ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure

This study has been completed.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00038506
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: abacavir/lamivudine/zidovudine
Drug: tenofovir
Phase IV

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Zidovudine    Lamivudine    Abacavir    Abacavir sulfate    Tenofovir    Tenofovir disoproxil    Tenofovir Disoproxil Fumarate    Trizivir   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load. [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes [ Time Frame: 24 weeks ]

Estimated Enrollment:   100
Study Start Date:   March 2002

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038506

Show 62 study locations  Show 62 Study Locations

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials, MD     GlaxoSmithKline    
  More Information


Study ID Numbers:   ESS 30005
First Received:   May 31, 2002
Last Updated:   June 11, 2007
ClinicalTrials.gov Identifier:   NCT00038506
Health Authority:   United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HIV-1 TRIZIVIR Tenofovir  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Tenofovir
Lamivudine
Zidovudine
Abacavir
Retroviridae Infections
Immunologic Deficiency Syndromes
Tenofovir disoproxil

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 07, 2008




Links to all studies - primarily for crawlers