Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients

HIV Infections Clinical Trial

Official title:

Phase IV, Open-Label, Randomized, Multicenter Study Evaluating Efficacy and Tolerability of Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir DF Compared to Unmodified HAART in HIV-1 Infected Subjects Who Have Achieved Virological Suppression on Their HAART Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365612
• Other study ID #: AI266073
• Status: Completed
• Phase: Phase 4
• First received: August 16, 2006
• Last updated: April 9, 2008
• Start date: July 2006
• Est. completion date: January 2008

Study information

• Verified date: April 2008
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To compare the effectiveness (efficacy, safety & tolerability) of a Single Tablet Regimen of efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured by the proportion of patients who maintain viral load (HIV-1 RNA) <200 copies/mL at Week 48.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• HIV-1 positive patients who have maintained an HIV-1 viral load <200 copies/mL, for at least 3 months.

• Patients must be on their first HAART or have documented viral suppression on a PI-based regimen at the time of any prior change in therapy.

• HAART must consist of either:

1. A PI (with or without ritonavir) + at least 2 NRTIs or

2. An NNRTI + at least 2 NRTIs.

• Negative serum pregnancy test.

Exclusion Criteria:

• Patients who have taken any NNRTI prior to their current therapy.

• Patients who have taken a NRTI-only therapy for greater than 7 days prior to their current therapy.

• Patients who are currently taking EFV+FTC+TDF.

• Patients who have a creatinine clearance of <60 mL/min by Cockcroft-Gault estimation.

• Patients who have experienced virologic failure with any previous ARV therapy.

• Patients who have documented resistance to any of the study agents at any time in the past.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gilead Sciences	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary: Proportion of patients with HIV-1 RNA levels <200 copies/mL at Week 48
Primary	Safety Outcome Measures: Adverse Events, Laboratory Tests
Primary	Outcomes Research Measures: Quality of life, adherence, preference of medication, perceived ease of regimen, HIV symptoms

External Links

•   ATRIPLA website
•   Bristol-Myers Squibb website
•   Gilead Sciences website