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Completed

NCT Number: NCT00643968

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

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

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

France and French West Indies

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EFV+TDF

Drug

EFV+3TC+TDF

Drug

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)

    Time frame: 48 wks

Secondary outcomes

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

    Time frame: 48 wks

  2. CD4 changes from baseline

    Time frame: 48 wks

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

    Time frame: 48 wks

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Acronym: COOL

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Mar 26, 2008
Registry last updated
Jun 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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