HIV Infections Clinical Trial
Official title:
Novel TB Prevention Regimens for HIV-Infected Adults
This study compares three different tuberculosis (TB) prevention regimens against the standard regimen of 6 months of isoniazid. It is being conducted in Soweto, South Africa. People who are HIV positive and have a positive tuberculin skin test without signs of active tuberculosis may join.
AIDS is the leading cause of death in sub-Saharan Africa, and TB is the leading cause of
death in patients with AIDS on that continent. Preventive therapy for HIV infected people
with latent TB infection is important to reduce the risk of progression to active TB.
Although preventive TB therapy is generally recommended throughout the Western world for
people with HIV, it is not routinely advocated or provided to patients in developing
countries. Six months of self-supervised INH is the gold standard of preventive TB therapy.
Newer preventive regimens with a shorter duration of treatment and intermittent dosing could
improve compliance and permit treatment supervision through dosing observation. This study
will compare the standard INH regimen with two new regimens: rifapentine and INH observed
once weekly for 12 weeks and rifampin and INH observed twice weekly for 12 weeks.
Patients will be interviewed to identify risk factors for TB and symptoms of active TB. A
physical examination and chest radiograph will be performed on all potential patients to
identify and exclude all active TB cases (these patients will be referred for appropriate
treatment of their infection).
Patients who meet the inclusion criteria will be randomized to one of the following
treatment arms: rifapentine/INH for 12 weeks, observed weekly; rifampin/INH for 12 weeks,
observed twice weekly; INH for 6 months, self-supervised; or continuous INH,
self-supervised. Patients randomized to the two self-administered INH arms will be given a 1
month supply of INH and instructed to take one pill each day. Patients in the continuous INH
arm will take INH continuously until the end of the study. Depending on when the patient
enrolls in the study, the patient could take INH for 1 to 4 years. Each patient will be
provided with education on the need to adhere to the protocol and information on potential
study drug related toxicity. All patients will be given their first dose of study medication
during the enrollment period. Patients in the shorter-course, observed regimens will be
given each of their doses in a clinic under the supervision of a study nurse.
At each study encounter, possible toxicity will be assessed via interview. Patients will be
followed every 6 months after the completion of preventive therapy until the study closes.
Outreach workers will perform home visits to encourage follow-up and determine vital status
for any patient who has missed a scheduled follow-up visit. Patients with evidence of active
tuberculosis at any follow-up visit will be evaluated and treated appropriately. Patients
will be offered a small incentive for fulfilling study requirements. The equivalent of $5
(30 rand) will be paid after successful entry into the trial and at each 6 month visit as
compensation for time spent in the study and to cover travel expenses.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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