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Completed

NCT Number: NCT00164281

Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

This is a randomized, blinded, two-arm comparative trial of continued versus limited isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.

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Key information

Conditions

Tuberculosis Acquired Immunodeficiency Syndrome Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gaborone and Francistown Health Clinics

Gaborone, Botswana

About this study

Randomized, double blinded, two-arm comparative trial of continuous vs. limited isoniazid preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-infected
  • Age >=18 years
  • Tuberculin skin test positive or negative
  • Laboratory:
  • Hemoglobin (Hgb) >6.5 gm/dl;
  • Neutrophil count >1,000 cells/mm3;
  • Platelets >75,000/mm3;
  • AST (SGOT) <122 U/L;
  • Creatinine <1.5 mg/dl;
  • Beta HCG = negative
  • Karnofsky performance status >=60
  • Signed informed consent

Exclusion criteria

  • History of TB in the last 3 years or current active TB
  • History of noncompliance to chronic therapies

Treatment and study plan

Isoniazid

Drug

Daily 300 mg isoniazid supplemented with 25 mg pyridoxine for 6 months vs 36 months.

Other names: Isonicotinic Acid Hydrazide

Primary outcomes

  1. Number of Participants With Incident Tuberculosis

    Time frame: During follow-up (36 months)

    Incident tuberculosis during follow-up. Tuberculosis cases were categorized as:

    Definite: ≥1 positive culture for M. tuberculosis or ≥2 sputum smears positive for acid-fast bacilli; Probable: 1 sputum smear or biopsy specimen positive for acid-fast bacilli; Possible: clinical diagnosis with negative or unavailable smear/culture results.

    Outcome data include definite, probable, and possible tuberculosis cases combined, consistent with the published analysis.

Secondary outcomes

  1. Number of Participants Who Died

    Time frame: During follow-up (36 months)

    All-cause mortality during the 36-month follow-up period.

  2. Tuberculosis and Death Composite Outcome

    Time frame: During follow-up (36 months)

    Composite of incident tuberculosis and all deaths during the 36-month follow-up period. The paper presents this as "Tuberculosis and all deaths."

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • Botswana Ministry of Health
  • United States Agency for International Development (USAID)

Registry information

Official study title

A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

Important dates

Study start
2004
Primary completion
2009
Study completion
2011
First posted
Sep 14, 2005
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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