HIV InfectionsPhase 4TOTEMNCT00323492

TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada

A Phase 4 study testing Truvada and Current HAART regimen in people with HIV Infections, run by Gilead Sciences at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study looked at lipid changes in human immunodeficiency virus type 1 (HIV-1) infected patients when the nucleoside reverse transcriptase inhibitors (NRTIs) in their existing highly active antiretroviral therapy (HAART) regimen were switched to Truvada® (a fixed dose combination tablet of emtricitabine/tenofovir… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: Truvada and Current HAART regimen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 1 siteFrance
Study dates: Sep 2005to Mar 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients displaying abnormal fasted triglycerides (> 2 g/L [2.26 mmol/L] and less than or equal to 10 g/L [11.29 mmol/L]) and/or fasted low density lipoprotein cholesterol (LDL-CHO; > 1.6 g/L [4.15 mmol/L])
Patients on stable HAART with 2 NRTIs + 1 NNRTI or 1 PI for at least 3 months prior to screening, and with plasma viral load < 400 copies/mL for at least 6 months prior to screening

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

France1 site

Gilead Sciences
Paris, 75015

Other trials in France

About this study

Official title: Open-label Randomized Multicenter Trial to Evaluate the Impact on the Lipid Profile of the Substitution of the NRTIs of a HAART Regimen by a Once Daily Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus Maintained Treatment in HIV Infected Controlled Patients.

Read the detailed description

This was a Phase IV, multicenter (in France), open label study. The study was conducted in two phases: a comparative randomized phase, which served the primary objective of the study, and a follow-up phase.

Study Phase 1, Day -14 to Week 12: patients were randomized on a 1:1 basis to one of two groups:

A. Truvada (substitution of their current NRTIs by Truvada [FTC/TDF] with continuation of their current NNRTI or PI at the same dose)
B. Maintain Baseline Regimen (continuation of previous HAART regimen, i.e., maintained baseline regimen).

This phase of the study served the primary objective of the study.

Study Phase 2, roll-over follow-up, Week 12 to Week 48: Patients in the Truvada group continued with Truvada + an NNRTI or PI. Patients in the control group could switch their NRTIs to Truvada in this phase of the study (Delayed Truvada group).

Patients were assessed for efficacy and safety during both phases of the study.

Conditions: HIV Infections
Being tested: Truvada, Current HAART regimen
Keywords: HIV 1 Infection
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TruvadaDrug
Truvada + NNRTI or PI.
Current HAART regimenDrug
Maintain baseline regimen

Study groups in NCT00323492
Study group	Role	What they receive
Truvada	Experimental	Truvada once daily with continuation of the current NNRTI or PI at randomization Receives: Drug: Truvada
Maintain Baseline Regimen	Active comparator	Maintain baseline regimen Receives: Drug: Current HAART regimen
Delayed Truvada	Experimental	Truvada once daily with NNRTI or PI (participants from the comparator group who switched to Truvada during Study Phase 2) Receives: Drug: Truvada
All Truvada	Experimental	Truvada once daily with NNRTI or PI (all participants who received Truvada during the study, i.e., participants in the Truvada and Delayed Truvada groups) Receives: Drug: Truvada

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Week 12 in Fasting Triglycerides
Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Measured: Baseline to Week 12
Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO)
Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Measured: Baseline to Week 12

Secondary outcomes (11)

Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO)
Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Measured: Baseline to Week 12
Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO)
Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Measured: Baseline to Week 12
Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO
Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Measured: Baseline to Week 12
Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO
Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Measured: Baseline to Week 12
Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP)
Local laboratory assessment. Change = Week 12 value minus baseline value.
Measured: Baseline to Week 12
Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12
Centralized laboratory assessment
Measured: 12 weeks
Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count
Change = Week 12 value minus baseline value.
Measured: Baseline to Week 12
Change From Baseline to Week 48 in CD4 Cell Count
Change = Week 48 value minus baseline value.
Measured: Baseline to Week 48
Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12
Measured: 12 weeks
Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12
Measured: 12 weeks
Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005Mar 2008

First posted9 May 2006 (estimated)
Study startSep 2005
Primary completionJul 2007
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00323492
Sponsor's protocol ID: GS-FR-164-0109
Acronym: TOTEM
Status last verified: Jan 2010
First submitted: 5 May 2006
Last updated: 20 Jan 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Valantin MA, Bittar R, de Truchis P, Bollens D, Slama L, Giral P, Bonnefont-Rousselot D, Petour P, Aubron-Olivier C, Costagliola D, Katlama C; TOTEM trial group. Switching the nucleoside reverse transcriptase inhibitor backbone to tenofovir disoproxil fumarate + emtricitabine promptly improves triglycerides and low-density lipoprotein cholesterol in dyslipidaemic patients. J Antimicrob Chemother. 2010 Mar;65(3):556-61. doi: 10.1093/jac/dkp462. Epub 2010 Jan 6.
PubMed 20053692

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label Randomized Multicenter Trial to Evaluate the Impact on the Lipid Profile of the Substitution of the NRTIs of a HAART Regimen by a Once Daily Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus Maintained Treatment in HIV Infected Controlled Patients.
ClinicalTrials.gov ID: NCT00323492
Acronym / sponsor ID: TOTEM / GS-FR-164-0109
Conditions: HIV Infections
Keywords: HIV 1 Infection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Jul 2007 (actual)
Study completion: Mar 2008 (actual)
First posted: 9 May 2006 (estimated)
Results: Posted 23 Dec 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Phase 1, Day -14 to Week 12: patients were randomized on a 1:1 basis to one of two groups:

A. Truvada (substitution of their current NRTIs by Truvada [FTC/TDF] with continuation of their current NNRTI or PI at the same dose)
B. Maintain Baseline Regimen (continuation of previous HAART regimen, i.e., maintained baseline regimen).

This phase of the study served the primary objective of the study.

Patients were assessed for efficacy and safety during both phases of the study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Truvada	Experimental	Drug: TruvadaTruvada once daily with continuation of the current NNRTI or PI at randomization
Maintain Baseline Regimen	Active comparator	Drug: Current HAART regimenMaintain baseline regimen
Delayed Truvada	Experimental	Drug: TruvadaTruvada once daily with NNRTI or PI (participants from the comparator group who switched to Truvada during Study Phase 2)
All Truvada	Experimental	Drug: TruvadaTruvada once daily with NNRTI or PI (all participants who received Truvada during the study, i.e., participants in the Truvada and Delayed Truvada groups)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients displaying abnormal fasted triglycerides (> 2 g/L [2.26 mmol/L] and less than or equal to 10 g/L [11.29 mmol/L]) and/or fasted low density lipoprotein cholesterol (LDL-CHO; > 1.6 g/L [4.15 mmol/L])
Patients on stable HAART with 2 NRTIs + 1 NNRTI or 1 PI for at least 3 months prior to screening, and with plasma viral load < 400 copies/mL for at least 6 months prior to screening

Key exclusion criteria (0 listed)

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
TruvadaTruvada + NNRTI or PI.	Drug	All Truvada, Delayed Truvada, Truvada
Current HAART regimenMaintain baseline regimen	Drug	Maintain Baseline Regimen

Primary outcome

Change From Baseline to Week 12 in Fasting Triglycerides
Time frame: Baseline to Week 12
Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO)
Time frame: Baseline to Week 12
Centralized laboratory assessment. Change = Week 12 value minus baseline value.

11 secondary outcomes

Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO)
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO)
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP)
Time frame: Baseline to Week 12
Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12
Time frame: 12 weeks
Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count
Time frame: Baseline to Week 12
Change From Baseline to Week 48 in CD4 Cell Count
Time frame: Baseline to Week 48
Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12
Time frame: 12 weeks
Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12
Time frame: 12 weeks
Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48
Time frame: 48 weeks

Results and safety

Results posted to the registry on 23 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Truvada	47	45
Maintain Baseline Regimen	45	45
Delayed Truvada	0	0

Primary outcome: Change From Baseline to Week 12 in Fasting Triglycerides

Time frame: Baseline to Week 12. Median (Inter-Quartile Range). Unit: mmol/L

Measure	Truvada n = 44	Maintain Baseline Regimen n = 45
Value	-0.5 (-1.2 to 0.0)	-0.1 (-0.8 to 0.3)

Truvada vs Maintain Baseline Regimen: Median Difference (Net): -0.42 (95% CI -0.86 to -0.03), p = 0.034, Wilcoxon Rank Sum test

Population analysed: ITT. Last post-baseline observation carried forward (LOCF) method was used for the analysis if the Week 12 value was missing. A missing datum were replaced by the last post-baseline value.

Primary outcome: Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO)

Time frame: Baseline to Week 12. Median (Inter-Quartile Range). Unit: mmol/L

Measure	Truvada n = 44	Maintain Baseline Regimen n = 45
Value	-0.4 (-1.0 to 0.1)	-0.1 (-0.5 to 0.4)

Truvada vs Maintain Baseline Regimen: Median Difference (Net): -0.36 (95% CI -0.67 to -0.03), p = 0.031, Wilcoxon Rank Sum text

Population analysed: ITT. LOCF method was used for the analysis if the Week 12 value was missing. A missing datum were replaced by the last post-baseline value.

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Truvada	7 of 47 (14.9%)	15 of 47 (31.9%)	Not reported
Maintain Baseline Regimen	3 of 45 (6.7%)	6 of 45 (13.3%)	Not reported
All Truvada	7 of 72 (9.7%)	16 of 72 (22.2%)	Not reported

Limitations and caveats (from the sponsor): Comparison of adverse events between Truvada and maintain baseline regimen groups is inappropriate since numbers at risk (and exposure to study drug) are not balanced, as described in the adverse event treatment group descriptions.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20053692Valantin MA, Bittar R, de Truchis P, Bollens D, Slama L, Giral P, Bonnefont-Rousselot D, Petour P, Aubron-Olivier C, Costagliola D, Katlama C; TOTEM trial group. Switching the nucleoside reverse transcriptase inhibitor backbone to tenofovir disoproxil fumarate + emtricitabine promptly improves triglycerides and low-density lipoprotein cholesterol in dyslipidaemic patients. J Antimicrob Chemother. 2010 Mar;65(3):556-61. doi: 10.1093/jac/dkp462. Epub 2010 Jan 6.

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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.

Camille Aubron-Olivier study director

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 Truvada and Current HAART regimen 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 2 inclusion and 0 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 20 Jan 2010. 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?

Yes. Results are posted in the registry (first posted 23 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline to Week 12 in Fasting Triglycerides (time frame: Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00323492, which also lists 1 linked publication.

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 20 Jan 2010.