NCT06205602

Antiretrovirals Combined With Antibodies for HIV-1 Cure In Africa

A Randomized, Double-Blind, Placebo-Controlled Study of the Combination of Two Long-Acting Broadly Neutralizing Antibodies at ART Initiation in Adults Living With HIV-1 in Sub-Saharan Africa: The ACACIA Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	3BNC117-LS	30 mg/kg to be administered via IV at Step 1 (Day 1)
DRUG	10-1074-LS	10 mg/kg to be administered intravenously at Step 1 (Day 1)
DRUG	Placebo for 3BNC117-LS	0.9% Sodium Chloride Injection to be administered intravenously at Step 1 (Day 1)
DRUG	Placebo for 10-1074-LS	0.9% Sodium Chloride Injection) to be administered IV at Step 1 (Day 1)

Timeline

• Start date: 2025-01-17
• Primary completion: 2029-02-16
• Completion: 2029-02-16
• First posted: 2024-01-16
• Last updated: 2025-01-31

Locations

4 sites across 2 countries: Botswana, South Africa

Regulatory

• FDA-regulated drug study