A Study for comparison of outcome of Immediate Versus Deferred Initiation of Antiretroviral Therapy for AIDS Disease-Free Survival in HIV-Infected Persons Treated for Tuberculosis when the CD4 count is less than 250 Cells/mm3

A Strategy Study of Immediate Versus Deferred Initiation of Antiretroviral Therapy for AIDS Disease-Free Survival in HIV-Infected Persons Treated for Tuberculosis with CD4 250 Cells/mm3

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000511

Enrollment

800

Registered

2009-11-23

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 Infection Tuberculosis

Interventions

Intervention1: Drug: Efavirenz,Drug: Emtricitabine,Drug: Emtricitabine/Tenofovir disoproxil fumarate,Drug: Tenofovir disoproxil fumarate,Drug: Rifampin: HIV Infections Tuberculosis Control Interventi

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: HIV-infected Confirmed or probable TB. More information on the criterion can be found in the protocol. Chest x-ray within 30 days prior to study entry Current rifampin- or other rifamycin-based TB treatment initiated within 14 days prior to study entry CD4 count less than 200 cells/mm3 within 30 days prior to study entry Willing to use acceptable methods of contraception while on study drugs and for 6 weeks after stopping these drugs Able to swallow oral medications Parent of guardian willing to provide informed consent, if applicable

Exclusion criteria

Exclusion criteria: Exclusion Criteria: ART for longer than 7 days prior to study entry or treatment for any period of time with two or more antiretrovirals in combination. Participants who have taken nevirapine or zidovudine during pregnancy are not excluded. Allergy or sensitivity to any of the study drugs or their formulations History of multidrug-resistant TB Receipt of any investigational therapy or chemotherapy within 30 days prior to study entry Certain medications Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the proportion of participants who have survived without AIDS progression by week 48 on the study Â·Timepoint: Assessment at 48 weeks or earlier if the primary end point is noted,	—

Secondary

Measure	Time frame
1.Determine safety and tolerability of ART in participants being treated for TB, assessed by the proportion of participants with Grade 3 or higher toxicities and the proportion of participants changing/discontinuing ART because of toxicities or treatment failure Â·Identify predictors of mortality and other AIDS-defining illnesses Timepoint: 1.time point during the 48 weeks of followup in the study	—

Measure

Time frame

1.Determine safety and tolerability of ART in participants being treated for TB, assessed by the proportion of participants with Grade 3 or higher toxicities and the proportion of participants changing/discontinuing ART because of toxicities or treatment failure Â·Identify predictors of mortality and other AIDS-defining illnesses Timepoint: 1.time point during the 48 weeks of followup in the study

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Countries

India, Thailand

Contacts

Public ContactDrSrikanthTripathy

ICMR

stripathy@nariindia.org91-20-27121343

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026