SONETT: Switch Study to Once Daily HIV Treatment Regimen With Truvada

Switch to a Completely ONce Daily Regimen Containing Emtricitabine/Tenofovir - Fixed Dose Combination Plus Third QD Partner: "SONETT"

There is an unmet medical need for potent ART regimens that make adherence to treatment even easier due to QD dosing, offer a good tolerability profile and fit into the daily life of patients.

Study Overview

• Status: Completed
• Conditions: HIV-1 Infection
• Intervention / Treatment: Drug: Truvada

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Martinsried, Germany, 82152
    • Gilead Sciences GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Adult patients (over 18 years of age) of any ethnic group without restricted legal competence and who are capable of following the study instructions HIV-1 infection documented by confirmed positive HIV-1 antibody test and/or positive PCR for HIV-1 RNA Stable (no interruption or change of regimen in last 3 months) AZT-and 3TC-containing regimen > 3 months No documented prior virologic failure (virological failure defined as 2 consecutive measurements 4 weeks apart with viral load of HIV-RNA > 400 copies/mL while on ART) CD4+ counts > 50 cells/µL Viral load < 50 copies/mL Karnofsky performance status ≥ 80% For women with childbearing potential, negative urine pregnancy test at Screening visit

Exclusion Criteria:

Serum phosphate level < 0.65 mmol/L Documented active opportunistic infections Subjects with previously documented K65R, 69S mutations or 3 or more thymidine analogue mutations Documented active malignant disease (excluding Kaposi sarcoma limited to the skin) Female of childbearing potential not willing to use a barrier method of contraception during heterosexual intercourse during the duration of study Women who are pregnant or breast feeding Known history of drug, medication or alcohol abuse within the last 12 months preceding the study Simultaneous participation in another study with an investigational drug or within less than one month prior to this study Inability or not willing to meet the requirements of the protocol History of seizures, central nervous system disorders or psychiatric disability thought to be clinically significant in the opinion of the investigator Limited mental capacity to the extent that he/she cannot provide informed consent or information regarding adverse events of the study medication Renal disease (creatinine clearance < 50 ml/min according to Cockroft_Gault formula) or severe hepatic, respiratory or cardiovascular disease Patients who have previously been enrolled into this study Contraindication for one of the study substances.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 48	Week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 24	24 weeks
Time to failure or ART discontinuation. Virological failure is defined as 2 consecutive measurements 4 weeks apart with viral load of HIV-RNA > 400 copies/mL	Up to 48 weeks

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Thomas Mertenskoetter, Gilead Sciences

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: May 5, 2006
• First Submitted That Met QC Criteria: May 5, 2006
• First Posted (Estimate): May 9, 2006

Study Record Updates

• Last Update Posted (Estimate): June 9, 2008
• Last Update Submitted That Met QC Criteria: June 6, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: HIV-1 Infection
• Additional Relevant MeSH Terms: Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
• Other Study ID Numbers: GS-DE-164-0106