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

NCT ID: NCT00323687

Last Updated: 2008-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-01-31

Brief Summary

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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

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Conditions

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HIV-1 Infection

Keywords

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HIV-1 Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Truvada

300mg / 200 mg QD tenofovir DF and Emtricitabine Fixed Dose Combination (FDC) Tablet (oral)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Gilead Sciences

Principal Investigators

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Thomas Mertenskoetter

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Gilead Sciences GmbH

Martinsried, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.gileadclinicaltrials.com/pdf/GS-DE-164-0106_synopsis.pdf

Study Results

Other Identifiers

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GS-DE-164-0106

Identifier Type: -

Identifier Source: org_study_id