NCT04357821CompletedPhase 1/2
Combinatorial Therapy to Induce an HIV Remission
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
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 18 Apr 2020
- Start date
- 1 Aug 2020
- Primary completion date
- 29 Jan 2024
- Lead sponsor
- University of California, San Francisco
- Diseases
- HIV
- NCT number
- NCT04357821
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 11
- From 1 Aug 2020 to the primary completion date, 29 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects receiving a non-nucleoside reverse transcriptase inhibitor
- High-level resistance to both 10-1074 and VRC-07 as defined using the PhenoSense Neutralizing Antibody Assay (Monogram Biosciences).
Other illness
- Any history of an HIV-associated malignancy, including Kaposi's sarcoma and any type of lymphoma, or virus-associated cancers.
- 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.
- 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).
- 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.
Other
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
Who the study is looking for
- Willing and able to provide written informed consent.
- 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.
- Documented HIV-1 infection.
- 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.
- Screening plasma HIV RNA levels below the level of quantification on all available determinations in past 24 months.
- Screening CD4+ T-cell count ≥ 500 cells/mm3.
Age in the registry: 18 years to 67 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zuckerberg San Francisco General Hospital/University of California, San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
Related publications
- Correlates of HIV-1 control after combination immunotherapy.Nature · 2026 · PMID 41326736
This page is information, not medical advice. Discuss any trial with your doctor.