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

HIV Infections Clinical Trial

— TOTEM  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323492
• Other study ID #: GS-FR-164-0109
• Status: Completed
• Phase: Phase 4
• First received: May 5, 2006
• Last updated: January 13, 2010
• Start date: September 2005
• Est. completion date: March 2008

Study information

• Verified date: January 2010
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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 disoproxil fumarate 200 mg/300 mg [FTC/TDF]). Subjects continued their nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) at the same dose.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Truvada
Truvada + NNRTI or PI.
• Current HAART regimen
Maintain baseline regimen

Locations

Country	Name	City	State
France	Gilead Sciences	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 12 in Fasting Triglycerides		Baseline to Week 12	Yes
Primary	Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO)		Baseline to Week 12	Yes
Secondary	Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO)		Baseline to Week 12	Yes
Secondary	Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO)		Baseline to Week 12	Yes
Secondary	Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO		Baseline to Week 12	Yes
Secondary	Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO		Baseline to Week 12	Yes
Secondary	Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP)		Baseline to Week 12	Yes
Secondary	Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12		12 weeks	Yes
Secondary	Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count		Baseline to Week 12	No
Secondary	Change From Baseline to Week 48 in CD4 Cell Count		Baseline to Week 48	No
Secondary	Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12		12 weeks	No
Secondary	Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12		12 weeks	No
Secondary	Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48		48 weeks	No