Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
|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: NCT00164281|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis HIV Infections||Drug: Isoniazid||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||May 2011|
Experimental: Continuous vs limited isoniazid
The placebo arm will receive 6 months of open label isoniazid before beginning placebo (as a coded medication). The treatment (experimental arm) will receive 6 months of open label isoniazid before beginning coded medication (isoniazid).
Daily 300 mg isoniazid supplemented with 25 mg pyridoxine for 6 months vs 36 months.
Other Name: Isonicotinic Acid Hydrazide
- Incident tuberculosis [ Time Frame: During enrolment ]
- Death [ Time Frame: During enrolment ]
- Adverse events [ Time Frame: During provision of study medication ]After enrolment, half of the participants will receive isoniazid for 6 months and the other half for 36 months.
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): NCT00164281
|Gaborone and Francistown Health Clinics|
|Gaborone and Francistown, Botswana|
|Principal Investigator:||Taraz Samandari, MD, PHD||Centers for Disease Control and Prevention|