NCT00643968

CompletedPhase 4

Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efa...

Gilead Sciences Source

Gilead Sciences

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

GS-FR-104-1016

Study Type

interventional

Actual enrollment (reported)

140

Locations

1 country

Sites

1

Timeline

Study Start

March 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2005

Actual (reported)

Study Completion

September 2005

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 140 participants
Study completion date: September 2005
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2003
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
June 2005
Actual (reported)
Study Completion
September 2005
Actual (reported)
First Submitted
March 20, 2008
Actual (reported)
First Posted
March 26, 2008
Actual (reported)

Last Updated: June 30, 2008
Status Verified: June 2008
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Gilead Sciences
Industrylead

Study Sites (1)

France and French West Indies

Paris, France

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

Enrollment

140 participants (actual enrollment reported by the registry).

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 2003

Date type not reported

This date has not been verified as actual or estimated.

NCT00365612

Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients

Phase 4Completed

NCT00143728

3TC or No 3TC for HIV With 3TC Resistance

Phase 4Suspended

NCT00312754

A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome

Phase 4Terminated

NCT00648817

Metabolic Impact Assessment of Tenofovir Disoproxil Fumarate on Non-HIV-1 Infected Healthy Adult Male Volunteers

Phase 4Completed

NCT00256828

Once a Day (QD) - Twice a Day (BID) Clinical Trial: Didanosine, Lamivudine and Efavirenz Versus Zidovudine, Lamivudine and Efavirenz in the Starting Treatment of HIV

Phase 4Completed

NCT00724711

Safety and Efficacy Study of Switching From Epzicom to Truvada

Phase 4Completed

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.

Primary Completion

June 2005

Actual (reported)

Study Completion

September 2005

Actual (reported)

Last Updated

June 30, 2008

Record last verified: 2008-06

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00643968
Data provider: ClinicalTrials.gov
Source updated: 2008-06-30
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:55 UTC

Locations

FR(1)

Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations