NCT00038506

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2002

Typical duration for phase_4

Geographic Reach
1 country

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2002

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

April 8, 2015

Status Verified

October 1, 2010

Enrollment Period

2.4 years

First QC Date

May 31, 2002

Last Update Submit

April 6, 2015

Conditions

HIV Infection

Keywords

HIV-1 TRIZIVIR Tenofovir

Outcome Measures

Primary Outcomes (1)

  • HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load.

    48 weeks

Secondary Outcomes (1)

  • Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes

    24 weeks

Interventions

abacavir/lamivudine/zidovudineDRUG
tenofovirDRUG
Also known as: abacavir/lamivudine/zidovudine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

GSK Investigational Site

Los Angeles, California, 90027, United States

Location

GSK Investigational Site

San Rafael, California, 94903, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33145, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32206, United States

Location

GSK Investigational Site

Lake Worth, Florida, 33463, United States

Location

GSK Investigational Site

Miami, Florida, 33136, United States

Location

GSK Investigational Site

Miami Beach, Florida, 33139, United States

Location

GSK Investigational Site

North Miami, Florida, 33161, United States

Location

GSK Investigational Site

Orlando, Florida, 32804, United States

Location

GSK Investigational Site

Tallahassee, Florida, 32303, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30309, United States

Location

GSK Investigational Site

Decatur, Georgia, 30033, United States

Location

GSK Investigational Site

Chicago, Illinois, 60657, United States

Location

GSK Investigational Site

Maywood, Illinois, 60153, United States

Location

GSK Investigational Site

Lafayette, Indiana, 47904, United States

Location

GSK Investigational Site

Berkeley, Michigan, 48072, United States

Location

GSK Investigational Site

New York, New York, 10014, United States

Location

GSK Investigational Site

The Bronx, New York, 10461, United States

Location

GSK Investigational Site

Valhalla, New York, 10595, United States

Location

GSK Investigational Site

Tulsa, Oklahoma, 74114, United States

Location

GSK Investigational Site

Arlington, Texas, 76015, United States

Location

GSK Investigational Site

Dallas, Texas, 75208, United States

Location

GSK Investigational Site

Dallas, Texas, 75216, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Houston, Texas, 77004, United States

Location

GSK Investigational Site

Seattle, Washington, 98104, United States

Location

GSK Investigational Site

Green Bay, Wisconsin, 54301, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

abacavir, lamivudine, and zidovudine drug combinationTenofovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 31, 2002

First Posted

June 3, 2002

Study Start

March 1, 2002

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

April 8, 2015

Record last verified: 2010-10

Locations

US(27)