Can a vaccine cocktail free HIV patients from daily pills?
NCT ID NCT04357821
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This early-phase trial tests whether a combination of two experimental vaccines, an immune booster, and two powerful antibodies can help people with HIV control the virus after stopping their daily antiretroviral therapy. Eleven participants will receive the regimen while on ART, then pause their regular medication to see if the virus stays at bay. The goal is to achieve a lasting remission, not a cure, as the virus may still be present but kept under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- combination of DNA vaccine, MVA vaccine, TLR9 agonist (lefitolimod), and broadly neutralizing antibodies (VRC07-523LS and 10-1074)
- What this could lead to
- If it works, this could point toward a way for people with HIV to stop daily antiretroviral therapy and keep the virus under control for months or longer.
- What could go wrong
- This is a very small, early-phase study with only 11 participants, so results may not apply widely. The combination is complex and could cause side effects, and there is no guarantee of achieving remission.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
11 people
The number who actually took part.
- Started
-
Aug 2020
- Finished
-
Jun 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 67 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria 1. Willing and able to provide written informed consent. 2. Age ≤67 years at the time of enrollment for those who started treatment during early infection and \<65 years for those who started treatment during chronic infection. 3. Documented HIV-1 infection. 4. On continuous antiretroviral therapy for at least 12 months without any interruptions of greater than 14 consecutive days within the last 1 year, and on a stable regimen that does not include an non-nucleoside reverse transcriptase inhibitor (NNRTI) for at least 4 weeks, without plans to modify ART during the study period. 5. Screening plasma HIV RNA levels below the level of quantification on all available determinations in past 24 months. 6. Screening CD4+ T-cell count ≥ 500 cells/mm3. Key Exclusion Criteria 1. Subjects receiving a non-nucleoside reverse transcriptase inhibitor 2. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study 3. High-level resistance to both 10-1074 and VRC-07 as defined using the PhenoSense Neutralizing Antibody Assay (Monogram Biosciences). 4. Any history of an HIV-associated malignancy, including Kaposi's sarcoma and any type of lymphoma, or virus-associated cancers. 5. Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months. 6. CD4+ T cell nadir \<350 cells/mm3 during the chronic phase of infection (beginning 6 months following the estimated infection date and confirmed on repeat testing). 7. Active hepatitis B (HBV) infection defined as positive HBV surface antigen test. 9\. Active hepatitis C (HCV) infection. 10. Presence of significant abnormalities on electrocardiogram. 11. History of potential immune-mediated medical conditions. Individuals with isolated Raynaud's phenomenon or localized disease requiring topical therapy alone will not be excluded.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Zuckerberg San Francisco General Hospital, University of California San Francisco
San Francisco, California, 94110, United States
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Other studies related to the condition(s) this trial covers.
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