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GW873140 In Combination With Combivir In HIV Infected Subjects

This study has been terminated.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00104429
First received: February 28, 2005
Last updated: March 17, 2011
Last verified: March 2011

February 28, 2005
March 17, 2011
January 2005
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Proportion of subjects with viral loads <400 copies/mL remaining on randomized treatment through Week 12
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Complete list of historical versions of study NCT00104429 on ClinicalTrials.gov Archive Site
- Comparison of safety and tolerability of different dosage regimens of GW873140 plus Combivir to standard of care regimen. - Assessment of drug resistance over time. - Co-receptor tropism following virological failure.
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GW873140 In Combination With Combivir In HIV Infected Subjects
See Detailed Description

This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Combivir in HIV infected, untreated subjects.

A Phase IIb, 96 week, randomized, partially double-blinded, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of GW873140 in combination with Combivir (lamivudine and zidovudine) upon selected immunological and virological markers of HIV-1 infection in antiretroviral therapy naive adults

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Human Immunodeficiency Virus I Infection
  • HIV Infection
  • Drug: GW873140
  • Drug: Combivir
    Other Names:
    • GW873140
    • Combivir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
125
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Inclusion criteria:

  • HIV infected subjects.
  • Females must be of either non-childbearing age, or have a negative pregnancy test.
  • All subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study.
  • Screening lab result of plasma HIV-1 RNA greater than or equal to 10,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3.
  • Have CC Chemokine Receptor5-tropic (R5-tropic) virus based on viral tropism test at screening visit.
  • Have no drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit.
  • Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or a nucleoside reverse transcriptase inhibitor/nucleotide reverse transcriptase inhibitor (NRTI/ NtRTI), or less than or equal to 7 days of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI).
  • Prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) is not allowed.
  • Be able to understand and follow with protocol requirements, instructions and protocol-stated restrictions.
  • Signed and dated written informed consent prior to study entry.

Exclusion criteria:

  • Detection of any CXC Receptor4-tropic (X4-tropic) virus, based on viral tropism test at screening.
  • Any drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit.
  • Active Class C AIDS-defining illness.
  • Laboratory abnormalities at screen.
  • Significant blood loss prior to study start.
  • Pregnant or breastfeeding women.
  • Additional qualifying criteria to be determined by the physician.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   France,   Germany,   Italy,   Portugal,   Spain,   United Kingdom
 
NCT00104429
102881
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Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
March 2011

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