Phase 1 HIV and AIDS Trial, Recruiting NCT07349758 Sponsor: Johns Hopkins University Condition: HIV and AIDS
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Phase 1 HIV and AIDS Trial, Recruiting

NCT07349758
Recruiting Phase 1

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 or older at the time of screening
  • People who are willing and able to give written consent to take part in the study
  • People who are in good general health, based on medical history, physical check-up, vital signs, and lab test results at screening
  • People whose recent HIV test (within four weeks of enrolling) came back negative
  • People whose kidneys are functioning well enough, based on a specific blood test measuring kidney filtration rate (confirm with trial site for exact threshold)
  • People who agree to use condoms for all sexual activity during the study
  • People who are willing to avoid taking any HIV prevention medication (PrEP) outside of what is provided by the study, for the full duration of the trial

Who may not be able to join:

  • People who have used oral PrEP medications (F/TDF or F/TAF) in the two months before joining the study
  • People whose HIV test at screening comes back positive or reactive
  • People who test positive for hepatitis B surface antigen, which indicates a hepatitis B infection
  • People who have had surgery that removed or altered part of their stomach or bowel, such as a gastrectomy, colostomy, or ileostomy, or any procedure that may affect how the body absorbs medication
  • People with a recent history of behaviours considered high-risk for HIV, such as sharing needles or having unprotected sex with one or more partners in the two weeks before screening
  • People currently taking certain medications that are known to interfere with how the body absorbs the study drug (confirm specific medications with trial site)
  • People who are pregnant or breastfeeding
  • People with serious, uncontrolled, or progressive health conditions — including issues related to substance use, kidney, liver, blood, digestive, hormonal, lung, nerve, or brain health — that a doctor determines would make participation unsafe or unsuitable

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 27 July 2026
Phase 1: approximately ~10% 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: Sunil Solomon, MD, Johns Hopkins University

Phone: 410-955-1318

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 1
Registry
ClinicalTrials.gov
Start date
6 January 2026
Est. completion
1 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Intracellular tenofovir-diphosphate concentrations (fmol/10^6)

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: 27 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