NCT04357821

Combinatorial Therapy With a Therapeutic Conserved Element DNA Vaccine, MVA Vaccine Boost, TLR9 Agonist and Broadly Neutralizing Antibodies: a Proof-of-concept Study Aimed at Inducing an HIV Remission

Active, enrolled Phase 1/Phase 2 Results posted Last updated 19 February 2026

What this trial tests

Phase 1/Phase 2 trial testing Combination Intervention in HIV/AIDS in 11 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 August 2020

Primary endpoint
1 June 2026

1 June 2026

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 1/Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	1 August 2020
Primary completion	1 June 2026
Estimated completion	1 June 2026
Sites	1 location across United States

Drugs / interventions tested

• Combination Intervention

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

University of California, San Francisco

Who can join

Adults 18 to 67, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Grade 3 or Greater Adverse Event Count
  Time frame: Week 0 through 102
  Number of participants who experience a new grade 3 or greater adverse event
• Proportion of Participants Achieving Post-treatment Control
  Time frame: Week 34 through 86
  This will be defined as: 1. Participants who fail to show any consistent rebound above 400 copies RNA/mL between Week 12 of the ATI (when bNAb levels wane) and Week 36 of the ATI 2. Participants who exhibit a rebound and eventually achieve 24 weeks of virus control will be considered as having achieved post-treatment control

Sponsor's own description

Combination approaches will almost certainly be required to generate durable control of HIV in the absence of antiretroviral therapy (a "remission"). In this study, 20 individuals will receive a combination regimen administered during ART and then undergo an analytic treatment interruption (ATI).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The next-generation DNA vaccine platforms and delivery systems: advances, challenges and prospects.
   Lu B, Lim JM, Yu B, Song S, et al · · 2024 · cited 84× · PMID 38361919 · DOI 10.3389/fimmu.2024.1332939
2. Toll-Like Receptors as a Therapeutic Target in the Era of Immunotherapies.
   Farooq M, Batool M, Kim MS, Choi S. · · 2021 · cited 70× · PMID 34671606 · DOI 10.3389/fcell.2021.756315
3. Immune targeting of HIV-1 reservoir cells: a path to elimination strategies and cure.
   Armani-Tourret M, Bone B, Tan TS, Sun W, et al · · 2024 · cited 44× · PMID 38337034 · DOI 10.1038/s41579-024-01010-8
4. Broadly neutralizing monoclonal antibodies for HIV prevention.
   Miner MD, Corey L, Montefiori D. · · 2021 · cited 34× · PMID 34806308 · DOI 10.1002/jia2.25829
5. Can Broadly Neutralizing HIV-1 Antibodies Help Achieve an ART-Free Remission?
   Hsu DC, Mellors JW, Vasan S. · · 2021 · cited 30× · PMID 34322136 · DOI 10.3389/fimmu.2021.710044
6. The RIO trial: rationale, design, and the role of community involvement in a randomised placebo-controlled trial of antiretroviral therapy plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) in participants diagnosed with recent HIV infection-study protocol
   Lee MJ, Collins S, Babalis D, Johnson N, et al · · 2022 · cited 24× · PMID 35382844 · DOI 10.1186/s13063-022-06151-w
7. Analytical Treatment Interruption in HIV Trials: Statistical and Study Design Considerations.
   Zheng L, Tierney C, Bosch RJ. · · 2021 · cited 22× · PMID 34213731 · DOI 10.1007/s11904-021-00569-8
8. Clinical trials of broadly neutralizing monoclonal antibodies in people living with HIV - a review.
   Mahomed S, Pillay K, Hassan-Moosa R, Galvão BPGV, et al · · 2025 · cited 20× · PMID 40189566 · DOI 10.1186/s12981-025-00734-8