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

P2005: A Phase I/II Open-Label, Single-Arm Study to Evaluate...

The study is designed to characterize the pharmacokinetics of DLM using a model-based approach, and to evaluate safety and...

Read More

A5207, Maintaining Options for Mothers Study (MOMS): A Phase...

A major disadvantage of giving SD NVP is the potential for maternal development of NVP resistance and additional resistance to...

Read More

P1108: A Phase I/II, Open-Label, Single Arm Study to...

This purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of bedaquiline (BDQ) in...

Read More

A5361s: Pitavastatin to REduce Physical Function Impairment...

A5361s is a prospective study to determine the effects of pitavastatin on physical function. The study will enroll participants...

Read More

NWCS 445: Novel Biomarkers to Shorten TB Treatment

Objectives: Primary: To develop a highly predictive algorithm that identifies TB patients who will be cured by treatment...

Read More