Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study of Two Long-Acting Broadly Neutralizing Antibodies with ART Initiation in Adults Living with HIV-1 in Sub-Saharan Africa
Led by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Updated on 2025-01-31
135
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two new laboratory-made antibodies, 10-1074-LS and 3BNC117-LS, for adults living with HIV-1 in Sub-Saharan Africa. These antibodies are designed to attach to HIV and block it from infecting cells and spreading. The study aims to see if these antibodies affect the amount of HIV that remains in blood cells while on antiretroviral therapy (ART) and after stopping ART, as well as to assess their safety and any side effects. Participants will be randomly assigned to receive either the two antibodies or placebo infusions combined with ART at the start of the study. The antibodies and placebos are given intravenously on the first day of the initial treatment period. The study includes multiple steps, including starting ART with antibody or placebo infusions, stopping ART under close monitoring, and following participants to observe the return of the virus and any need to restart ART. During the study, participants will attend scheduled visits for blood tests to measure HIV levels, immune cell counts, and safety labs. Researchers will track side effects and monitor how long it takes for the virus to rebound after stopping ART. Participants will also be asked to use contraception methods if of child-bearing potential and follow precautions to prevent HIV transmission during treatment interruption. The study duration includes at least 56 weeks of safety and efficacy monitoring after infusion and follow-up for up to 72 weeks after ART discontinuation.
CONDITIONS
Brief Title
Antiretrovirals Combined With Antibodies for HIV-1 Cure In Africa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 60 years
- Confirmed HIV-1 infection by approved tests before study entry
- ART-naïve participants (no prior antiretroviral therapy)
- CD4+ T cell count greater than 200 cells/mm3 within 28 days before entry
- Plasma HIV-1 RNA greater than 1000 copies/mL within 28 days before entry
- Negative pregnancy test within 72 hours before entry for those of child-bearing potential
- Agreement to use two forms of contraception if sexually active and able to become pregnant
- Willingness to start ART at enrollment and participate in scheduled study visits
- Ability to provide informed consent
You will not qualify if you...
- Any significant acute or chronic medical condition other than HIV that may affect safety or study results
- Recent or active non-HIV cancer requiring treatment within past 36 months
- History of AIDS-defining illness within 3 years prior to enrollment
- Recent use of systemic corticosteroids, immunosuppressive drugs, chemotherapy, or similar therapies within past 12 weeks
- History of severe allergic reactions such as anaphylaxis within 2 years prior to enrollment
- Known active Hepatitis B or C infection unless cured
- History or current clinical atherosclerotic cardiovascular disease
- Previous receipt of HIV vaccine or monoclonal antibody therapy
- Participation in another investigational study within 28 days before entry
- Active drug or alcohol use that may interfere with study adherence
- Breastfeeding
- Certain laboratory abnormalities including low blood counts or impaired kidney or liver function
- Use of prohibited medications with ART within 7 days before entry
- Viral failure or ART interruption during initial study steps
- Current ART regimen including long-acting or NNRTI components
- Intercurrent illnesses increasing risk during treatment interruption
- Transfer to other cohort studies during later study steps
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 weeks, 72 weeks, or 84 weeks depending on individual pharmacokinetic modeling
Participants start antiretroviral therapy (ART) and receive infusions of either broadly neutralizing antibodies or placebo.
Multiple visits throughout treatment period for infusions and monitoring
Duration - Up to 72 weeks after ART discontinuation
Participants are monitored after discontinuation of ART to assess viral rebound and possible ART restart.
Regular visits during follow-up period to assess HIV-1 RNA levels and health status
Trial Site Locations
Total: 4 locations
1
Gaborone CRS (12701)
Gaborone, Botswana
Actively Recruiting
2
University of the Witwatersrand Helen Joseph (WITS HJH) CRS (11101)
Johannesburg, Gauteng, South Africa, 2193
Actively Recruiting
3
CAPRISA eThekwini CRS (31422)
Durban, KwaZulu-Natal, South Africa, 4011
Actively Recruiting
4
Durban Adult HIV CRS (11201)
Durban, South Africa, 4013 SF
Actively Recruiting
Research Team
A
ACTG CT.gov Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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