Clinical trial NCT00102778: GW873140 In Combination With Kaletra In HIV Infected Subjects
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Infection, Human Immunodeficiency Virus I
HIV Infection
Keywords: HIV infected
therapy-naive subjects
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2005-02-02
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: 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 outcomes:
measure: 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.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Washington, D.C.
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Washington, D.C.
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Bradenton
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Jackson
country: United States
facility: GSK Investigational Site
state: Mississippi
city: Santa Fe
country: United States
facility: GSK Investigational Site
state: New Mexico
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Allentown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Hampton
country: United States
facility: GSK Investigational Site
state: Virginia
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sainte-Foy
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Hvidovre
country: Denmark
facility: GSK Investigational Site
city: Koebenhavn
country: Denmark
facility: GSK Investigational Site
city: Le Kremlin Bicêtre Cedex
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: GSK Investigational Site
city: Nantes
country: France
facility: GSK Investigational Site
city: Paris Cedex 10
country: France
facility: GSK Investigational Site
city: Paris Cedex 12
country: France
facility: GSK Investigational Site
city: Paris Cedex 13
country: France
facility: GSK Investigational Site
city: Paris Cedex 14
country: France
facility: GSK Investigational Site
city: Paris Cedex 20
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Saint Denis Cedex 01
country: France
facility: GSK Investigational Site
city: Tourcoing
country: France
facility: GSK Investigational Site
city: Villejuif Cedex
country: France
facility: GSK Investigational Site
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Torino
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Cascais
country: Portugal
facility: GSK Investigational Site
city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Brighton
country: United Kingdom
facility: GSK Investigational Site
state: Sussex East
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: