Phase 2 study for people with HIV and AIDS

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor Gilead Sciences
Registry number NCT07645287
Started 15 June 2026 Today 16 October 2026 Estimated completion 1 August 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Taylor Square Private Clinic Surry Hills NSW Recruiting
Momentum Clinical Research Darlinghurst Sydney NSW Recruiting
East Sydney Doctors Sydney NSW Recruiting
Prahran Market Clinic, South Yarra VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 175

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Key Inclusion Criteria:

* Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL for ≥ 6 months before screening.

* Plasma HIV-1 RNA levels \< 50 copies/mL at screening.

* Receiving bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®) (B/F/TAF) for ≥ 6 months prior to screening.

* No documented resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S).

Key Exclusion Criteria:

* Prior use of, or exposure to GS-3242 or LEN.

* History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen.

* Prior use of any long-acting parenteral antiretroviral therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Dates on the record

Started 15 June 2026
Estimated completion 1 August 2027
Registry last updated 15 October 2026
Checked by Voxsanity 15 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 15 October 2026.
  • This page last checked by Voxsanity: 15 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.