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

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ClinicalTrials.gov Identifier: NCT00323687
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : June 9, 2008
Sponsor:
Information provided by:
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE May 5, 2006
First Posted Date  ICMJE May 9, 2006
Last Update Posted Date June 9, 2008
Study Start Date  ICMJE September 2004
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2008)
Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 48 [ Time Frame: Week 48 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2006)
  • Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week
  • 48
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2008)
  • Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 24 [ Time Frame: 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 [ Time Frame: Up to 48 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2006)
  • Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week
  • 24
  • 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
  • Adherence to HIV treatments
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SONETT: Switch Study to Once Daily HIV Treatment Regimen With Truvada
Official Title  ICMJE Switch to a Completely ONce Daily Regimen Containing Emtricitabine/Tenofovir - Fixed Dose Combination Plus Third QD Partner: "SONETT"
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infection
Intervention  ICMJE Drug: Truvada
300mg / 200 mg QD tenofovir DF and Emtricitabine Fixed Dose Combination (FDC) Tablet (oral)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 5, 2006)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00323687
Other Study ID Numbers  ICMJE GS-DE-164-0106
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Mertenskoetter, Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Thomas Mertenskoetter Gilead Sciences
PRS Account Gilead Sciences
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP