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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00038506
First received: May 31, 2002
Last updated: October 1, 2010
Last verified: October 2010
History of Changes

May 31, 2002
October 1, 2010
March 2002
August 2004   (final data collection date for primary outcome measure)
HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load. [ Time Frame: 48 weeks ]
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Complete list of historical versions of study NCT00038506 on ClinicalTrials.gov Archive Site
Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes [ Time Frame: 24 weeks ]
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Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure
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)

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Drug: abacavir/lamivudine/zidovudine
  • Drug: tenofovir
    Other Names:
    • abacavir/lamivudine/zidovudine
    • tenofovir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2004
August 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00038506
ESS 30005
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP