NCT00158457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 3, 2007

Status Verified

July 1, 2007

First QC Date

September 8, 2005

Last Update Submit

July 2, 2007

Conditions

HIV Infection

Keywords

Simplification regimenHIV infectionOnce a dayNaive patientsSub-saharian AfricaTreatment Naive

Outcome Measures

Primary Outcomes (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

    S48

Secondary Outcomes (7)

  • Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml

    S24 and S96

  • Viral load evolution

    S24 and S48

  • Genotype resistance profile evaluation failing patients

    S24, S48, S96

  • Immune benefits of the combination

  • Plasma concentrations of FTC, TDF and EFV

    S4

  • +2 more secondary outcomes

Interventions

Tenofovir (TDF)DRUG
Emtricitabine (FTC)DRUG
Efavirenz (EFV)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre de Traitement Ambulatoire, CHU de Fann

Dakar, Senegal

Location

Service des Maladies Infectieuses, CHU de Fann

Dakar, Senegal

Location

MeSH Terms

Conditions

HIV Infections

Interventions

TenofovirEmtricitabineRacivirefavirenz

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Roland Landman

    IMEA- Hôpital Bichat Claude Bernard, France

    STUDY CHAIR

  • Papa Salif Sow

    CHU de Fann, Dakar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

June 1, 2004

Study Completion

December 1, 2006

Last Updated

July 3, 2007

Record last verified: 2007-07

Locations

SE(2)