Clinical trial NCT00197197: Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5/X4-Tropic Treatment-Experienced HIV-Infected Subjects
Official title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Compare the Efficacy and Safety of GW873140 400mg BID in Combination With a Ritonavir-containing Optimized Background Therapy (OBT) Regimen Versus Placebo Plus OBT Over 48 Weeks.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: HIV Infection
Keywords: HIV-1 GW873140 CCR5 antagonist treatment experienced
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 18
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: The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist GW873140 or placebo in combination with an optimized background regimen in treatment-experienced HIV-infected subjects with R5/X4-tropic virus


Eligibility criteria: Inclusion criteria:

* HIV-infected.
* Screening viral load at least 5000copies/mL.
* R5/X4-tropic virus at screening.
* Total prior antiretroviral experience of at least 3 months.
* Documented resistance to at least one drug in each of the following classes: nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), and protease inhibitors (PI), stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening.
* Able to receive a ritonavir-boosted protease inhibitor during treatment studies.
* Women of childbearing potential must use specific forms of contraception.

Exclusion criteria:

* Acute laboratory abnormalities.
* History of pancreatitis or hepatitis, hepatitis B or hepatitis C coinfection, or any chronic liver disease. Screening liver function tests will be used to determine eligibility.
* R5-tropic only.
* X4-tropic only.
* non-phenotypeable virus at screening.
* Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of treatment study.
* Pregnancy or breastfeeding women.
* Recent participation in an experimental drug trial.
* Prior use of a CCR5 or CXCR4 antagonist.
* Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, malabsorption disorders, cancer, or severe illness.
* Current use of certain medications may exclude participation in this study.
* Additional qualifying criteria and laboratory test requirements to be assessed by study physician.

Primary outcomes:
measure: HIV viral load response at 24 and 48 weeks.
timeFrame: 24 and 48 weeks
Secondary outcomes:
measure: Safety and tolerability, change in T-cell count, disease progression, viral resistance,tropism at failure, pharmacokinetics, health outcomes.Liver tests will be done every 2 weeks for 24 weeks.
timeFrame: every 2 weeks for 24 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Norwalk
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Hollywood
country: United States
facility: GSK Investigational Site
state: Florida
city: Plantation
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Newark
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, Ph.D.
role: STUDY_DIRECTOR
References: