Skip to content

A study to compare early vs delayed treatment for HIV in patients with HIV and tuberculosis

Study of early versus delayed initiation of antiretroviral therapy for Indian HIV-infected patients with tuberculosis on antituberculosis chemotherapy in Indian subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/12/002260
Enrollment
150
Registered
2011-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- HIV & TB

Interventions

Intervention1: Early intiation of HAART: HAART starting within 2-4 weeks of commencement of antituberculosis treatment (ATT) for 12 months Intervention2: Early intiation of ART: ART starting within 2-

Sponsors

National AIDS Control Organization
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects aged over 18 years, who had seven or fewer days of cumulative previous ART (unless taken during pregnancy to prevent mother-to-child-transmission), and who had not started ATT or received less than 14 days of the same, were eligible for entry into this study. Both confirmed and probable diagnoses of TB were permitted for inclusion.

Exclusion criteria

Exclusion criteria: Exclusion criteria were pregnancy, concomitant diabetes mellitus, epilepsy, severe illness (e.g. loss of consciousness, severe hempotysis etc.), and multi-drug resistant TB (MDR - TB).

Design outcomes

Primary

MeasureTime frame
The primary end points of the study were death from any cause and antiretroviral treatment failure, as a measure of progression of HIV disease.Timepoint: April, 2006 to March 2011

Secondary

MeasureTime frame
The secondary end points of the study were defined by safety and tolerability of ARV therapy, as assessed by the incidence of adverse events and proportion of subjects changing/ discontinuing ARV therapy because of the same.Timepoint: April, 2006 to March 2011

Countries

India

Contacts

Public ContactDr Sanjeev Sinha

AIIMS

sanjusinha@hotmail.com26594440

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 25, 2026