Actively Recruiting
RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV
Led by Henry M. Jackson Foundation for the Advancement of Military Medicine · Updated on 2025-09-16
48
Participants Needed
1
Research Sites
122 weeks
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
This is a phase I, randomized, double-blind, placebo-controlled clinical trial to investigate the safety of VRC07-523LS and PGDM1400LS in combination with ChAdOx1.tHIVconsv1, ChAdOx1.HIVconsv62 prime, MVA.tHIVconsv4 and A244d11gp120/ALFQ vaccination, and the impact on viral load setpoint during analytic treatment interruption (ATI) in people living with human immunodeficiency virus-1 (HIV-1, PLWH) who have initiated or will initiate antiretroviral therapy (ART) during acute HIV-1 infection (AHI).
CONDITIONS
Official 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 diagnosed during acute infection
- Started antiretroviral therapy during acute infection
- Uninterrupted ART for at least 48 weeks
- Currently on integrase inhibitor-based ART regimen with no recent changes
- Documented plasma HIV-1 RNA below 50 copies/mL for at least 48 weeks
- CD4 T-cell count of 400 cells/mm3 or higher
- Absolute neutrophil count of at least 1,000/mm3
- Hemoglobin greater than 11.5 g/dL
- Platelet count of at least 150,000/mm3
- Estimated glomerular filtration rate of 60 mL/min/1.73m2 or higher
- Liver enzymes and bilirubin less than 1.5 times the upper limit of normal
- Negative Hepatitis C virus antibody or RNA test
- Sensitivity testing showing no resistant viruses to study antibodies
- Negative pregnancy test for persons of childbearing potential
- Agreement to use two methods of contraception if sexually active
- Agreement to use condoms to prevent pregnancy and HIV transmission
- Willingness to abstain from sexual intercourse, use condoms, or have partners use pre-exposure prophylaxis during treatment interruption
- Passes Test of Understanding
- Willing to interrupt and restart ART as scheduled
- Willing to participate and follow study restrictions during all visits and follow-up
You will not qualify if you...
- Weight under 50 kg or over 115 kg
- Presence of HLA B*57:01 allele associated with viral control
- Contraindications to intramuscular injections, intravenous lines, or blood draws
- Acute or serious illness requiring treatment or hospitalization within 90 days prior to entry
- Clinically significant acute or chronic medical conditions that preclude participation
- Active or chronic hepatitis B infection
- Hepatitis C treatment or positive RNA within 6 months
- Receipt of licensed or emergency vaccines within specified timeframes around study product administration
- Plans to receive MVA-vectored licensed vaccines near study vaccinations
- Receipt of investigational agents within 12 months prior to screening
- Previous immunoglobulin or monoclonal antibody therapy within specified periods
- Previous participation in HIV vaccine studies or immune prophylaxis with active product
- Use of immunomodulatory medications within 6 months prior to study entry
- Known allergy or serious reactions to vaccines or vaccine components
- History of severe allergic reactions within 2 years before enrollment
- History of chronic urticaria or recurrent eczema/atopic dermatitis
- History of splenectomy
- Pregnant, breastfeeding, or planning pregnancy during study
- Major psychiatric illness or substance use interfering with participation
- Virologic failure after study entry
- Recent use of non-nucleoside reverse transcriptase inhibitors
- Use of long-acting ART drugs after study entry
- Failure to attend three consecutive study visits
- Active drug or alcohol use impairing adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
D
Donn Colby, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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