CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 851 enrolled
Drug / intervention
Atripla (r) +5 moredrug
Likely dose
Atripla (r) 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01380080
NCT01380080Phase 4Completed

Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens (REMEMBER)

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Jun 27, 2011·Updated Oct 15, 2024

In Brief

A Phase 4 clinical trial evaluating Atripla (r), Efavirenz, and 4 other interventions for HIV Infection. Completed, enrolled 851 participants across 18 sites in 10 countries.

Detailed Summary

People with HIV have a high chance of becoming infected with TB, especially when they live in areas where TB infection is common. It can be difficult to diagnose TB in people who need to start HIV treatment right away. Within about 6 months after starting HIV treatment, some of these people can become very sick with TB and can even die from it. This study was being done in people who were starting HIV treatment and who lived in areas where the TB infection rate is high. The purpose of this study was to test an experimental approach to TB treatment to see if it is better than the usual approach. The experimental approach was to start TB treatment at the same time as HIV treatment, even when TB infection had not been found. The usual approach was to start TB treatment only if TB infection was found. In this study, half of the people started TB treatment at the same time as they started their HIV treatment. The other half started TB treatment only if TB infection was found. The study also tested how safe and effective it was to start TB treatment at about the same time as HIV treatment even when TB infection had not been found. The study collected information about diet, whether (and when) people in the study became sicker or died, how well their HIV was controlled, how they were feeling, how they were taking their medications, whether it mattered where they lived or what kind of HIV and TB care was standard, how many people were diagnosed with TB while in the study, and how the cost of the two treatment options on a national level could be compared.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
CountriesBrazil, Haiti, India, Kenya, Malawi, Peru, South Africa, Uganda, Zambia, Zimbabwe

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 27, 2011
Enrollment StartOct 1, 2011
Primary CompletionJan 31, 2015
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.0 years ago

Interventions

Atripla (r)drug

Patients are administered one tablet of Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (EFV/FTC/TDF, Atripla) to taken be taken orally once daily at bedtime without food.

Efavirenzdrug

Participants will take one 600 mg tablet administered orally once daily without food.

Truvadadrug

Participants will take one tablet of Emtricitabine 200mg/tenofovir disoproxil fumarate 300mg (FTC/TDF, Truvada) administered orally once daily with or without food.

Rifampin/isoniazid/pyrazinamide/ethambutol FDCdrug

Participants will be administered Rifampin/isoniazid/pyrazinamide/ethambutol FDC tablets orally, once daily; dose by weight as determined in Table 5.1-1 of the protocol, for the first 8 weeks.

Rifampin/isoniazid FDCdrug

Participants will be administered rifampin/isoniazid FDC tablets orally, once daily; dose by weight as determined in Table 5.1-1 in the protocol, for 16 weeks following the first 8 weeks.

Isoniaziddrug

INH 300 mg orally once daily