Comparison of Two Dosing Regimens of GW433908/Ritonavir Versus Lopinavir/Ritonavir for 48 Weeks in HIV Patients Who Have Taken Protease Inhibitors and Experienced Virological Failure

HIV Infections Clinical Trial

Official title:

A Phase III, Randomized, Multicenter, Parallel Group, Open-Label, Three Arm Study to Compare the Efficacy and Safety of Two Dosing Regimens of GW433908/Ritonavir (700mg/100mg Twice Daily or 1400mg/200mg Once Daily) Versus Lopinavir/Ritonavir (400mg/100mg Twice Daily) for 48 Weeks in Protease Inhibitor Experienced HIV-Infected Adults Experiencing Virological Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00025727
• Other study ID #: 316C
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 15, 2001
• Last updated: June 23, 2005
• Start date: May 2001

Study information

• Verified date: June 2002
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test 2 different dosing regimens of GW433908/ritonavir (RTV) versus lopinavir (LPV)/RTV when each is given with 2 active reverse transcriptase inhibitors (RTIs), in patients who have taken anti-HIV drugs without success.

Description:

Patients will receive 2 dosing regimens of GW433908/RTV or LPV/RTV, in combination with 2 active RTIs, after failing their first or second protease inhibitor-containing regimen. Patients are required to be on therapy at time of screening and must remain on this therapy until Day 1.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 330
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

Patients may be eligible for this study if they:

• Have a viral load of 1,000 or more copies/ml.

• Have taken protease inhibitors (PIs).

• Have taken PI drugs for at least 12 straight weeks and have had virologic failure on the PIs.

• Are now taking antiretroviral therapy.

• Are male or female and are at least 13 years old (or 18 if local requirement) and can provide consent from parent or guardian if under 18.

• Are females unable to have children or, if are able to have children, are not pregnant and agree to use approved birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have taken APV or LPV for more than 1 week.

• Have taken tenofovir disoproxil fumarate (TDF) or adefovir.

• Have taken more than 2 PIs.

• Are unable to take 2 active RTIs, as specified by the study.

• Have an active CDC Category C disease.

• Have certain abnormal laboratory tests.

• Are pregnant or breast-feeding.

• Have a serious health problem (e.g., diabetes, heart problems, hepatitis) that might risk the safety of the patient.

• Have a history of significant kidney or bone disease.

• Are not able to take drugs by mouth and cannot absorb them.

• Have had pancreatitis or hepatitis within the previous 6 months.

• Have a drug allergy or other allergy which might cause a problem during the study.

• Have had radiation or chemotherapy within 28 days of taking the study drug, or expect to need these during the study.

• Have taken drugs that affect the immune system (corticosteroids, interleukins, interferons) or drugs with anti-HIV activity (hydroxyurea or foscarnet) within 28 days prior to taking the study drug.

• Have had any HIV vaccine within 3 months before taking the study drug.

• Have taken certain other drugs within 28 days prior to taking the study drug, or expect to need them during the study.

• Use alcohol or illicit drugs in a way that the doctor feels would interfere with the study.

• Are not able to take the study drugs.

• Have inadequate kidney function.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lopinavir/Ritonavir

• Ritonavir

• GW433908

Locations

Country	Name	City	State
United States	Summa Health System	Akron	Ohio
United States	IDC Research Initiative	Altamonte Springs	Florida
United States	Med College of Georgia	Augusta	Georgia
United States	Boston Med Ctr / Evans - 556	Boston	Massachusetts
United States	Bach and Godofsky	Bradenton	Florida
United States	Rush Med College / Dept of Infectious Diseases	Chicago	Illinois
United States	Denver Inf Disease Consultants	Denver	Colorado
United States	Duke Univ Med Ctr	Durham	North Carolina
United States	Community Health Care	Fort Lauderdale	Florida
United States	North Broward Hosp District / HIV Clinical Research	Fort Lauderdale	Florida
United States	Therafirst Med Ctr	Fort Lauderdale	Florida
United States	Joseph Gathe	Houston	Texas
United States	Ocean View Internal Medicine	Long Beach	California
United States	Bisher Akil	Los Angeles	California
United States	Tower ID Med Associates	Los Angeles	California
United States	Methodist Healthcare	Memphis	Tennessee
United States	Abbott-Northwestern Hosp / Clinic 42	Minneapolis	Minnesota
United States	Gervais Frechette	New York	New York
United States	Orange Coast Med Group	Newport Beach	California
United States	Florida ID Group	Orlando	Florida
United States	Discovery Alliance Inc	Pensacola	Florida
United States	West Florida Clinical Research Ctr	Pensacola	Florida
United States	Phoenix Body Positive	Phoenix	Arizona
United States	Fanno Creek Clinic	Portland	Oregon
United States	Roger Williams Med Ctr	Providence	Rhode Island
United States	Virginia Commonwealth Univ	Richmond	Virginia
United States	Pacific Horizons Med Group	San Francisco	California
United States	South Jersey Infectious Diseases Inc	Somers Point	New Jersey
United States	ID Care Inc	Somerville	New Jersey
United States	Southampton Healthcare Inc	St. Louis	Missouri
United States	Garden State Infectious Diseases / E I P Kennedy Health Sys	Voorhees	New Jersey
United States	Physicans Home Service	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States,