Double blind, placebo-controlled, randomised clinical trial to evaluate the efficacy of co-trimoxazole given as prophylaxis in reducing mortality in human immunodeficiency virus-infected adults with tuberculosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15281875

Enrollment

1045

Registered

2006-05-11

Start date

2000-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis and HIV/AIDS Infections and Infestations Tuberculosis

Interventions

Patients are randomised to receive 960 mg co-trimoxazole daily versus placebo.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults greater than 16 years old 2. HIV-infected 3. Newly diagnosed pulmonary tuberculosis 4. Had a permanent residential address 5. Not pregnant 6. Willing to give informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant 2. Terminally ill World Health Organization (WHO) stage 4 patients 3. History of sulfonamide allergy 4. Already receiving co-trimoxazole

Design outcomes

Primary

Measure	Time frame
1. All cause mortality 2. Adverse events leading to interruption of trial drug	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

Zambia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 5, 2026