RecruitingPhase 2NCT06205602

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

Sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Enrollment

135 participants

Start Date

Jan 17, 2025

Study Type

INTERVENTIONAL

Conditions

HIV-1-infection

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two laboratory-made antibodies (10-1074-LS and 3BNC117-LS) in people living with HIV in Africa to see if they can reduce the amount of HIV hiding in the body while on antiretroviral therapy (ART), and delay viral rebound after ART is temporarily stopped. The antibodies are designed to attach to HIV and prevent it from infecting new cells, and the study is exploring whether they might contribute to an HIV cure strategy. You may be eligible if you are an adult with confirmed HIV-1, have not previously taken ART (other than PrEP or PEP), have a CD4 count above 200 cells/mm3, and have a detectable viral load. Participation involves starting ART, receiving two antibody infusions by IV, then temporarily stopping ART under close monitoring with regular blood tests over an extended period. This summary was prepared using AI to help patients understand this research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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