Study of VRC07-523LS and PGT121.414.LS with ART for Acute HIV Infection
This study is looking at adults with recent HIV infection (Acute HIV Infection) who have not yet started HIV medication (ART-naïve). It aims to see if adding two specific antibodies, VRC07-523LS and PGT121.414.LS, to standard HIV treatment (ART: Bictegravir/emtricitabine/tenofovir alafenamide) is safe. Researchers also want to know if this combination can delay the return of high levels of HIV in the blood after stopping ART. You can join if you are between 18 and 70 years old and have a recent diagnosis of Acute HIV Infection. The study will enroll 48 participants and is currently unclear regarding its recruitment status.
- Study design
- This is a Phase 2, two-arm, randomized, double-blind, placebo-controlled study involving 48 participants.
- What's involved
- Participants will receive VRC07-523LS, PGT121.414.LS, or a placebo once at entry, along with daily ART. The study measures safety during Step 1 and the time to HIV-1 RNA increase after ART interruption during Step 2.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from Step 2 entry through 24 weeks after ART interruption to measure the time until HIV-1 RNA levels reach 1,000 copies/mL for 4 consecutive weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05719441
A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
Recruiting
PHASE2Ages 18–70InterventionalTreatmentNational Institute of Allergy and Infectious Diseases (NIAID)Government-funded
~48 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:VRC07-523LSPGT121.414.LSPlaceboART
At a glance
Recruiting sites
7 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of Grade ≥2 AE or SAE that are possibly, probably, or definitely related to the study bNAbs during Step 1
Measured over Week 0 to end of Step 1
+1 more outcome measured
Conditions
Where it's being run
36 sites across 21 statesCalifornia5
New York4
Ohio3
Illinois2
Massachusetts2
North Carolina2
Pennsylvania2
Texas2
Study leadership
- Trevor Crowell, MD, PhD · STUDY_CHAIR · U.S. Military HIV Research Program CTU
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Absolute neutrophil count (ANC) ˃1,000/mm3
Hemoglobin:
\>10 g/dL for cisgender men and transgender women
\>9 g/dL for cisgender women and transgender men
Platelet count ˃100,000/mm3
Estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation, with consideration for lower rates in special circumstances.
ALT (SGPT) ≤2.5 x ULN
AST (SGOT) ≤2.5 x ULN
Total bilirubin \<1.5 x ULN 3. For persons who are able to become pregnant, negative urine or serum pregnancy test within 24 hours prior to study entry. 4. Persons who are able to become pregnant must agree to use two methods of contraception throughout Step 1 if participating in sexual activity that could lead to pregnancy. One contraceptive method must be a highly effective method and the second method of contraception must be a barrier method. 5. Participants of reproductive potential who engage in sexual activity that could lead to their partner's becoming pregnant must agree to use a barrier method of contraception throughout Step 1. 6. Ability and willingness to use a barrier method or abstinence from sexual intercourse with all partners who are vulnerable to HIV or whose HIV serostatus is unknown in order to prevent HIV transmission during Step 2, Step 3, and until plasma HIV-1 RNA is less than the limit of detection after ART restart in Step 4. 7. Age ≥18 and ≤70 years. 8. Ability and willingness to initiate ART at enrollment. 9. Ability and willingness to participate in scheduled study visits, including during the ATI, per Schedule of Evaluations (SOE). 10. Ability and willingness of participant to provide informed consent.
Exclusion
Acute myocardial infarction
Acute coronary syndromes
Stable or unstable angina
Coronary or other arterial revascularization
Stroke
TIA
Peripheral arterial disease presumed to be of atherosclerotic origin 14. Currently breastfeeding or pregnant. 15. Weight \>115 kg. 16. Use of prohibited medications for bictegravir, emtricitabine, and tenofovir alafenamide (refer to protocol section 5.8) within 7 days prior to entry, or planned use of prohibited medications during the period of study participation. 17. Absence of adequate venous access for the administration of infusion or for phlebotomy to assess for the primary study endpoint.
What this trial measures
- Occurrence of Grade ≥2 AE or SAE that are possibly, probably, or definitely related to the study bNAbs during Step 1Week 0 to end of Step 1
- Time from ART discontinuation to HIV-1 RNA ≥1,000 copies/mL for 4 consecutive weeks during Step 2From Step 2 entry through 24 weeks after ART interruption