 |
-9.289804458618164 |
0.6497508883476257 |
Patients with human immunodeficiency virus (HIV) will not be denied an opportunity to participate in this clinical trial, if they have adequate cluster of differentiation (CD)4 counts (> 250 CD4+ T lymphocytes/uL) and would be able to be maintained on an antiretroviral combination without pronounced effects on cytochrome (CYP)3A4, 2C9, or 2C19 |
90 |
NCI-2014-01118 |
0 |
8.700074195861816 |
-9.487115859985352 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; if an HIV-positive patient has adequate cluster of differentiation (CD4) counts (CD4 above the lower limit of institutional normal) and is on antiretroviral therapy with newer agents, which are not strong cytochrome (CYP) inhibitors, they will be eligible |
91 |
NCI-2014-01222 |
0 |
-9.168031692504883 |
-1.5619994401931763 |
Patients with known human immunodeficiency virus (HIV) or hepatitis B or C are excluded |
92 |
NCI-2014-01223 |
0 |
-7.006388187408447 |
0.7472519874572754 |
Patients known to be positive for human immunodeficiency virus (HIV) are not eligible |
93 |
NCI-2014-01340 |
0 |
11.457839012145996 |
-4.876531600952148 |
Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible |
94 |
NCI-2014-01470 |
0 |
5.085649013519287 |
3.4651057720184326 |
Patients with known human immunodeficiency virus (HIV) may be eligible providing they meet the following additional criteria:
* Cluster of differentiation (CD)4 cells >= 500/uL
* Serum HIV viral load of < 25,000 IU/ml
* No current antiretroviral therapy
** Tests must be obtained within 28 days prior to registration; patients who are HIV positive (+) and do not meet all of these criteria are not eligible for this study (HIV/hepatitis testing are not required for patients without known infection) |
95 |
NCI-2014-01696 |
0 |
-13.841974258422852 |
8.078914642333984 |
Negative serology (antibody test) for the following infectious diseases:
* Human immunodeficiency virus (HIV) type 1 and 2
* Human T-cell leukemia virus (HTLV) type 1 and 2 (mandatory in United States [US] but optional in Canada and Europe)
* Hepatitis B surface antigen
* Hepatitis C antibody |
96 |
NCI-2014-01747 |
0 |
4.843106269836426 |
9.915264129638672 |
Individuals who are known to be human immunodeficiency virus (HIV) infected are eligible (note: HIV testing is not required for entry into the study) |
97 |
NCI-2014-01754 |
0 |
-6.273995876312256 |
1.681368112564087 |
Human immunodeficiency virus (HIV) positive patients will be excluded with the exception of patients without CD4 depletion (i.e. above the institutional lower limit of normal) and who have no other acquired immune deficiency syndrome (AIDS)-related complications and who have Epstein-Barr virus (EBV) negative tumors; the number of patients in this category is expected to be very low and the principal investigator (PI) will decide their eligibility on a case by case basis |
98 |
NCI-2014-01810 |
4 |
8.0680513381958 |
2.3602418899536133 |
Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol |
99 |
NCI-2014-01927 |
0 |
7.557531833648682 |
-4.917511463165283 |
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible |
100 |
NCI-2014-01984 |
0 |
5.45720100402832 |
9.190558433532715 |
Patients who are human immunodeficiency virus (HIV) positive may participate if they meet the following eligibility requirements:
* They must be stable on their anti-retroviral regimen, and they must be healthy from an HIV perspective
* They must have a cluster of differentiation (CD)4 count of greater than 250 cells/mcL
* They must not be receiving prophylactic therapy for an opportunistic infection |