Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
4 other identifiers
interventional
2,000
1 country
25
Brief Summary
To evaluate and compare the effectiveness of a 2-month regimen of rifampin and pyrazinamide versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb). Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
October 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 2, 2021
October 1, 2021
November 2, 1999
October 26, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Antiretroviral treatment.
- Pneumocystis carinii pneumonia prophylaxis.
- Treatment for acute opportunistic infection/malignancy.
- Aminoglycosides, quinolones or fluoroquinolones such as ciprofloxacin or ofloxacin for \< 14 days for treatment of intercurrent infection.
- Patients must have:
- HIV infection.
- Signed informed consent.
- Reasonably good health at time of study entry.
- Perceived life expectancy of at least six months.
- Allowed:
- Participation in other clinical trials as long as there is no potential activity of other study drugs against Mycobacterium tuberculosis (MTb), additive toxicities between study agents, or known possible drug interactions between study drugs.
- Prior Medication:
- Allowed:
- +1 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Current active tuberculosis (confirmed or suspected).
- Sensitivity or intolerance to study medication.
- Acute hepatitis.
- Evidence of peripheral neuropathy, i.e., signs or symptoms of paresis, paresthesias, neuromotor abnormalities, or neurosensory deficits of grade 3 or worse.
- Inability to have concomitant medications changed to avoid serious interaction with study drug.
- Concurrent Medication:
- Excluded:
- Quinolones, fluoroquinolones, or aminoglycosides with antituberculous activity (may be used for up to 14 days for treatment of intercurrent infection).Other agents with known or potential antituberculous activity should be avoided, including the following:
- Aminosalicylic acid salts, capreomycin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid, kanamycin, pyrazinamide, rifabutin, rifampin, streptomycin, and thiacetazone.
- Prior Medication:
- Excluded:
- History of treatment for \> 2 months with agents that have known or potential antituberculous activity other than those specifically allowed.
- Agents with potential or known antituberculous activity include the following:
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Community Consortium / UCSF
San Francisco, California, 94110, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507, United States
Hill Health Corp
New Haven, Connecticut, 06519, United States
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899, United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Chicago Dept of Health / Speciality STD Clinic
Chicago, Illinois, 60605, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112, United States
Johns Hopkins Univ / Brazil
Baltimore, Maryland, 21205, United States
Johns Hopkins Univ / School of Hygiene & Public Health
Baltimore, Maryland, 21205, United States
Boston Dept of Health and Hosps
Boston, Massachusetts, 02118, United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103, United States
Saint Michael's Med Ctr
Newark, New Jersey, 07102, United States
Lattimore Comprehensive Pulmonary Disease Clinic
Newark, New Jersey, 07103, United States
North Jersey Community Research Initiative
Newark, New Jersey, 07103, United States
Addiction Research and Treatment Corp
Brooklyn, New York, 11201, United States
Clinical Directors Network of Region II
New York, New York, 10011, United States
Beth Israel Med Ctr
New York, New York, 10035, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10456, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
Richmond AIDS Consortium
Richmond, Virginia, 23298, United States
Related Publications (3)
Gordin F, Matts J, Miller C, Chaisson R, Garcia M, O'Brien R. Risk factors for developing active tuberculosis (TB) among HIV-infected, PPD-positive (+) patients (pts). Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:151 (abstract no 448)
BACKGROUNDNew TB guidelines for persons with HIV. AIDS Treat News. 1998 Nov 6;(No 306):6.
PMID: 11365963BACKGROUNDGordin F, Chaisson RE, Matts JP, Miller C, de Lourdes Garcia M, Hafner R, Valdespino JL, Coberly J, Schechter M, Klukowicz AJ, Barry MA, O'Brien RJ. Rifampin and pyrazinamide vs isoniazid for prevention of tuberculosis in HIV-infected persons: an international randomized trial. Terry Beirn Community Programs for Clinical Research on AIDS, the Adult AIDS Clinical Trials Group, the Pan American Health Organization, and the Centers for Disease Control and Prevention Study Group. JAMA. 2000 Mar 15;283(11):1445-50. doi: 10.1001/jama.283.11.1445.
PMID: 10732934BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gordin F
- STUDY CHAIR
Brown LS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
October 1, 1997
Last Updated
November 2, 2021
Record last verified: 2021-10