Phase 4 HIV and AIDS Trial, Recruiting NCT06967753 Sponsor: UBATEC Condition: HIV and AIDS
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Phase 4 HIV and AIDS Trial, Recruiting

NCT06967753
Recruiting Phase 4

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 who are 18 years of age or older at the time of signing the consent form
  • People who self-identify as a transgender woman
  • People who have a confirmed HIV-1 diagnosis, shown by at least two different blood tests or a measurable level of HIV in the blood
  • People who have been on a stable, uninterrupted, three-drug HIV treatment regimen for at least 3 months before the screening visit, with no history of switching medications due to treatment failure
  • People who have had at least two HIV blood tests showing very low (undetectable) virus levels in the past 12 months
  • People whose HIV virus levels are undetectable at the screening visit
  • People with no history of their HIV treatment stopping working, and no evidence of resistance to the drugs dolutegravir (DTG) or lamivudine (3TC)
  • People who are able to understand and follow the study requirements
  • People who have provided written agreement to participate

Who may not be able to join:

  • People who have had an allergic reaction to any of the study medications or their ingredients
  • People with a current active Hepatitis B or Hepatitis C infection (note: people with past Hepatitis B or successfully treated/cleared Hepatitis C may still be considered — confirm with trial site)
  • People with untreated syphilis at the time of screening (those who completed treatment at least 7 days before may still be considered)
  • People with an active, serious HIV-related illness, except for certain skin conditions that do not require systemic treatment (people who are stable and receiving appropriate treatment for an HIV-related illness may still be considered — confirm with trial site)
  • People with an active cancer, other than certain limited skin cancers or specific non-invasive growths listed in the protocol
  • People with severe liver disease, classified as Child-Pugh Class C
  • People whose past resistance tests show that their HIV has developed resistance to certain key medications in the study regimen
  • People who, in the treating doctor's judgment, are at significant risk of suicide or self-harm
  • People currently taking other medications that are known to interact significantly with dolutegravir (DTG) or lamivudine (3TC)
  • People who have received an HIV vaccine as part of a study within 90 days before screening
  • People who have had radiation therapy, chemotherapy, or immune-suppressing treatment within 28 days before screening
  • People who have participated in another experimental drug or vaccine study within a specified recent period before the first study dose
  • People whose blood test results at screening show certain serious abnormalities, including very low red blood cell levels, low white blood cell counts, low platelet counts, poor kidney function, or significantly elevated liver enzyme levels
  • People with any other condition — including alcohol or drug misuse — that the doctor running the trial believes could affect the person's safety or ability to follow the study requirements

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 16 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Martín Jaume, MD, Hospital Fernández, Infectious Diseases Division

Phone: +54 11 4808-2600

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 4
Sponsor
UBATEC
Registry
ClinicalTrials.gov
Start date
31 July 2025
Est. completion
1 December 2026

Where this trial is recruiting

🇦🇷 Argentina

Primary endpoints

Virological efficacy

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: 16 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