GW873140 In Combination With Kaletra In HIV Infected Subjects

HIV Infection Clinical Trial

Official title:

A Phase IIb, 96 Week, Randomized, Open-label Multicenter, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of Different Doses and Regimens of GW873140 in Combination With Kaletra (Lopinavir and Ritonavir) in HIV-1 Infected Antiretroviral Therapy naïve Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00102778
• Other study ID #: 100136
• Status: Terminated
• Phase: Phase 2
• First received: February 1, 2005
• Last updated: May 25, 2017
• Start date: December 2004
• Est. completion date: September 2007

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 Kaletra in HIV infected, untreated subjects.

Description:

A Phase IIb, 96 week, randomized, open-label, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of different doses and regimens of GW873140 in combination with Kaletra (lopinavir and ritonavir) in HIV-1 infected antiretroviral therapy naive subjects

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 175
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• HIV infected, therapy-naive 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 50,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3.

• Have CC Chemokine Receptor5-tropic (R5-tropic) or CC Chemokine Receptor5/CXC Chemokine Receptor4-tropic (R5/X4-tropic) virus based on viral tropism test at screening visit.

• Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or an 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:

• No detection of CXC Receptor4-tropic (X4-tropic) virus only, based on viral tropism test at screening.

• No active Class C AIDS-defining illness.

• No laboratory abnormalities at screen.

• No significant blood loss prior to study start.

• No 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

• Kaletra (lopinavir/ritonavir)

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Vancouver	British Columbia
Denmark	GSK Investigational Site	Hvidovre
Denmark	GSK Investigational Site	Koebenhavn
France	GSK Investigational Site	Le Kremlin Bicêtre Cedex
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Nantes
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris Cedex 10
France	GSK Investigational Site	Paris Cedex 12
France	GSK Investigational Site	Paris Cedex 13
France	GSK Investigational Site	Paris Cedex 14
France	GSK Investigational Site	Paris Cedex 20
France	GSK Investigational Site	Saint Denis Cedex 01
France	GSK Investigational Site	Tourcoing
France	GSK Investigational Site	Villejuif Cedex
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Torino	Piemonte
Netherlands	GSK Investigational Site	Amsterdam
Portugal	GSK Investigational Site	Cascais
Portugal	GSK Investigational Site	Lisboa
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Sevilla
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	Allentown	Pennsylvania
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Bradenton	Florida
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fort Myers	Florida
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Hampton	Virginia
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Jackson	Mississippi
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Santa Fe	New Mexico
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Washington, D.C.	District of Columbia
United States	GSK Investigational Site	Washington, D.C.	District of Columbia
United States	GSK Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ViiV Healthcare

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  France,  Germany,  Italy,  Netherlands,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To select a GW873140 dose and dosage regimen for further evaluation based on comparison of the short-term antiviral activity, safety and tolerability of different oral doses of GW873140 in combination with LPV/r in HIV-1 infected therapy-naive subjects.
Secondary	HIV-1 RNA decay rate Long-term safety Effects on plasma viral tropismViral resistance to GW873140 and other on-study drugsPK parameters of GW873140 in subjects receiving combination therapy.