NCT01380080

REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 851 (actual)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a randomized, open-label, phase IV strategy trial for participants from resource-limited settings (RLS) who presented with advanced HIV disease and no probable or confirmed tuberculosis (TB), and who were initiating antiretroviral treatment (ART). Participants were randomized to one of two strategy arms: immediate, empiric TB treatment (Empiric arm) or local standard of care TB treatment (IPT arm). Randomization was balanced by clinical trial unit and stratified according to CD4+ T cell count (\<25 vs. ≥25 cells/mm\^3) and presence of any of the following prognostic factors: reportable hospitalization within the past 30 days, BMI \<18.5 kg/m\^2, or anemia (hemoglobin \<8 g/dl). Participants were followed for 96 weeks. Participants attended study visits at screening, enrollment, and weeks 1, 2, 4, 8, 12, 16, 20, 24 and 48. Signs and symptoms, ART modifications, concomitant medications, and clinical events as defined by AIDS Clinical Trials Group (ACTG) Appendix 60 were collected at each visit. Blood was collected for CD4 and HIV-1 RNA at study entry, weeks 4, 24 and 48, and blood for safety laboratories (liver function, hematology, and renal function) was collected at all visits except week 1. A sputum sample was collected and stored at study entry. Phone contact was conducted at weeks 60, 72, 84 and 96 to obtain information about vital status, reportable hospitalization, TB status (including screening and follow-up), TB and HIV treatment modifications, and quality of life.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	Atripla (r)	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.
DRUG	Efavirenz	Participants will take one 600 mg tablet administered orally once daily without food.
DRUG	Truvada	Participants will take one tablet of Emtricitabine 200mg/tenofovir disoproxil fumarate 300mg (FTC/TDF, Truvada) administered orally once daily with or without food.
DRUG	Rifampin/isoniazid/pyrazinamide/ethambutol FDC	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.
DRUG	Rifampin/isoniazid FDC	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.
DRUG	Isoniazid	INH 300 mg orally once daily

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-01-31
• Completion: 2016-04-01
• First posted: 2011-06-27
• Last updated: 2024-10-15
• Results posted: 2016-02-23

Locations

18 sites across 10 countries: Brazil, Haiti, India, Kenya, Malawi, Peru, South Africa, Uganda, Zambia, Zimbabwe