The effect of anti-latency reversing therapy and broadly neutralizing antibodies on the HIV-1 reservoir in patients on antiretroviral therapy - a randomized trial (ROADMAP)
- Conditions
- HIV infectionMedDRA version: 20.0Level: LLTClassification code 10020180Term: HIV positiveSystem Organ Class: 100000004848MedDRA version: 20.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-005238-23-DK
- Lead Sponsor
- Rockefeller University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
1) Adults age 18-65 years with documented HIV-1 infection
2) CD4+ T-cell count >500 cells/mm3 at screening
3) On ART for a minimum of 18 months and HIV-1 RNA plasma level of < 50 copies/ml by standard assays for at least 12 months (a single viral load measurement > 50 but < 500 copies/ml during this time period is allowable).
4) Individuals on protease inhibitor or NNRTI-based regimens must be willing to switch to an integrase-inhibitor-based regimen (raltegravir or dolutegravir) prior to enrollment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) Use of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the investigators within the last 6 months
2) Pregnancy as determined by a positive urine beta-hCG.
3) Participant unwilling to use two reliable contraception methods (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting IUD, hormone-based contraceptive with condom) for the study duration.
4) Currently breast-feeding.
5) History of resistance to 2 or more classes of antiretroviral medication
6) Any medical, psychiatric, social, or occupational condition that, as judged by the investigators, would interfere with the evaluation of study objectives (such as severe alcohol or drug abuse, dementia).
7) Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood.
8) Receipt of an HDAC inhibitor or 3BNC117 in the past 2 years.
9) Have a history of AIDS-defining illness within 3 years prior to enrollment.
10) History of significant coronary artery disease, myocardial infarction, percutaneous coronary intervention with placement of cardiac stents.
11) ECG at screening that shows QTc >450 msec when calculated using the Fridericia formula from either lead V3 or V4.
12) Use of Coumadin or Coumadin derivatives
13) Laboratory abnormalities in the parameters listed below:
13a) Absolute neutrophil count = 1,300
13b) Hemoglobin = 10 gm/dL
13c) Platelet count = 125,000
13d) ALT = 2.0 x ULN
13e) AST = 2.0 x ULN
13f) Total bilirubin = 2.0 x ULN (for participants on atazanavir, a total bilirubin up to 3 x ULN is allowable)
13g) eGFR < 60 mL/min/1.73m2
14) Any vaccination within 14 days prior to 3BNC117 administration
15) Receipt of any therapeutic HIV vaccine in the past
16) Receipt of any monoclonal antibody therapy of any kind in the past 2 years
17) Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method