Phase 4 HIV and AIDS Trial, Recruiting NCT05630638 Sponsor: University of Liverpool Condition: HIV and AIDS
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Phase 4 HIV and AIDS Trial, Recruiting

NCT05630638
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:

  • Women aged 18 or older
  • People who are able to give their consent to participate before the trial begins
  • People who are willing and able to follow all the requirements of the study
  • People who are living with HIV
  • People who are pregnant and starting combination HIV treatment (cART) between 12 and 26 weeks of pregnancy
  • People who plan to breastfeed after giving birth

Who may not be able to join:

  • People who have received combination HIV treatment (cART) at any point in the 6 months before joining
  • People who have chronic hepatitis B infection along with signs of liver inflammation affecting certain liver enzymes
  • People whose liver enzyme levels (ALT) are significantly above the normal range, or whose liver enzyme and bilirubin levels are both elevated at certain thresholds (confirm with trial site)
  • People who have previously had a documented treatment failure with a type of HIV medication called an NNRTI
  • People who have had an allergic reaction to any HIV medication in the past
  • People who are taking certain other medications that can interfere with how the study drugs are processed by the body — for example, rifampicin, some anti-seizure medications, rifabutin, St John's Wort, mitotane, enzalutamide, or lumacaftor (confirm with trial site for the full list)
  • People with certain rare inherited conditions affecting how the body processes sugars — specifically galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption — as one of the study drugs contains lactose
  • People who have clinical depression or where a doctor has assessed there may be an increased risk of suicidal thoughts

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 12 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: Saye Khoo, University of Liverpool

Phone: + 44 151 794 5553

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
University of Liverpool
Registry
ClinicalTrials.gov
Start date
10 October 2023
Est. completion
1 July 2028

Where this trial is recruiting

🇿🇦 South Africa

Primary endpoints

AUC of doravirine in pregnant women; Cmax of doravirine in pregnant women; Cmin of doravirine in pregnant women; CL/F of doravirine in pregnant women

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: 12 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