Actively Recruiting
RV630 - Safety and Efficacy of Broadly Neutralizing Antibodies Combined with Therapeutic Vaccination to Induce HIV Remission
Led by Henry M. Jackson Foundation for the Advancement of Military Medicine · Updated on 2025-09-16
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead Sponsor
U
US Military HIV Research Program
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and effects of combining two broadly neutralizing antibodies, VRC07-523LS and PGDM1400LS, with a series of HIV vaccines in people living with HIV-1 who started antiretroviral therapy (ART) during acute HIV infection. This phase I, randomized, double-blind, placebo-controlled trial aims to assess how this combination influences viral load after stopping ART temporarily, known as analytic treatment interruption (ATI). The trial includes three groups: two groups of participants already on ART who are virologically suppressed and meet specific immune and viral criteria, and one exploratory group newly diagnosed with acute HIV infection who have not yet started ART. Treatments include the antibodies administered at the start of Step 2, ART initiation or continuation, and multiple vaccinations given at scheduled weeks. The active group receives the antibodies plus three vaccinations, the comparator group receives antibodies plus placebo vaccinations, and the exploratory group starts ART earlier with a delayed vaccination schedule. Participants will be monitored closely throughout the study with regular laboratory tests, including viral load and immune cell counts, safety assessments, and evaluations of immune responses. The study will measure safety over 50 to 100 weeks and track viral rebound and immune effects during ATI for up to 50 weeks. Participants must follow strict treatment interruption and restart schedules and adhere to study requirements, including contraception and sexual activity guidelines, during the study period.
CONDITIONS
Brief Title
RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Thai National
- Age 18 to 60 years
- Can read and write Thai
- Able and willing to provide written informed consent
- Confirmed HIV-1 infection and started ART during acute infection
- Uninterrupted ART treatment for 48 weeks or more
- Currently on integrase inhibitor-based ART regimen with stable viral suppression
- Medically stable based on medical history, physical exam, and lab tests
- CD4 T-cell count 400 cells/mm3 or higher
- Hemoglobin above 11.5 g/dL
- Platelet count 150,000/mm3 or higher
- Estimated glomerular filtration rate 60 mL/min/1.73m2 or higher
- Liver enzymes and bilirubin within acceptable limits
- Negative hepatitis C virus antibody or RNA test
- HIV-1 RNA less than 50 copies/mL for at least 48 weeks
- Viruses sensitive to study antibodies
- Negative pregnancy test for persons of childbearing potential
- Agree to use contraception and comply with sexual activity guidelines
- Willing to interrupt and restart ART as per study schedule
- Passes test of understanding
- Willing to adhere to all study restrictions and visits
You will not qualify if you...
- Weight less than 50 kg or more than 115 kg
- Presence of HLA B*57:01 allele
- Contraindications to injections, IV lines, or blood draws
- Serious illness requiring treatment or hospitalization within 90 days
- Significant medical conditions that preclude participation
- Active or chronic hepatitis B infection
- Recent hepatitis C treatment or infection
- Recent vaccination or planned vaccination conflicting with study vaccines
- Receipt of investigational agents within 12 months
- Previous immunoglobulin or monoclonal antibody therapy within 12 months
- Previous participation in certain HIV vaccine studies
- Use of immunomodulatory medications within 6 months
- Known allergies or severe reactions to vaccines or vaccine components
- History of severe allergic reactions or chronic skin conditions
- History of splenectomy
- Pregnant, breastfeeding, or planning pregnancy during study
- Major psychiatric illness or substance use interfering with participation
- Virologic failure or recent NNRTI or long-acting ART use
- Failure to attend consecutive study visits
- Active drug or alcohol dependence interfering with adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 20 to 28 weeks depending on group assignment
Participants receive investigational antibodies and vaccinations combined with antiretroviral therapy (ART) according to their assigned group.
Multiple visits including dosing at Weeks 0, 1, 4, 12, 20, and optionally Week 28 depending on group
Duration - Up to 50 weeks after treatment interruption
Participants are monitored for safety, immune response, and viral load during analytic treatment interruption (ATI) after completing active treatment.
Regular visits for up to 50 weeks following treatment interruption
Trial Site Locations
Total: 1 location
1
The Faculty of Medicine, Chulalongkorn University/ King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, Thailand, 10330
Actively Recruiting
Research Team
K
Kiat Ruxrungtham, MD
D
Donn Colby, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here