NCT Number: NCT00158457
Simple Once Daily Triple Regimen Including Tenofovir, Emtricitabine and Efavirenz in HIV-1 Infected Patients (ANRS 1207)
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 one intake of 3 pills per day. This combination has already been studied in the North countries.
Here in Senegal, the efficacy and the compliance to treatment will be evaluated after 24, 48 and 96 weeks of treatment.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Centre de Traitement Ambulatoire, CHU de Fann, Dakar, Senegal
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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
Treatment and study plan
Emtricitabine (FTC)
DrugEfavirenz (EFV)
DrugPrimary outcomes
-
Evaluation of the antiretroviral efficacy as first line treatment assessed as percentage of patients with viral load below 400 copies/ml at week 48 in the intention to treat (ITT) population
Time frame: S48
Secondary outcomes
-
Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml
Time frame: S24 and S96
-
Viral load evolution
Time frame: S24 and S48
-
Genotype resistance profile evaluation failing patients
Time frame: S24, S48, S96
-
Immune benefits of the combination
-
Plasma concentrations of FTC, TDF and EFV
Time frame: S4
-
Adverse events clinic and lipids
-
Compliance
Time frame: S48 and S96
Sponsors and collaborators
Lead sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Other Gov
Collaborators
- Gilead Sciences
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Registry information
Official study title
Pilot Trial to Evaluate the Efficacy and Tolerance of a Simple Once Daily Combined Regimen Including Tenofovir (TDF), Emtricitabine (FTC) and Efavirenz (EFV) in HIV-1 Infected Patients Naive to Prior Antiretroviral Treatment in Senegal
Important dates
- Study start
- 2004
- Study completion
- 2006
- First posted
- Sep 12, 2005
- Registry last updated
- Jul 3, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
MAPS PrEP Van Study
NCT06908252
Blood-Borne Infections, Communicable Diseases
Durham, North Carolina, United States
View Trial DetailsAntiretroviral Adherence Evaluation in HIV Pregnant and Postpartum Women
NCT01621347
Behavior, Blood-Borne Infections
Lausanne, Canton of Vaud, Switzerland
View Trial DetailsTenofovir, Emtricitabine and Efavirenz Late Switch to a Single Pill: Patients' Opinion Survey
NCT01322932
Behavior, Blood-Borne Infections
Lausanne, Canton of Vaud, Switzerland
View Trial DetailsHIV Disclosure and Medication Adherence, a Pilot Study
NCT01621412
Behavior, Blood-Borne Infections
Lausanne, Canton of Vaud, Switzerland
View Trial Details