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NCT00038506 Clinical Trial

Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure

HIV Infection Clinical Trial

Official title:
A Phase IV, Open-label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-daily for 48 Weeks in HIV-infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensification Protocol)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00038506
Other study ID # ESS 30005
Secondary ID
Status Completed
Phase Phase 4
First received May 31, 2002
Last updated April 6, 2015
Start date March 2002
Est. completion date August 2004

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

Clinical Trial Summary

This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date August 2004
Est. primary completion date August 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor).

- Plasma HIV - 1 RNA was <400 copies/ml on at least 2 documented occasions prior to viral rebound.

- Have a plasma HIV - 1 RNA value >400 copies/ml and <10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks.

- A CD4+ lymphocyte count less than or equal to 100.

Exclusion Criteria:

- Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously.

- Have not had an AIDS defining illness within 30 days of screen.

- Pregnant or breast-feeding.

- Specified viral genotypes upon screening.

- And other inclusion or exclusion criteria to be evaluated by the physician.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• abacavir/lamivudine/zidovudine

• tenofovir

Locations
Country Name City State
United States GSK Investigational Site Arlington Texas
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Berkeley Michigan
United States GSK Investigational Site Bronx New York
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Dallas Texas
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 Fort Lauderdale Florida
United States GSK Investigational Site Green Bay Wisconsin
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Jacksonville Florida
United States GSK Investigational Site Lafayette Indiana
United States GSK Investigational Site Lake Worth Florida
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Maywood Illinois
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Beach Florida
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 San Rafael California
United States GSK Investigational Site Seattle Washington
United States GSK Investigational Site Tallahassee Florida
United States GSK Investigational Site Tulsa Oklahoma
United States GSK Investigational Site Valhalla New York

Sponsors (1)
Lead Sponsor Collaborator
ViiV Healthcare

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load. 48 weeks
Secondary Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes 24 weeks
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