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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001033 |
Purpose
PER 5/30/95 AMENDMENT: To compare the combined rate of failure during therapy and relapse after therapy between two durations of intermittent therapy (6 versus 9 months) for the treatment of pulmonary tuberculosis (TB) in HIV-infected patients. To compare toxicity, survival, and development of resistance in these two regimens.
ORIGINAL: To compare the efficacy and safety of induction and continuation therapies for the treatment of pulmonary TB in HIV-infected patients who are either from areas with known high rates of resistance to one or more anti-TB drugs or from areas where TB is expected to be susceptible to commonly used anti-TB drugs.
PER 5/30/95 AMENDMENT: In HIV-negative patients, intermittent anti-TB therapy has been shown to be as effective as daily therapy, but the optimal duration of therapy in HIV-infected patients has not been established.
ORIGINAL: In some areas of the country, resistance to one or more of the drugs commonly used to treat TB has emerged. Thus, the need to test regimens containing a new drug exists. Furthermore, the optimal duration of anti-TB therapy for HIV-infected patients with TB needs to be determined.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Tuberculosis |
Drug: Ethambutol hydrochloride Drug: Isoniazid Drug: Pyrazinamide Drug: Pyridoxine hydrochloride Drug: Levofloxacin Drug: Rifampin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | The Treatment of Pulmonary Mycobacterium Tuberculosis in HIV Infection |
| Estimated Enrollment: | 650 |
PER 5/30/95 AMENDMENT: In HIV-negative patients, intermittent anti-TB therapy has been shown to be as effective as daily therapy, but the optimal duration of therapy in HIV-infected patients has not been established.
ORIGINAL: In some areas of the country, resistance to one or more of the drugs commonly used to treat TB has emerged. Thus, the need to test regimens containing a new drug exists. Furthermore, the optimal duration of anti-TB therapy for HIV-infected patients with TB needs to be determined.
PER 5/30/95 AMENDMENT: Patients who have received an acceptable induction regimen prior to study entry and have been found to be susceptible to isoniazid and rifampin with no pyrazinamide resistance are randomized to receive either isoniazid or rifampin plus vitamin B6 biweekly for 18 or 31 weeks. Patients are evaluated at months 1, 2, 4, 6, 8, and 10, and every 4 months thereafter. Minimum follow-up is 1.5 years.
ORIGINAL: In the induction phase, patients enrolled in "drug-susceptible" areas (defined as metropolitan areas with a resistance rate for isoniazid therapy of less than 10 percent) receive four drugs: isoniazid (plus pyridoxine), rifampin, pyrazinamide, and ethambutol. Patients enrolled in "drug-resistant" areas (resistance rate for isoniazid of 10 percent or higher) receive the four-drug regimen with or without a fifth drug, levofloxacin. After 8 weeks of induction, patients with multi-drug resistance are removed from study regimens; all other patients enter a continuation phase. Pansusceptible patients (showing susceptibility to all first-line anti-TB drugs) receive two study drugs for an additional 18 or 31 weeks; patients with isoniazid-resistant (or intolerant) TB receive two or three study drugs for an additional 44 weeks, while those with rifampin-resistant TB receive two or three study drugs for an additional 70 weeks. Patients are evaluated every 2 weeks in the induction phase and every 12 weeks in the continuation phase. Minimum follow-up is 2 years.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
INDUCTION PHASE (ELIMINATED PER 5/30/95 AMENDMENT).
NOTE:
CONTINUATION PHASE.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Contacts and Locations
Show 46 Study Locations| Study Chair: | Perlman D | |
| Study Chair: | El-Sadr W |
More Information
| Study ID Numbers: | ACTG 222, CPCRA 019 |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001033 |
| Health Authority: | United States: Federal Government |
|
Isoniazid Tuberculosis, Pulmonary Pyrazinamide Pyridoxine Ofloxacin |
Rifampin AIDS-Related Opportunistic Infections Ethambutol Acquired Immunodeficiency Syndrome |
|
Bacterial Infections Opportunistic Infections Sexually Transmitted Diseases, Viral Ofloxacin Acquired Immunodeficiency Syndrome Pyrazinamide Vitamin B 6 Immunologic Deficiency Syndromes Virus Diseases Rifampin Gram-Positive Bacterial Infections |
HIV Infections Tuberculosis, pulmonary Tuberculosis, Pulmonary AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Mycobacterium Infections Ethambutol Pyridoxine Tuberculosis Retroviridae Infections Isoniazid |
|
Antimetabolites Anti-Infective Agents Communicable Diseases Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Infection Renal Agents Anti-Bacterial Agents Therapeutic Uses Vitamins Micronutrients Nucleic Acid Synthesis Inhibitors RNA Virus Infections |
Vitamin B Complex Immune System Diseases Antilipemic Agents Growth Substances Enzyme Inhibitors Anti-Infective Agents, Urinary Pharmacologic Actions Actinomycetales Infections Antibiotics, Antitubercular Lentivirus Infections Antitubercular Agents Fatty Acid Synthesis Inhibitors Leprostatic Agents |
