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

This study has been completed.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00323687
First received: May 5, 2006
Last updated: June 6, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection
Drug: Truvada
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Switch to a Completely ONce Daily Regimen Containing Emtricitabine/Tenofovir - Fixed Dose Combination Plus Third QD Partner: "SONETT"

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2004
Study Completion Date: January 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Truvada
    300mg / 200 mg QD tenofovir DF and Emtricitabine Fixed Dose Combination (FDC) Tablet (oral)
  Eligibility

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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323687

Locations
Germany
Gilead Sciences GmbH
Martinsried, Germany, 82152
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Thomas Mertenskoetter Gilead Sciences
  More Information

No publications provided

Responsible Party: Thomas Mertenskoetter, Gilead Sciences
ClinicalTrials.gov Identifier: NCT00323687     History of Changes
Other Study ID Numbers: GS-DE-164-0106
Study First Received: May 5, 2006
Last Updated: June 6, 2008
Health Authority: Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM)

Keywords provided by Gilead Sciences:
HIV-1 Infection

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on October 22, 2014