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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 28, 2005

Last Updated Date

March 17, 2011

Start Date ^ICMJE

January 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Proportion of subjects with viral loads <400 copies/mL remaining on randomized treatment through Week 12

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00104429 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

- 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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

GW873140 In Combination With Combivir In HIV Infected Subjects

Official Title ^ICMJE

See Detailed Description

Brief Summary

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.

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Human Immunodeficiency Virus I Infection
HIV Infection

Intervention ^ICMJE

Drug: GW873140
Drug: Combivir
Other Names:
- GW873140
- Combivir

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

125

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Canada, France, Germany, Italy, Portugal, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00104429

Other Study ID Numbers ^ICMJE

102881

Has Data Monitoring Committee

Responsible Party

Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

March 2011

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

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