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NCT00053638 Clinical Trial

A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

HIV Infection Clinical Trial

Official title:
A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV-1 Infected Subjects.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00053638
Other study ID # ESS30009
Secondary ID
Status Completed
Phase Phase 3
First received February 4, 2003
Last updated October 1, 2010
Start date February 2003
Est. completion date October 2004

Study information
Verified date October 2010
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.

Recruitment information / eligibility
Status Completed
Enrollment 345
Est. completion date October 2004
Est. primary completion date October 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- Participants must be able to provide informed consent.

- Have documented HIV-1 infection.

- Have not received more than 14 days of prior treatment with antiretroviral drugs.

- Meet laboratory test criteria.

- Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception.

- Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study.

Exclusion criteria:

- Enrolled in other HIV treatment studies.

- Pregnant or breastfeeding.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• efavirenz

• tenofovir

• abacavir/lamivudine

Locations
Country Name City State
United States GSK Investigational Site Albany New York
United States GSK Investigational Site Albuquerque New Mexico
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Buffalo New York
United States GSK Investigational Site Charlotte North Carolina
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Cincinnati Ohio
United States GSK Investigational Site Columbia South Carolina
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Decatur Georgia
United States GSK Investigational Site Denver Colorado
United States GSK Investigational Site Denver Colorado
United States GSK Investigational Site Fort Collins Colorado
United States GSK Investigational Site Fort Lauderdale Florida
United States GSK Investigational Site Fort Lauderdale Florida
United States GSK Investigational Site Fort Lauderdale Florida
United States GSK Investigational Site Fort Myers Florida
United States GSK Investigational Site Fort Worth Texas
United States GSK Investigational Site Fountain Valley California
United States GSK Investigational Site Green Bay Wisconsin
United States GSK Investigational Site Hampton Virginia
United States GSK Investigational Site Hershey Pennsylvania
United States GSK Investigational Site Hillsborough New Jersey
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Indianapolis Indiana
United States GSK Investigational Site Jacksonville Florida
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Lynchburg Virginia
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Minneapolis Minnesota
United States GSK Investigational Site New Orleans Louisiana
United States GSK Investigational Site New Orleans Louisiana
United States GSK Investigational Site New York New York
United States GSK Investigational Site New York New York
United States GSK Investigational Site North Miami Florida
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Phoenix Arizona
United States GSK Investigational Site Portland Oregon
United States GSK Investigational Site Portland Oregon
United States GSK Investigational Site Providence Rhode Island
United States GSK Investigational Site Reading Pennsylvania
United States GSK Investigational Site San Francisco California
United States GSK Investigational Site Seattle Washington
United States GSK Investigational Site Stony Brook New York
United States GSK Investigational Site Tacoma Washington
United States GSK Investigational Site Tampa Florida
United States GSK Investigational Site Tyler Texas
United States GSK Investigational Site Vero Beach Florida
United States GSK Investigational Site Washington District of Columbia
United States GSK Investigational Site Washington District of Columbia
United States GSK Investigational Site Washington District of Columbia
United States GSK Investigational Site Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Viral load response at 48 weeks 48 weeks
Secondary Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics 48 weeks
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