Simple Once Daily Triple Regimen Including Tenofovir, Emtricitabine and Efavirenz in HIV-1 Infected Patients (ANRS 1207)

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00158457

Enrollment

Registered

2005-09-12

Start date

2004-06-30

Completion date

2006-12-31

Last updated

2007-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

Simplification regimen, HIV infection, Once a day, Naive patients, Sub-saharian Africa, Treatment Naive

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 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.

Interventions

DRUGTenofovir (TDF)

DRUGEmtricitabine (FTC)

DRUGEfavirenz (EFV)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	S48

Secondary

Measure	Time frame
Viral load evolution	S24 and S48
Genotype resistance profile evaluation failing patients	S24, S48, S96
Immune benefits of the combination	—
Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml	S24 and S96
Adverse events clinic and lipids	—
Compliance	S48 and S96
Plasma concentrations of FTC, TDF and EFV	S4

Countries

Senegal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026