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

Sponsor:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00323492

Purpose

This study looks at lipid changes in HIV infected patients when they are switched from existing HIV treatment to a treatment containing Truvada.

Condition	Intervention	Phase
HIV Infections	Drug: Truvada Drug: Current HAART regimen	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Pilot Open-Label Randomized Multicentre Trial to Evaluate the Impact of the Substitution of the NRTIs With TRUVADA in a HAART Combination Over the Lipids Profile in HIV+ Infected Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS Cholesterol

Drug Information available for: Truvada

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

Comparison of the evolution of the lipid profile between the two treatment groups, from baseline to Week 12, evaluated on: Plasma triglyceride level changes [ Time Frame: Through 12 weeks ] [ Designated as safety issue: No ]
Plasma direct measured low-density lipoprotein cholesterol (LDL-CHO) [ Time Frame: Through 12 weeks ] [ Designated as safety issue: No ]
The changes in high-density lipoprotein cholesterol (HDL-CHO), and total cholesterol (T-CHO) levels [ Time Frame: Through 12 weeks ] [ Designated as safety issue: No ]
The changes in T-CHO/ HDL-CHO and HDL-CHO/LDL-CHO ratios [ Time Frame: Through 12 weeks ] [ Designated as safety issue: No ]
The percentage of patients with plasma triglycerides greater than 10 g/L at Week 12 [ Time Frame: Through 12 weeks ] [ Designated as safety issue: No ]
The percentage of patients with plasma HIV-1 viral load less than 400 copies/mL at Week 12 (virological control) [ Time Frame: Through 12 weeks ] [ Designated as safety issue: No ]
The percentage of patients with a plasma HIV-1 viral load greater than 400 copies/mL at Week 12 (virological therapy failure). The genotype of HIV-1 will be analyzed in case of failure [ Time Frame: Through 12 weeks ] [ Designated as safety issue: No ]
The changes of cluster determinant 4 (CD4) cell counts from baseline [ Time Frame: Through 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	April 2005
Study Completion Date:	August 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1A: Experimental Phase 1, Day-14 to Week12:the TVD group (substitution of their current NRTIs by TVD [TDF+FTC] with continuation of their current NNRTI or PI at the same dose)	Drug: Truvada TVD [TDF+FTC] with continuation of their current NNRTI or PI at the same dose
1B: Active Comparator Phase 1, Day-14 to Week12: a control group (continuation of previous HAART regimen)	Drug: Current HAART regimen
2: Experimental Phase 2, roll-over follow-up, Week 12 to Week 48: Patients in the TVD group (Arm A) continue with TVD + an NNRTI or PI. Patients who did not switch in Phase 1 to TVD (Arm B) will be proposed to switch in this phase of the study.	Drug: Truvada TVD [TDF+FTC] with continuation of their current NNRTI or PI at the same dose

Detailed Description:

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

Phase 1, Day-14 to Week12: patients will be, on a 1:1 basis, randomized to two arms: A. the TVD group (substitution of their current NRTIs by TVD [TDF+FTC] with continuation of their current NNRTI or PI at the same dose) or B. a control group (continuation of previous HAART regimen). This phase of the study serves the Primary objective of the study.

Phase 2, roll-over follow-up, Week 12 to Week 48: Patients in the TVD group (Arm A) continue with TVD + an NNRTI or PI. Patients who did not switch in Phase 1 to TVD (Arm B) will be proposed to switch in this phase of the study.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients displaying abnormal plasma lipid levels
Patients with stable highly active antiretroviral therapy (HAART)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323492

Locations

France
Gilead Sciences
Paris, France, 75015

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director:

Camille Aubron-Olivier

Gilead Sciences

More Information

No publications provided

Responsible Party:	Gilead Sciences ( Camille Aubron-Olivier )
Study ID Numbers:	GS-FR-164-0109
Study First Received:	May 5, 2006
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00323492 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Gilead Sciences:

HIV 1 Infection

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 09, 2009