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

Purpose

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

Condition	Intervention	Phase
HIV Infections	Drug: EFV+TDF Drug: EFV+3TC+TDF	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Randomized Multicenter Open-Label, Pilot Trial to Evaluate the Efficacy and Safety of Switching HIV-1 Stable Infected Patients Under HAART to a New Once Daily Triple Therapy Combination Including EFV+3TC+TDF Versus a Dual QD Therapy Containing EFV+TDF

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lamivudine

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

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) [ Time Frame: 48 wks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of the two arms for genotypic resistance profile in case of virological failure [ Time Frame: 48 wks ] [ Designated as safety issue: No ]
CD4 changes from baseline [ Time Frame: 48 wks ] [ Designated as safety issue: No ]
Evolution of the lipid profile and morphological changes in fat distribution, and safety [ Time Frame: 48 wks ] [ Designated as safety issue: Yes ]


Enrollment:	140
Study Start Date:	March 2003
Study Completion Date:	September 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 TDF+EFV	Drug: EFV+TDF
Experimental: 2 TDF+3TC+EFV	Drug: EFV+3TC+TDF

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643968

Locations


France
France and French West Indies
Paris, France

Sponsors and Collaborators

Gilead Sciences

Investigators


Principal Investigator:	Aldo Trylesinski, MD	Gilead Sciences

More Information


Responsible Party:	Dr Aldo Trylesinski- Gilead Sciences, Gilead Sciences, Inc.
ClinicalTrials.gov Identifier:	NCT00643968 History of Changes
Other Study ID Numbers:	GS-FR-104-1016
Study First Received:	March 20, 2008
Last Updated:	June 27, 2008
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Gilead Sciences:


HIV virological control Lipid profile and morphological fat distribution Treatment Experienced

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2016

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