Status:
COMPLETED
Early vs Late Introduction of Antiretroviral Therapy in HIV-infected Patients With Tuberculosis (ANRS 1295 CAMELIA)
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
HIV Infection
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
In Cambodia the prevalence of both tuberculosis (TB) and Human Immunodeficiency Virus (HIV) infection is high. In 2000, there were approximately 75.000 newly diagnosed TB cases. In 2003, 1.9% of the p...
Eligibility Criteria
Inclusion
- Age 18 or over
- Positive HIV test result
- CD4+ cell count under or equal to 200 cells per ml within 14 days prior the study entry
- Positive AFB on any smear (sputum, lymph node drainage, stool, CSF, pleural fluid)
- Naive to ART
- TB treatment started less than one week prior enrolment
- Negative gonadotrophin pregnancy test (blood) for women of childbearing potential (i.e. not surgically sterile or less than 2 years menopause)
- Agreement from female candidates who are participating in sexual activity that could lead to pregnancy while receiving and for 6 weeks after stopping efavirenz to use two reliable methods of contraception, one of which including condom.
Exclusion
- Suspected TB with negative AFB
- Pregnant or breastfeeding women
- Impaired hepatic function (icterus, elevated AST or ALT at least 5 times over the normal value)
- Unable and/or unlikely to comprehend and/or be adherent to the protocol
- Treated for a previous suspected or documented TB other than the ongoing infection which motivates enrolment in this trial
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
661 Patients enrolled
Trial Details
Trial ID
NCT00226434
Start Date
January 1 2006
End Date
May 1 2010
Last Update
March 16 2012
Active Locations (5)
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1
Calmette Hospital
Phnom Penh, Cambodia
2
Khmero-Soviet Friendship Hospital
Phnom Penh, Cambodia
3
Siem Reap Referral Hospital
Siem Reap, Cambodia
4
Provincial hospital
Svay Rieng, Cambodia