Tuberculosis Prevention for HIV Infected Adults
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ClinicalTrials.gov Identifier: NCT00057122 |
Recruitment Status
:
Completed
First Posted
: March 28, 2003
Last Update Posted
: October 22, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Tuberculosis | Drug: Isoniazid Drug: Rifapentine Drug: Rifampin | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1148 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Novel TB Prevention Regimens for HIV-Infected Adults |
Study Start Date : | September 2002 |
Actual Primary Completion Date : | November 2008 |
Actual Study Completion Date : | June 2009 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 1 |
Drug: Isoniazid
300mg
Drug: Rifapentine
Rifapentine 900 mg
|
Active Comparator: 2 |
Drug: Isoniazid
300mg
Drug: Rifampin
Rifampin 600 mg
|
Active Comparator: 3 |
Drug: Isoniazid
300mg
|
Active Comparator: 4 |
Drug: Isoniazid
300mg
|
- Development of confirmed, probable, or possible active pulmonary or extrapulmonary tuberculosis (TB) [ Time Frame: 6/2008 ]
- Risk of TB and death [ Time Frame: 6/2008 ]
- rates of adherence, adverse reactions and treatment discontinuation [ Time Frame: 6/2008 ]
- patterns of antibiotic resistance [ Time Frame: 6/2008 ]
- clinical and epidemiological factors associated with developing TB [ Time Frame: 6/2008 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV infected
- Tuberculin test (PPD) positive 5 mm or greater
- Chest x-ray negative for pulmonary tuberculosis
Exclusion Criteria:
- Pregnant or breastfeeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057122
South Africa | |
Chris Hani Baragwanath Hospital | |
Soweto, South Africa |
Principal Investigator: | Richard Chaisson, MD | Johns Hopkins Medical Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Richard Chaisson, Director, Center for TB Research, National Institute of Allergy and Infectious Disease (NIAID) |
ClinicalTrials.gov Identifier: | NCT00057122 History of Changes |
Other Study ID Numbers: |
1R01AI048526-01A1 ( U.S. NIH Grant/Contract ) 5R01AI048526-02 ( U.S. NIH Grant/Contract ) |
First Posted: | March 28, 2003 Key Record Dates |
Last Update Posted: | October 22, 2012 |
Last Verified: | October 2012 |
Keywords provided by Richard Chaisson, National Institute of Allergy and Infectious Disease (NIAID):
Preventive therapy |
Additional relevant MeSH terms:
HIV Infections Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Rifampin |
Rifapentine Isoniazid Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers |