A5274: REMEMBER, Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens

Study Location:

India

Topic:

HIVTuberculosis and HIV

Clinicaltrials.gov Link:

https://clinicaltrials.gov/ct2/show/NCT01380080?term=A5274&rank=1

IRB#:

NA_00065975

Coordinator:

Nishi Suryavanshi

Enrollment:

Closed

Trial Period:

Completed

This study is being done in people who are starting HIV treatment and who live in areas where the TB infection rate is high. The purpose of this study is to test an experimental approach to TB treatment to see if it is better than the usual approach. The experimental approach is to start TB treatment at the same time as HIV treatment, even when TB infection has not been found. The usual approach is to start TB treatment only if TB infection is found.

In this study, half of the people will start TB treatment at the same time as they start their HIV treatment. The other half will start TB treatment only if TB infection is found.

The study will also test how safe and effective it is to start TB treatment at about the same time as HIV treatment even when TB infection has not been found. The study will collect information about diet, whether (and when) people in the study become sicker or die, how well their HIV is controlled, how they are feeling, how they are taking their medications, whether it matters where they live or what kind of HIV and TB care is standard, how many people are diagnosed with TB while in the study, and how the cost of the two treatment options on a national level could be compared.

Participating sites must have a regional TB incidence (i.e., the TB incidence within the site’s expected catchment area) of more than 100 cases/100,000 population per year, a national ART program, and documented high mortality rates among HIV-infected individuals (i.e., at least 5% overall at 6 months post ART initiation). Sites whose regional TB incidence or mortality rates approach but do not meet the requirements stated above may be approved on a case-by-case basis by the study team, following a review of all relevant information. Participants with probable or confirmed TB at screening will be excluded.

Categories

Location
Topic

Clinical Trials

A5282: A Randomized, Phase II Trial to Compare an HPV...

The investigators are looking for a better way to prevent cervical cancer. This study is comparing two different methods to...

Read More

A5279, Phase III Clinical Trial of Ultra-Short-Course...

This study will enroll HIV-infected people who do not have evidence of active TB but who are at high risk of developing active...

Read More

P1077FF: Formula Feeding Version of the PROMISE Study...

1077FF is a randomized strategy trial, which is part of the PROMISE studies (1077BF, 1077FF, P1084s, and 1077HS). The Promoting...

Read More

HPTN 069: A Phase II Randomized, Double-Blind, Study of the...

HPTN 069 is a phase II, four-arm, multisite, randomized, double-blinded trial. To assess the safety and tolerability of four...

Read More

A5349: Rifapentine-containing treatment shortening regimens...

The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a...

Read More