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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00158457
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 3, 2007
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

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.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: Tenofovir (TDF) Drug: Emtricitabine (FTC) Drug: Efavirenz (EFV) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2004
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. 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 :
  1. Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml [ Time Frame: S24 and S96 ]
  2. Viral load evolution [ Time Frame: S24 and S48 ]
  3. Genotype resistance profile evaluation failing patients [ Time Frame: S24, S48, S96 ]
  4. Immune benefits of the combination
  5. Plasma concentrations of FTC, TDF and EFV [ Time Frame: S4 ]
  6. Adverse events clinic and lipids
  7. Compliance [ Time Frame: S48 and S96 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00158457

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Centre de Traitement Ambulatoire, CHU de Fann
Dakar, Senegal
Service des Maladies Infectieuses, 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
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Study Chair: Roland Landman IMEA- Hôpital Bichat Claude Bernard, France
Principal Investigator: Papa Salif Sow CHU de Fann, Dakar
Layout table for additonal information Identifier: NCT00158457    
Other Study ID Numbers: ANRS 1207
IMEA 025
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 3, 2007
Last Verified: July 2007
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:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers