A5389: Two bNAb Combination for Acute HIV-1 Infection

HIV Cure, Treatment Experienced

This study will evaluate the combination of two experimental broadly neutralizing antibodies (bNAbs) in participants who started anti-HIV medications (also known as antiretroviral therapy, or “ART”) soon after acquiring HIV (acute infection) and have maintained control of HIV for at least 1 year while on ART. This study will also look at how well HIV is controlled after temporarily stopping ART at different times after receiving the experimental bNAbs.

• To evaluate the combination of two experimental bNAbs in participants who started anti-HIV medications soon after acquiring HIV.
• To look at how well HIV is controlled after temporarily stopping ART at different times after receiving the experimental bNAbs.

• Age 18 to 70 years, living with HIV
• Low level of HIV for at least the past 1 year
• Started taking ART during acute/early infection, and consistently taking ART for at least 12 months
• No known ART interruption for longer than 14 days within 12 months
• No more than two known ART interruptions of a duration between 14 and 60 consecutive days since initiation of ART
• Willingness to interrupt ART under supervision of the study team during the study and restart ART according to study requirements
• CD4+ cell count of higher than 450 cells/mLprior to study entry
• No active hepatitis B or C
• No long-acting injectable ART within the past 2 years
• No previous anti-HIV bNAb therapy

Depending on when you enroll, you will be in one of two study groups (Arm A or B), which have different schedules. Both groups of participants will receive VRC07-523LS and PGT121.414.LS and a second infusion of VRC07-523LS 12 weeks (about 3 months) after entering the study.

• The first group will temporarily stop ART 2 weeks after entering the study.
• The second group of participants will temporarily stop ART 50 weeks (about 1 year) after entering the study.

You will receive the experimental drugs VRC07-523LS and PGT121.414.LS. These study drugs are not approved by the US Food and Drug Administration (FDA).

The maximum time you will be in the study is about 98 weeks.