Actively Recruiting
Antiretrovirals Combined With Antibodies for HIV-1 Cure In Africa
Led by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Updated on 2025-01-31
135
Participants Needed
4
Research Sites
213 weeks
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
For people living with HIV, antiretroviral therapy (ART) helps to stop the virus from multiplying. The goal of current HIV treatment is to have such a small amount of the virus in the blood that it does not show up on regular tests. HIV is also hidden in cells throughout the body and can start multiplying when ART is stopped. This research study will test two new study drugs: 10-1074-LS and 3BNC117-LS. Both of these study drugs are antibodies against HIV. An antibody is generally a substance that the body makes in response to an infection. The antibodies being used in this study were made in a laboratory and were designed to attach to HIV and can block HIV from attacking cells in the body and from spreading to other parts of the body. These antibodies are being developed to potentially treat and prevent HIV. The main purpose of this study is to see if the study drugs affect the level of HIV that remains in the blood cells while taking ART and the level of HIV in the blood after discontinuing taking ART. The study will also see if it is safe to give people these antibodies and if they cause any side effects.
CONDITIONS
Official Title
Antiretrovirals Combined With Antibodies for HIV-1 Cure In Africa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed HIV-1 infection documented by licensed tests prior to study entry
- ART-nafve (prior use of PrEP or PEP allowed except long-acting ARVs within last 24 months)
- CD4+ T cell count above 200 cells/mm3 within 28 days before study entry
- Plasma HIV-1 RNA greater than 1000 copies/mL within 28 days before study entry
- Negative pregnancy test within 72 hours before entry for persons of child-bearing potential
- Willingness to use two forms of contraception during Step 1 if of child-bearing potential
- Agreement to use barrier protection or abstinence to prevent HIV transmission during study
- Ability and willingness to start ART at enrollment and participate in scheduled study visits
- Negative hepatitis B surface antigen and hepatitis C tests within 16 weeks prior to Step 2
- Receipt of study antibodies or placebo in Step 1
- HIV-1 RNA less than 200 copies/mL and CD4+ T cell count at least 450 cells/mm3 within 6 weeks before Step 2
- Negative pregnancy test within 48 hours before Step 2 for persons of child-bearing potential
- Ability and willingness to stop ART at Step 2
- Completion of Step 2 and willingness to continue analytic treatment interruption (ATI) in Step 3
- Met ART restart criteria or completed Step 3 for Step 4 eligibility
You will not qualify if you...
- Any significant acute or chronic medical condition other than HIV affecting safety or study results
- Recent or active non-HIV malignancy requiring systemic treatment in past 36 months
- History of AIDS-defining illness within 3 years prior to enrollment
- Recent use of systemic corticosteroids or immunosuppressive therapies within 12 weeks
- History of severe allergic reactions or chronic urticaria requiring daily treatment
- Active Hepatitis B or Hepatitis C infection (except cured HCV)
- History of or current atherosclerotic cardiovascular disease
- Prior receipt of HIV vaccine or monoclonal antibody therapy
- Participation in other investigational drug studies within 28 days prior to entry
- Active drug or alcohol use interfering with study adherence
- Breastfeeding
- Specific laboratory abnormalities including low neutrophils, hemoglobin, platelets, elevated liver enzymes, bilirubin, or reduced kidney function
- Use or planned use of prohibited medications with ART within 7 days before or during study
- Viral failure after Step 1 week 24 or not starting ART
- Use of ART regimens including long-acting or NNRTI components
- Medical conditions or illnesses increasing risk during analytic treatment interruption
- Transfer to another study cohort (Step 3 exclusion)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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