N/A N=13 Other

Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 703/HPTN 081 AMP Study

HIV Infection

Bottom Line

View on ClinicalTrials.gov: NCT04860323 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Time to Meeting Criteria for ART Re-initiation — 17.1; 10.1; 13.3 Weeks

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Analytical Treatment Interruption (Other)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: HIV Vaccine Trials Network
Primary completion: Feb 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Meeting Criteria for ART Re-initiation	17.1; 10.1; 13.3	—
PRIMARY Frequency of Sustained Post-treatment HIV Control, Defined as ≥ 24 Weeks Off ART Without Meeting ART Re-initiation Criteria	1; 0; 1	—
PRIMARY Percentage of Participants Who Experience Adverse Events (AEs)	5; 2; 6	—
PRIMARY Number of Participants Reporting Serious Adverse Events (SAEs)	0; 0; 0	—
PRIMARY Percent of Participants Who Discontinue ATI	2; 2; 3; 0; 0; 0	—
PRIMARY Number of Local Laboratory Values Meeting Grade 2 AE Criteria or Above	5; 1; 1; 0; 0; 1	—
SECONDARY Cumulative Incidence of Participants With First Viral Load ≥ 200 Copies/mL at Week 8, 16, and 24 of Schedule 1: Monitoring ATI	4; 3; 4; 4; 4; 4	—
SECONDARY Response Rate of HIV-specific CD4+ and CD8+ T-cells	—	—
SECONDARY Magnitude of HIV-specific CD4+ and CD8+ T-cells	—	—
SECONDARY Magnitude of Neutralizing Antibodies (nAb) Responses Against Autologous and Global HIV Panel Isolates	—	—
SECONDARY Non-neutralizing, FcγR-mediated Antibody Effector Functions Measured by ADCC	—	—
SECONDARY Non-neutralizing, FcγR-mediated Antibody Effector Functions Measured by ADCP	—	—
SECONDARY Non-neutralizing, FcγR-mediated Antibody Effector Functions Measured by Virion Capture	—	—
SECONDARY Frequency of Dendritic Cell Activation and Maturation Markers	—	—
SECONDARY Frequency of T- and B-cell Activation and Exhaustion Markers	—	—
SECONDARY Frequency of CD4+ T Cells Carrying Intact and/or Total Pro-viral HIV DNA, Replication Competent Virus, and/or Cell-associated HIV RNA	—	—

Summary

The purpose of this study is to learn whether having the AMP Study antibody (called VRC01) in a person's body might help their immune system control HIV better, even without HIV medication called antiretroviral therapy or ART, if they get HIV. This study will evaluate the viral and immune system responses in an Analytical Treatment Interruption (ATI), in participants who received VRC01 or placebo and got HIV while enrolled in HVTN 703/HPTN 081 (NCT02568215). Participants in this study will stop taking their HIV medication. They will stay off HIV medication unless and until the HIV levels in their blood show that their immune system is unable to control the HIV or they meet other ART re-start criteria as noted in section "Detailed Description". While they are not taking HIV medication, their HIV levels will be tested frequently, and their health will be monitored closely. This is called an analytical treatment interruption, or an ATI. An ATI is an experimental procedure that is only used in carefully monitored research.

Eligibility Criteria

Inclusion Criteria

Estimated date of HIV-1 acquisition within 8 weeks (ie, before or after) having received an HVTN 703/HPTN 081 infusion.
Initiated ART within 28 weeks of HVTN 703/HPTN 081 date of HIV-1 diagnosis.
Receiving continuous ART for at least 1 year. ART interruptions of up to 7 days in duration and ≥ 90 days prior to enrollment are acceptable. Within- and between-class changes in ART within the previous year are acceptable.
If on an NNRTI, willingness and ability to switch to a PI- or INSTI-containing regimen for at least 4 weeks prior to ART interruption.
Willingness to interrupt ART for up to 24 weeks or up to the time of meeting ART re-initiation criteria.
Willingness to re-initiate ART upon meeting study ART re-initiation criteria.
Willingness to use barrier protection (ie, male or female condoms) for all sexual activity during ATI and until confirmation of viral suppression following ART re-initiation.
Willingness for CRS staff to contact primary HIV care provider to exchange information regarding HVTN 805/HPTN 093 and participant medical history.
Site investigator anticipates that a fully active alternative ART regimen could be constructed and would be available in the event of virologic failure on the participant's current ART regimen.
Access to a participating CRS and willingness to adhere to study visit schedule and to be followed for the planned duration of the study.
Ability and willingness to provide informed consent.
Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to enrollment with verbal demonstration of understanding of all questionnaire items answered incorrectly.
Agrees not to enroll in another study of an investigational research agent for the duration of the participant's trial participation.

Laboratory Inclusion Values:

Immunology/Virology

HIV-1 infection, with reactive HIV-1 antibody and any Multispot or Geenius HIV-1/HIV-2 results, documented by the HVTN 703/HPTN 081 HIV diagnostic algorithm.
Plasma HIV-1 RNA ≥ 1, 000 copies/mL by any assay, prior to initiating ART.
CD4+ T cell count ≥ 450 cells/mm3 obtained within 90 days prior to enrollment.
One plasma HIV-1 RNA below the lower limit of quantitation (LLOQ) of an VQA-certified or DAIDS-approved assay and collected at each of the following:
at screening, within 90 days prior to enrollment; and
greater than 9 months prior to the screening HIV-1 RNA. Note: Sites must have results from locally available assays that are approved as standard-of-care by their regional governing bodies.

Hematology

Hemoglobin (Hgb) ≥ 10.0 g/dL
Absolute neutrophil count (ANC) ≥ 750 cells/mm3
Platelets ≥ 100,000 cells/mm3

Chemistry

Alanine aminotrasferase (ALT) 60 mL/min/1.73m2

Reproductive Status

Volunteers capable of becoming pregnant: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed at the screening visit and prior to enrollment. Persons who are NOT capable of becoming pregnant due to having reached menopause (no menses for 1 year) or having undergone total hysterectomy or bilateral oophorectomy or tubal ligation (verified by medical records) are not required to undergo pregnancy testing.
Reproductive status: A volunteer who is capable of becoming pregnant must agree to consistently use effective contraception (ie, IUD or hormonal) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through confirmation of viral suppression following ART re-initiation.
Volunteers capable of becoming pregnant must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization, until after confirmation of viral suppression following ART re-initiation.

Exclusion Criteria

Any plasma HIV-1 RNA ≥ LLOQ of VQA-certified or DAIDS-approved assay (LLOQ: 75, 50, 40, or 20 copies/mL) within 12 months prior to enrollment. NOTE: Two

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04860323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.