NCT00643968

Brief Summary

Primary objective: Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (\< 50 copies/mL) (c/mL) at 48 weeks (W48) Main Secondary objectives: Comparison of the two arms for genotypic resistance profile in case of virological failure CD4 changes from baseline Evolution of the lipid profile and morphological changes in fat distribution, and safety Efficacy and genotypic profile data, results of lipid markers, morphological changes and main biological parameters

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for phase_4 hiv-infections

Timeline
Completed

Started Mar 2003

Typical duration for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
Last Updated

June 30, 2008

Status Verified

June 1, 2008

Enrollment Period

2.3 years

First QC Date

March 20, 2008

Last Update Submit

June 27, 2008

Conditions

HIV Infections

Keywords

HIV virological controlLipid profile and morphological fat distributionTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48)

    48 wks

Secondary Outcomes (3)

  • Comparison of the two arms for genotypic resistance profile in case of virological failure

    48 wks

  • CD4 changes from baseline

    48 wks

  • Evolution of the lipid profile and morphological changes in fat distribution, and safety

    48 wks

Study Arms (2)

1

ACTIVE COMPARATOR

TDF+EFV

Drug: EFV+TDF

2

EXPERIMENTAL

TDF+3TC+EFV

Drug: EFV+3TC+TDF

Interventions

EFV+TDFDRUG
1
EFV+3TC+TDFDRUG
2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable HAART ≥ 3 months
  • HIV-1 RNA \< 50 c/mL ≥ 6 months
  • No HAART failure history

You may not qualify if:

  • Weight \> 45 kg
  • No CD4+ cell count criteria
  • No significant laboratory or clinical abnormalities
  • Creatinine Clearance \> 60 mL/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

France and French West Indies

Paris, France

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Aldo Trylesinski, MD

    Gilead Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

March 1, 2003

Primary Completion

June 1, 2005

Study Completion

September 1, 2005

Last Updated

June 30, 2008

Record last verified: 2008-06

Locations

FR(1)