CompletedPhase 4

Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa

South Africa110 participantsStarted 2021-11-17

Plain-language summary

The study investigators are conducting an observational, parallel group pharmacokinetic (PK) study among women living with HIV (WLHIV) already on 1st line antiretroviral therapy (ART) and virally suppressed, 18-45 years old (inclusive), to evaluate any bidirectional drug-drug interactions (DDIs) between doravirine (DOR)-containing ART and hormonal contraceptive methods. This PK study will enroll women in five distinct groups, each with 21 participants (total of 105 participants), and follow them for approximately 18-30 weeks.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Haemoglobin abnormality Grade 2 or higher
✕. Calculated creatinine clearance less than 50 mL/min by the Schwartz Equation
✕. relocate away from the study site
✕. travel away from the study site for a time period that would interfere with product resupply and study participation
✕. Known adverse reaction to any of the study products (ever),
✕. Participation in any other research study involving drugs, medical devices or vaccines within 60 days of enrollment,
✕. At Enrollment, as determined by the PI/designee, has any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder, metabolic bone disease or infectious disease,

What they're measuring

Hormonal Contraceptive Concentrations

Timeframe: at 2,4,8,12 weeks for IM DMPA and SC MPA or 2,4,8,12,20,24 weeks for ETG implants and IUD groups after contraceptive method initiation

DOR Concentrations

Timeframe: at 2,4,8,12 weeks for IM and SC DMPA or 2,4,8,12,20,24 weeks for ETG implants and IUD groups after contraceptive method initiation

Trial details

NCT IDNCT04669678

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-05

Results submitted2025-01-21

View on ClinicalTrials.gov More HIV Infections trials