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Early vs Late Introduction of Antiretroviral Therapy in HIV-infected Patients With Tuberculosis (ANRS 1295 CAMELIA)

NCT00226434 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 661

Last updated 2012-03-16

No results posted yet for this study

Summary

In Cambodia the prevalence of both tuberculosis (TB) and Human Immunodeficiency Virus (HIV) infection is high. Data suggest that aggressive management of HIV infection, which includes Anti-Retroviral Therapy (HAART) during treatment of TB, decreases both morbidity and mortality. On the other hand, the use of HAART for patients with TB may cause severe complications due to drug-drug interactions, and occasionally a temporary exacerbation of symptoms. These reactions may be particularly severe when HAART is started soon after the start of TB treatment.

The proposed study aims to determine the optimal time to initiate HAART in previously untreated HIV-infected adult patients with TB and low CD4 cell counts.

Conditions

Interventions

PROCEDURE

Early antiretroviral treatment

The ARV treatment is started 2 weeks after the diagnosis and the start of the anti-tuberculosis treatment

PROCEDURE

Late antiretroviral treatment

The ARV treatment is started 8 weeks after the diagnosis and the start of the anti-tuberculosis treatment

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • François-Xavier Blanc · Bicêtre University Hospital, France

  • Thim Sok · Cambodian Health Committee, Phnom Penh, Cambodia

  • Anne Goldfeld · Institute for Biomedical Research, Boston, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Cambodia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00226434 on ClinicalTrials.gov