Pharmacokinetics of Efavirenz in the Presence of Rifampicin and Isoniazid

PHASE1UnknownINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

November 21, 2016

Primary Completion Date

January 31, 2018

Study Completion Date

February 28, 2018

Conditions
HIV
Interventions
DRUG

Efavirenz

Efavirenz 400mg

DRUG

tenofovir /emtricitabine

tenofovir 245 mg/emtricitabine 200mg

DRUG

tenofovir/lamivudine

tenofovir 245mg/lamivudine 300mg

DRUG

lamivudine/zidovudine

lamivudine 300mg/zidovudine 600mg

DRUG

Rifinah or local generics

Rifampicin 600 mg and isoniazid 300 mg if ≥50kg or rifampicin 450 mg and isoniazid 300 mg if \<50kg.)

Trial Locations (2)

Unknown

NOT_YET_RECRUITING

Infectious Diseases Insitute, Kampala

SW10 9NH

RECRUITING

Chelsea and Westminster Hospital NHS Foundation Trust, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mylan Inc.

INDUSTRY

collaborator

United States Agency for International Development (USAID)

FED

lead

St Stephens Aids Trust

OTHER