Status:
COMPLETED
Simple Once Daily Triple Regimen Including Tenofovir, Emtricitabine and Efavirenz in HIV-1 Infected Patients (ANRS 1207)
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Gilead Sciences
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In the context of Sub-saharian Africa, this trial evaluate one of the most simple treatment available for HIV-1 infected patients. The combination proposed is a triple antiretroviral therapy with only...
Eligibility Criteria
Inclusion
- Documented infection with HIV-1 (ELISA- Western Blot)
- Outpatient of masculine or feminine gender
- In female patients any risk of pregnancy must be avoid: women at least 1 year past menopause or being confirmed sterile or having an effective contraceptive device
- No previous treatment with antiretroviral therapy
- CDC group C (except tuberculosis if CD4 count is over 350 /ml), CDC group B with CD4+ count under 350/ml and CDC group A with CD4 count under 200/ml.
- Patient has provided informed written consent
- Patient must agree not to take any concomitant medication throughout the duration of the study without first informing the investigator
Exclusion
- Deficiency of the patient rendering participation in the study or understanding of the information imparted difficult or even impossible
- Patient participating in a different clinical study
- Presence of serious or developing pathology
- Severe liver failure (TP under 50% et bilirubinemia over 3 LSN)
- Thrombocytopenia with platelet level under 50 000 cells /ml
- Known severe renal pathology (creatinine clearance under 50 ml/min)
- Clinical or biological problem corresponding to indications of grade over or equal 3 of WHO classification
- Karnofsky under 70 percent
- Opportunistic infections
- Patients taking medications not recommended in the context of the protocol
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00158457
Start Date
June 1 2004
End Date
December 1 2006
Last Update
July 3 2007
Active Locations (2)
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1
Centre de Traitement Ambulatoire, CHU de Fann
Dakar, Senegal
2
Service des Maladies Infectieuses, CHU de Fann
Dakar, Senegal