Principal Investigator: Ayotunde E. Omoz-Oarhe(MD,MPH)

Study Objectives:

Primary Objectives

• To evaluate the safety of 3BNC117-LS and 10-1074-LS at ART initiation in adults living with HIV in Sub-Saharan Africa
• To evaluate the impact of combination bNAb therapy plus ART as compared placebo plus ART on the time to sustained HIV-1 RNA ≥ 1000 copies/mL over a 4-week period.

Secondary Objectives

• To evaluate time from ART discontinuation to meeting virologic, immunologic, or clinical criteria (ie, viral load, CD4+Tcell count, or development of severe acute retroviral syndrome) for ART restart.
• To determine the liability of 3BNC117-LS and 10-1074-LS at ART initiation to induce post-intervention control (defined as not meeting ART restart criteria through 24 weeks after ART interruption.
• To determine the effects of 3BNC117-LS and 10-1074-LS at ART initiation on the HIV reservoir.
• To determine the effects 3BNC117-LS and 10-1074-LS at ART initiation on HIV-1 specific cellular immune responses.
• To describe the pharmacokinetic parameters of 3BNC117-LS and 10-1074-LS at ART initiation.
• To assess the frequency and magnitude of treatment-induced anti-drug antibody responses (anti-3BNC117-LS and anti-10-1074-LS antibodies).

Study Design: This a randomized, double-blind, placebo-controlled study of the combination of two long-acting broadly neutralizing antibodies (bNAbs-3BNC117-LS and 10-1074-LS) at antiretroviral therapy (ART) initiation in adults living with HIV in sub-Saharan Africa.

Study Population:

The study will enrol;

• People living with HIV
• ART naïve
• ≥ 18 and ≤ 60 years and with
• No history of receipt of any therapeutic HIV vaccine or HIV monoclonal therapy.

Sample Size:

135 participants will be enrolled across all the participating sites and randomized in a 2:1 ratio in a double-blinded fashion to receive either bNAbs (3BNC117-LS and 10-1074-LS) infusions with ART (Group 1: n=90) or placebo infusions with ART (Group 2: n=45).

Study duration: 3.5 years

Sponsor: National Institute of Allergy and Infectious Diseases