Acute HIV InfectionPhase 2NCT05719441
A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
A Phase 2 study testing VRC07-523LS, PGT121.414.LS and ART in people with Acute HIV Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute HIV Infection
- What is being tested?
- VRC07-523LS, PGT121.414.LS and ART
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 19 Aug 2024to 18 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Between 18 and 70 years of age
- Body weight under 115 kg (approximately 253 pounds)
- Evidence of recently acquiring HIV
- Not pregnant or breastfeeding
- No recent use of medications to prevent or treat HIV
- Able and willing to provide informed consent to study and its procedures which include
- initiating HIV medications (also called antiretroviral treatment or ART) following enrollment,
- A later, monitored pause in HIV medications (also called an analytical treatment interruption, or ATI)
- While pausing HIV treatment per study guidelines until resuppressed following treatment restart, agree to using barrier contraception to prevent HIV acquisition in sexual partners
- Agree to use effective contraception to prevent pregnancy in oneself and sexual partners who may become pregnant.
Trial locations and contacts
12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 3 countries
United States9 sites, 9 recruiting
- Recruiting
5802, The Ponce de Leon Center CRS
Atlanta, Georgia, 30308-2012
Ericka R. Patrick, 404-616-6313, erpatri@emory.edu
- Recruiting
6101, University of Colorado Hospital CRS
Aurora, Colorado, 80045
Nicola Haakonsen, 1-303-7240708, nicola.haakonsen@cuanschutz.edu
- Recruiting
31788, Alabama CRS
Birmingham, Alabama, 35222
Heather Logan, 205-873-8686, heatherlogan@uabmc.edu
- Recruiting
2701, Northwestern University CRS
Chicago, Illinois, 60611
Sherryl Wolfe, 312-695-4997, s-wolfe@northwestern.edu
- Recruiting
2301, Ohio State University CRS
Columbus, Ohio, 43210-1282
Jessica Marburger, 614-293-8112, jessica.marburger@osumc.edu
- Recruiting
31473, Houston Advancing Research Team CRS
Houston, Texas, 77030
Maria L. Martinez, 713-500-6718, maria.l.martinez@uth.tmc.edu
- Not yet recruiting
31786, New Jersey Medical School Clinical Research Center CRS
Newark, New Jersey, 07103
Rondalya DeShields, 973-972-3729, deshierd@njms.rutgers.edu
- Recruiting
6201, Penn Therapeutics CRS
Philadelphia, Pennsylvania, 19104
Jason Kirschner, 347-674-1545, Jason.Kirschner@Pennmedicine.upenn.edu
- Recruiting
1401, University of Washington Positive Research CRS
Seattle, Washington, 98104
Christine Jonsson, 206-744-8886, cjonsson@uw.edu
Brazil2 sites, 2 recruiting
- Recruiting
12201, Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS
Porto Alegre, 91350-180
Rita d. Lira, +55 51-33572603, lrita@ghc.com.br
- Recruiting
12101, Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, 21040-360
Brenda Hoagland, 55 21 38659122, brenda.hoagland@ini.fiocruz.br
Peru1 site, 1 recruiting
- Recruiting
11301, Barranco CRS
Lima, 15063
Consuelo Tristan Ramirez, 51-1-2067800 ext. 210, ctristan@impactaperu.org
About this study
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
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.
