Tuberculosis Prevention for HIV Infected Adults
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Tuberculosis
Intervention: Isoniazid (Drug); Rifapentine (Drug); Rifampin (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Official(s) and/or principal investigator(s):
Richard Chaisson, MD, Principal Investigator, Affiliation: Johns Hopkins Medical Institute
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.
Official title: Novel TB Prevention Regimens for HIV-Infected Adults
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Development of confirmed, probable, or possible active pulmonary or extrapulmonary tuberculosis (TB)
Risk of TB and death
rates of adherence, adverse reactions and treatment discontinuation
patterns of antibiotic resistance
clinical and epidemiological factors associated with developing TB
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.
Minimum age: 18 Years.
Maximum age: N/A.
- HIV infected
- Tuberculin test (PPD) positive 5 mm or greater
- Chest x-ray negative for pulmonary tuberculosis
- Pregnant or breastfeeding
Locations and Contacts
Chris Hani Baragwanath Hospital, Soweto, South Africa
Click here for more information on rifampin
Click here for more information on isoniazid
Starting date: September 2002
Ending date: June 2009
Last updated: May 28, 2008