Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial (COOL)
This study has been completed.
Sponsor:
Gilead Sciences
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00643968
First received: March 20, 2008
Last updated: June 27, 2008
Last verified: June 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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:
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 ]
Secondary Outcome Measures:
- Comparison of the two arms for genotypic resistance profile in case of virological failure [ Time Frame: 48 wks ]
- CD4 changes from baseline [ Time Frame: 48 wks ]
- Evolution of the lipid profile and morphological changes in fat distribution, and safety [ Time Frame: 48 wks ]
| 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) |
| Sexes Eligible for Study: | All |
| 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
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 |
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 May 22, 2017