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Tuberculosis Prevention for HIV Infected Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00057122
Recruitment Status : Completed
First Posted : March 28, 2003
Last Update Posted : October 22, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Tuberculosis Drug: Isoniazid Drug: Rifapentine Drug: Rifampin Phase 3

Detailed Description:

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 Design

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
Primary Completion Date : November 2008
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Development of confirmed, probable, or possible active pulmonary or extrapulmonary tuberculosis (TB) [ Time Frame: 6/2008 ]

Secondary Outcome Measures :
  1. Risk of TB and death [ Time Frame: 6/2008 ]
  2. rates of adherence, adverse reactions and treatment discontinuation [ Time Frame: 6/2008 ]
  3. patterns of antibiotic resistance [ Time Frame: 6/2008 ]
  4. clinical and epidemiological factors associated with developing TB [ Time Frame: 6/2008 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infected
  • Tuberculin test (PPD) positive 5 mm or greater
  • Chest x-ray negative for pulmonary tuberculosis

Exclusion Criteria:

  • Pregnant or breastfeeding
Contacts and Locations

Information from the National Library of Medicine

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


Locations
South Africa
Chris Hani Baragwanath Hospital
Soweto, South Africa
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Richard Chaisson, MD Johns Hopkins Medical Institute
More Information

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