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

May 5, 2006
June 6, 2008
September 2004
October 2006   (final data collection date for primary outcome measure)
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 ]
  • Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week
  • 48
Complete list of historical versions of study NCT00323687 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1 Infection
Drug: Truvada
300mg / 200 mg QD tenofovir DF and Emtricitabine Fixed Dose Combination (FDC) Tablet (oral)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2007
October 2006   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00323687
GS-DE-164-0106
No
Thomas Mertenskoetter, Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Thomas Mertenskoetter Gilead Sciences
Gilead Sciences
June 2008

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