- Conditions
- Acute HIV Infection
- Being tested
- VRC07-523LS, PGT121.414.LS, Placebo, ART
- Keywords
- Acute HIV Infection, Broadly Neutralizing Antibodies, Analytical Treatment Interruption, Viral Reservoir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRC07-523LSBiological
Also called VRC-HIVMAB075-00-AB
10 mg/kg intravenous infusion over approximately 15 to 30 minutes once at entry
PGT121.414.LSBiological
Also called VRC-HIVMAB0107-00-AB
5 mg/kg intravenous infusion over approximately 30 to 60 minutes once at entry
PlaceboOther
Sodium Chloride for Injection USP, 0.9%
ARTDrug
Also called Biktarvy
Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablet orally once daily with or without food
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: VRC07-523LS + PGT121.414.LS + ART | Experimental | Not described Receives: Biological: VRC07-523LS; Biological: PGT121.414.LS; Drug: ART |
| Arm 2: Placebo + ART | Placebo comparator | Not described Receives: Other: Placebo; Drug: ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Grade ≥2 AE or SAE that are possibly, probably, or definitely related to the study bNAbs during initial ART treatment
Measured: Week 0 to end of initial ART treatment (scheduled to be 60 weeks)
Time from ART discontinuation to HIV-1 RNA ≥1,000 copies/mL for 4 consecutive weekly measurements during analytical treatment interruption (ATI)
Measured: From start of ATI through 24 weeks after ART interruption
Secondary outcomes (13)
Time from ART discontinuation to first documented HIV-1 RNA viral rebound of ≥50 copies/mL during ATI
Measured: From start of ATI through 24 weeks after ART interruption
Time from ART discontinuation to first documented HIV-1 RNA viral rebound of ≥200 copies/mL during ATI
Measured: From start of ATI through 24 weeks after ART interruption
Time from ART discontinuation to first documented HIV-1 RNA viral rebound of ≥1000 copies/mL during ATI
Measured: From start of ATI through 24 weeks after ART interruption
Proportion of study participants who undergo ATI with HIV-1 RNA <200 copies/mL at 24 weeks after ART interruption, without indication of ART restart
Measured: From start of ATI through 24 weeks after ART interruption
Time from ART discontinuation to ART restart for an HIV-related reason (virologic, immunologic and clinical criteria) during ATI
Measured: From start of ATI through 24 weeks after ART interruption
Frequency of participants maintained off ART at each visit during ATI
Measured: From start of ATI through 24 weeks after ART interruption
Change in CD4+/CD8+ T-cell counts during ATI
Measured: From start of ATI through 24 weeks after ART interruption
Area under the curve (AUC) of VRC07-523LS and PGT121.414.LS when administered together
Measured: Week 0 to end of ATI
Half-life of VRC07-523LS and PGT121.414.LS when administered together
Measured: Week 0 to end of ATI
Cmax of VRC07-523LS and PGT121.414.LS when administered together
Measured: Week 0 to end of ATI
Cmin of VRC07-523LS and PGT121.414.LS when administered together
Measured: Week 0 to end of ATI
Clearance (Cl/F) of VRC07-523LS and PGT121.414.LS when administered together
Measured: Week 0 to end of ATI
Volume of distribution of VRC07-523LS and PGT121.414.LS when administered together
Measured: Week 0 to end of ATI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start19 Aug 2024
- Primary completion17 Jul 2028 (estimated)
- Study completion18 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute HIV InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Trevor Crowell, MD, PhD, Study chair, U.S. Military HIV Research Program CTURoberto Arduino, MD, Study chair, Houston AIDS Research Team CRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719441
- Sponsor's protocol ID
- A5388
- Other IDs
- 38662
- Status last verified
- Oct 2026
- First submitted
- 30 Jan 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05719441
- Acronym / sponsor ID
- A5388
- Conditions
- Acute HIV Infection
- Keywords
- Acute HIV Infection, Broadly Neutralizing Antibodies, Analytical Treatment Interruption, Viral Reservoir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 17 Jul 2028 (estimated)
- Study completion
- 18 Jun 2029 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: VRC07-523LS + PGT121.414.LS + ART | Experimental | Biological: VRC07-523LS, Biological: PGT121.414.LS, Drug: ART |
| Arm 2: Placebo + ART | Placebo comparator | Other: Placebo, Drug: ART |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRC07-523LSAlso: VRC-HIVMAB075-00-AB10 mg/kg intravenous infusion over approximately 15 to 30 minutes once at entry | Biological | Arm 1: VRC07-523LS + PGT121.414.LS + ART |
| PGT121.414.LSAlso: VRC-HIVMAB0107-00-AB5 mg/kg intravenous infusion over approximately 30 to 60 minutes once at entry | Biological | Arm 1: VRC07-523LS + PGT121.414.LS + ART |
| PlaceboSodium Chloride for Injection USP, 0.9% | Other | Arm 2: Placebo + ART |
| ARTAlso: BiktarvyBictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablet orally once daily with or without food | Drug | Arm 1: VRC07-523LS + PGT121.414.LS + ART, Arm 2: Placebo + ART |
Primary outcome
Occurrence of Grade ≥2 AE or SAE that are possibly, probably, or definitely related to the study bNAbs during initial ART treatment
Time frame: Week 0 to end of initial ART treatment (scheduled to be 60 weeks)
Time from ART discontinuation to HIV-1 RNA ≥1,000 copies/mL for 4 consecutive weekly measurements during analytical treatment interruption (ATI)
Time frame: From start of ATI through 24 weeks after ART interruption
13 secondary outcomes
Time from ART discontinuation to first documented HIV-1 RNA viral rebound of ≥50 copies/mL during ATI
Time frame: From start of ATI through 24 weeks after ART interruption
Time from ART discontinuation to first documented HIV-1 RNA viral rebound of ≥200 copies/mL during ATI
Time frame: From start of ATI through 24 weeks after ART interruption
Time from ART discontinuation to first documented HIV-1 RNA viral rebound of ≥1000 copies/mL during ATI
Time frame: From start of ATI through 24 weeks after ART interruption
Proportion of study participants who undergo ATI with HIV-1 RNA <200 copies/mL at 24 weeks after ART interruption, without indication of ART restart
Time frame: From start of ATI through 24 weeks after ART interruption
Time from ART discontinuation to ART restart for an HIV-related reason (virologic, immunologic and clinical criteria) during ATI
Time frame: From start of ATI through 24 weeks after ART interruption
Frequency of participants maintained off ART at each visit during ATI
Time frame: From start of ATI through 24 weeks after ART interruption
Change in CD4+/CD8+ T-cell counts during ATI
Time frame: From start of ATI through 24 weeks after ART interruption
Area under the curve (AUC) of VRC07-523LS and PGT121.414.LS when administered together
Time frame: Week 0 to end of ATI
Half-life of VRC07-523LS and PGT121.414.LS when administered together
Time frame: Week 0 to end of ATI
Cmax of VRC07-523LS and PGT121.414.LS when administered together
Time frame: Week 0 to end of ATI
Cmin of VRC07-523LS and PGT121.414.LS when administered together
Time frame: Week 0 to end of ATI
Clearance (Cl/F) of VRC07-523LS and PGT121.414.LS when administered together
Time frame: Week 0 to end of ATI
Volume of distribution of VRC07-523LS and PGT121.414.LS when administered together
Time frame: Week 0 to end of ATI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.
Related trials for Acute HIV Infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Not yet recruitingPhase 1
huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers
Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
Not yet recruitingPhase 1
A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection
HIV-1-infection
Recruiting
Immuno-virological Evaluation of Persons Living With HIV (PLWH)
HIV-1-infection, HIV Seropositivity
RecruitingObservational study
Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection
HIV, Seroconversion, HIV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6101, University of Colorado Hospital CRS
Aurora, United States
Trevor Crowell, MD, PhD study chair
U.S. Military HIV Research Program CTU
Roberto Arduino, MD study chair
Houston AIDS Research Team CRS
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VRC07-523LS, PGT121.414.LS and ART in people with Acute HIV Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Brazil, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Grade ≥2 AE or SAE that are possibly, probably, or definitely related to the study bNAbs during initial ART treatment (time frame: Week 0 to end of initial ART treatment (scheduled to be 60 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.