Phase 2 HIV and AIDS Trial, Recruiting NCT04513626 Sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida Condition: HIV and AIDS
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Phase 2 HIV and AIDS Trial, Recruiting

NCT04513626
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:

  • You are 18 years old or older
  • You have been diagnosed with HIV-1
  • Your CD4 cell count (a measure of immune system strength) is at least 200/mm³
  • You have been on a stable HIV treatment regimen of at least 2 medications for at least 6 months
  • Your HIV viral load (the amount of HIV in your blood) has stayed at or below 50 copies/mL for the past 12 months, with at most one small temporary rise (between 51–200 copies/mL) that returned back down (confirm with trial site)
  • You have never taken the HIV medication doravirine before
  • Your HIV virus does not show resistance (reduced response) to the medications doravirine or raltegravir, based on genetic testing of the virus
  • You have signed a consent form agreeing to take part
  • You are covered by a social health insurance programme (for patients in France, State Medical Aid/AME does not qualify)

Who may not be able to join:

  • No genetic test results are available for your HIV virus, and a new test at the start of the trial also could not produce results (confirm with trial site)
  • You also have hepatitis B (HBV) infection
  • Your haemoglobin level (a measure of red blood cells) is below 9 g/dL
  • Your platelet count (cells that help blood clot) is below 80,000/mm³
  • Your kidneys are not filtering blood well enough (below a certain threshold on a standard kidney function test)
  • Your liver enzyme levels (AST or ALT) are 5 times or more above the normal range
  • You are currently taking antiviral medications to treat hepatitis C
  • You have another serious illness at the same time
  • You are taking any medication that could interact badly with doravirine
  • You are currently taking interferon, interleukins, other immune-based therapies, or chemotherapy
  • You are currently taking medication to prevent or treat an opportunistic infection (infections that occur when the immune system is weakened)
  • You have habits or conditions — such as heavy alcohol or drug use — that the trial doctor believes could make it hard to follow the trial rules or tolerate the treatment
  • You are under a form of legal protection due to reduced mental or physical capacity (this applies to French patients; confirm with trial site for equivalent situations in other countries)
  • You are currently taking part in another clinical trial that has a rule preventing you from joining additional trials
  • You are pregnant or breastfeeding

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 15 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: Christine Katlama, MD, Pitie-Salpetriere Hospital

Phone: 33142164181

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
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Registry
ClinicalTrials.gov
Start date
15 September 2020
Est. completion
30 October 2025

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Measure the virological efficacy at week 48 of once daily doravirine plus raltegravir dual therapy to assess the effectiveness of the dual therapy DORAL to maintain the virological success to W48

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: 15 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