Phase 2 HIV and AIDS Trial, Recruiting NCT04648046 Sponsor: Steven Deeks Condition: HIV and AIDS
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Phase 2 HIV and AIDS Trial, Recruiting

NCT04648046
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 65 years old, of any sex
  • People who have been diagnosed with HIV-1
  • People who have been on continuous HIV treatment for at least 12 months, with no breaks longer than 14 days in a row, and who have been on a stable treatment plan for at least 4 weeks that does not include a specific class of HIV drugs called NNRTIs or any long-acting HIV medications
  • People whose HIV has been undetectable in their blood for the past 12 months (one or two low-level blips in results may still be acceptable — confirm with trial site)
  • People whose lowest-ever recorded immune cell count (CD4+ T cells) was above 300 cells/mm³
  • People whose most recent immune cell count is at or above 500 cells/mm³
  • People who have a full record of their HIV treatment history available, and for whom an effective backup treatment plan could be put together if needed
  • People who are willing to temporarily pause their HIV treatment as part of the study

Who may not be able to join:

  • People who are pregnant, breastfeeding, or not willing to use contraception during the study
  • People whose current HIV treatment includes a long-acting HIV drug or an NNRTI that could remain active in the body for up to one year after stopping treatment
  • People whose current HIV treatment includes drugs known as protease inhibitors and/or AZT, as these may increase the risk of side effects from one of the study drugs
  • People who have ever had a cancer linked to HIV, such as Kaposi's sarcoma or any type of lymphoma, or cancers caused by viruses
  • People who have a current or past hepatitis B infection, based on specific blood test results (confirm with trial site)
  • People who currently have an active hepatitis C infection
  • People who have active or latent (dormant) tuberculosis
  • People who have long-term liver disease
  • People who have heart or blood vessel disease that is currently active and not well managed
  • People who are not willing to either abstain from sex or use barrier protection (such as condoms) during the period when HIV treatment is paused

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Steven Deeks, MD, University of California, San Francisco

Phone: 415-476-4082

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Steven Deeks
Registry
ClinicalTrials.gov
Start date
1 March 2021
Est. completion
31 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of participants reporting a new Grade 3 or greater adverse event that is definitely, probably, or possibly related to study treatment within 1 year of product administration.; Number of participants achieving post-treatment control within 36 weeks of product administration.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov