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Tuberculosis Prevention for HIV Infected Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Chaisson, National Institute of Allergy and Infectious Disease (NIAID)
ClinicalTrials.gov Identifier:
NCT00057122
First received: March 27, 2003
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
HIV Infections
Tuberculosis
Drug: Isoniazid
Drug: Rifapentine
Drug: Rifampin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Novel TB Prevention Regimens for HIV-Infected Adults

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Development of confirmed, probable, or possible active pulmonary or extrapulmonary tuberculosis (TB) [ Time Frame: 6/2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Risk of TB and death [ Time Frame: 6/2008 ] [ Designated as safety issue: No ]
  • rates of adherence, adverse reactions and treatment discontinuation [ Time Frame: 6/2008 ] [ Designated as safety issue: No ]
  • patterns of antibiotic resistance [ Time Frame: 6/2008 ] [ Designated as safety issue: No ]
  • clinical and epidemiological factors associated with developing TB [ Time Frame: 6/2008 ] [ Designated as safety issue: No ]

Enrollment: 1148
Study Start Date: September 2002
Study Completion Date: June 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057122

Locations
South Africa
Chris Hani Baragwanath Hospital
Soweto, South Africa
Sponsors and Collaborators
Investigators
Principal Investigator: Richard Chaisson, MD Johns Hopkins Medical Institute
  More Information

Additional Information:
No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)

Additional 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: 1R01AI48526-01A1, 5RO1AI048526-02
Study First Received: March 27, 2003
Last Updated: October 19, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Preventive therapy

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mycobacterium Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Rifapentine
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014