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Clinical Evaluation of Adjusted Doses of Darunavir/Ritonavir With Rifampicin in HIV-infected Volunteers

NCT03892161 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-04-03

No results posted yet for this study

Summary

The DaRifi study aims:

1. Develop adjusted doses of darunavir/ritonavir for use in HIV-infected patients requiring co-treatment of TB with a rifampicin-based regimen.
2. Compare the steady state pharmacokinetics of doubled doses of DRV/r with rifampicin (in once daily and 12-hourly approaches) to standard daily doses without rifampicin.
3. Twenty-eight volunteers will be enrolled for a target of 24 participants completing the study.

Conditions

  • HIV Infections

Interventions

DRUG

Darunavir/ritonavir 800/100 mg tablet

Standard dose DRV/r administered

DRUG

Rifampicin 600mg QD tablet and DTG 50mg BD

Rifampicin and DTG added

Sponsors & Collaborators

  • Wits Reproductive Health and HIV Institute

    collaborator OTHER

  • Desmond Tutu HIV Centre

    collaborator OTHER

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Helen McIlleron, PhD · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-12
Primary Completion
2018-11-22
Completion
2018-11-22

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03892161 on ClinicalTrials.gov