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

This study has been completed.

First Received on September 8, 2005. Last Updated on July 2, 2007 History of Changes

Sponsor:	French National Agency for Research on AIDS and Viral Hepatitis
Collaborators:	Gilead Sciences Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00158457

Purpose

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.

Condition	Intervention	Phase
HIV Infection	Drug: Tenofovir (TDF) Drug: Emtricitabine (FTC) Drug: Efavirenz (EFV)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Tenofovir Efavirenz Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:

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 Outcome Measures:

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 ]

Enrollment:	40
Study Start Date:	June 2004
Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158457

Locations

Senegal
Service des Maladies Infectieuses, CHU de Fann
Dakar, Senegal
Centre de Traitement Ambulatoire, CHU de Fann
Dakar, Senegal

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Gilead Sciences

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Investigators

Study Chair:	Roland Landman	IMEA- Hôpital Bichat Claude Bernard, France
Principal Investigator:	Papa Salif Sow	CHU de Fann, Dakar

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00158457 History of Changes
Other Study ID Numbers:	ANRS 1207, IMEA 025
Study First Received:	September 8, 2005
Last Updated:	July 2, 2007
Health Authority:	Senegal: Ministere de la sante

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

Simplification regimen
HIV infection
Once a day

Naive patients
Sub-saharian Africa
Treatment Naive

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir
Tenofovir disoproxil

Efavirenz
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 09, 2012