A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
Public ClinicalTrials.gov record NCT05719441. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A5388 is a phase II, two-arm, randomized, double-blind, placebo-controlled study that will enroll 48 antiretroviral therapy (ART)-naïve adults with acute HIV infection (AHI) in order to determine whether: * Administration of combination HIV-specific broadly neutralizing antibody (bNAb) therapy in addition to ART during acute HIV infection (AHI) will be safe. * Participants who receive combination bNAb therapy in addition to ART during AHI will be more likely to demonstrate a delay in time to HIV-1 RNA ≥1,000 copies/mL for 4 consecutive weeks during an Analytical Treatment Interruption (ATI) compared to participants who receive placebo plus ART. * Participants who receive combination bNAb therapy in addition to ART during AHI will demonstrate lower viral reservoirs and enhanced HIV-specific immunity compared to participants who receive placebo plus ART.
Study identification
- NCT ID
- NCT05719441
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 48 participants
Conditions and interventions
Conditions
Interventions
- VRC07-523LS Biological
- PGT121.414.LS Biological
- Placebo Other
- ART Drug
Biological · Other · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 19, 2024 (Actual)
- Primary completion
- Jul 17, 2028 (Estimated)
- Completion
- Jun 18, 2029 (Estimated)
- Last update posted
- Oct 14, 2026
2024 – 2029
United States locations
- U.S. sites
- 9
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 31788, Alabama CRS | Birmingham | Alabama | 35222 | Recruiting |
| 6101, University of Colorado Hospital CRS | Aurora | Colorado | 80045 | Recruiting |
| 5802, The Ponce de Leon Center CRS | Atlanta | Georgia | 30308-2012 | Recruiting |
| 2701, Northwestern University CRS | Chicago | Illinois | 60611 | Recruiting |
| 31786, New Jersey Medical School Clinical Research Center CRS | Newark | New Jersey | 07103 | Not yet recruiting |
| 2301, Ohio State University CRS | Columbus | Ohio | 43210-1282 | Recruiting |
| 6201, Penn Therapeutics CRS | Philadelphia | Pennsylvania | 19104 | Recruiting |
| 31473, Houston Advancing Research Team CRS | Houston | Texas | 77030 | Recruiting |
| 1401, University of Washington Positive Research CRS | Seattle | Washington | 98104 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05719441, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05719441 live on ClinicalTrials.gov.