GW873140 In Combination With Combivir In HIV Infected Subjects

HIV Infection Clinical Trial

Official title:

A PhaseIIb, 96 Week, Randomised, Partially Double-blinded, Multicentre, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00104429
• Other study ID #: 102881
• Status: Terminated
• Phase: Phase 2
• First received: February 28, 2005
• Last updated: May 25, 2017
• Start date: January 2005
• Est. completion date: January 2006

Study information

• Verified date: May 2017
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infection
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection
• Infection, Human Immunodeficiency Virus I

Intervention

Drug:
• GW873140

• Combivir

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Bruxelles
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
France	GSK Investigational Site	Levallois-Perret
France	GSK Investigational Site	Lyon Cedex 02
France	GSK Investigational Site	Nantes
France	GSK Investigational Site	Paris
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Wuerzburg	Bayern
Italy	GSK Investigational Site	Brescia	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Portugal	GSK Investigational Site	Coimbra
Portugal	GSK Investigational Site	Lisboa
Portugal	GSK Investigational Site	Porto
Spain	GSK Investigational Site	Madrid
United Kingdom	GSK Investigational Site	Birmingham	Warwickshire
United Kingdom	GSK Investigational Site	Brighton	Sussex East
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester	Lancashire
United States	GSK Investigational Site	Bakersfield	California
United States	GSK Investigational Site	Beverly Hills	California
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Conyers	Georgia
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newark	New Jersey
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Providence	Rhode Island
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Stanford	California
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tarzana	California
United States	GSK Investigational Site	Vero Beach	Florida
United States	GSK Investigational Site	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
ViiV Healthcare

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with viral loads <400 copies/mL remaining on randomized treatment through Week 12
Secondary	- 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.