CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed
Drug / intervention
Ethambutol hydrochloride +5 moredrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00001033
NCT00001033Phase 3Completed

The Treatment of Pulmonary Mycobacterium Tuberculosis in HIV Infection

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 31, 2001·Updated Nov 4, 2021

In Brief

A Phase 3 clinical trial evaluating Ethambutol hydrochloride, Isoniazid, and 4 other interventions for HIV Infections and Tuberculosis. Completed, across 12 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2001
Study CompletionJul 1, 1997
TodayJul 2, 2026
Posted 24.8 years ago

Interventions

Ethambutol hydrochloridedrug

Isoniaziddrug

Pyrazinamidedrug

Pyridoxine hydrochloridedrug

Levofloxacindrug

Rifampindrug