HIV InfectionsPhase 4COOLNCT00643968
Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial
A Phase 4 study testing EFV+TDF and EFV+3TC+TDF in people with HIV Infections, run by Gilead Sciences at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- EFV+TDF and EFV+3TC+TDF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2003to Sep 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable HAART ≥ 3 months
- HIV-1 RNA < 50 c/mL ≥ 6 months
- No HAART failure history
Who cannot join
- Weight > 45 kg
- No CD4+ cell count criteria
- No significant laboratory or clinical abnormalities
- Creatinine Clearance > 60 mL/min
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- HIV Infections
- Being tested
- EFV+TDF, EFV+3TC+TDF
- Keywords
- HIV virological control, Lipid profile and morphological fat distribution, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFV+TDFDrug
EFV+3TC+TDFDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | TDF+EFV Receives: Drug: EFV+TDF |
| 2 | Experimental | TDF+3TC+EFV Receives: Drug: EFV+3TC+TDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 48 wks
Secondary outcomes (3)
Comparison of the two arms for genotypic resistance profile in case of virological failure
Measured: 48 wks
CD4 changes from baseline
Measured: 48 wks
Evolution of the lipid profile and morphological changes in fat distribution, and safety
Measured: 48 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startMar 2003
- Primary completionJun 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Aldo Trylesinski, MD, Principal investigator, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643968
- Sponsor's protocol ID
- GS-FR-104-1016
- Acronym
- COOL
- Status last verified
- Jun 2008
- First submitted
- 20 Mar 2008
- Last updated
- 30 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00643968
- Acronym / sponsor ID
- COOL / GS-FR-104-1016
- Conditions
- HIV Infections
- Keywords
- HIV virological control, Lipid profile and morphological fat distribution, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: EFV+TDFTDF+EFV |
| 2 | Experimental | Drug: EFV+3TC+TDFTDF+3TC+EFV |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable HAART ≥ 3 months
- HIV-1 RNA < 50 c/mL ≥ 6 months
- No HAART failure history
Key exclusion criteria (4 listed)
- Weight > 45 kg
- No CD4+ cell count criteria
- No significant laboratory or clinical abnormalities
- Creatinine Clearance > 60 mL/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EFV+TDF | Drug | 1 |
| EFV+3TC+TDF | Drug | 2 |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2008.
- Study ResultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aldo Trylesinski, MD principal investigator
Gilead Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EFV+TDF and EFV+3TC+TDF in people with HIV Infections, run by Gilead Sciences at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2008.