GW873140 In Combination With Combivir In HIV Infected Subjects - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00104429

Purpose

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.

Condition	Intervention	Phase
Human Immunodeficiency Virus I Infection HIV Infection	Drug: GW873140 Drug: Combivir	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	See Detailed Description

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Combivir Aplaviroc

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

- 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.

Estimated Enrollment:	125
Study Start Date:	January 2005

Intervention Details:

Other Names:

GW873140
Combivir

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

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104429

Show 51 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00104429 History of Changes
Other Study ID Numbers:	102881
Study First Received:	February 28, 2005
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

HIV infections
therapy naive

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

Lamivudine, zidovudine drug combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 09, 2012