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

Status unconfirmed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00025727

Run by

GlaxoSmithKline

People needed

330

Starts

2001-05-01

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Phoenix Body Positive — Phoenix, Arizona, 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
• Orange Coast Med Group — Newport Beach, California, United States
• Pacific Horizons Med Group — San Francisco, California, United States
• Denver Inf Disease Consultants — Denver, Colorado, United States
• Physicans Home Service — Washington D.C., District of Columbia, United States
• IDC Research Initiative — Altamonte Springs, Florida, United States
• Bach and Godofsky — Bradenton, Florida, United States
• Community Health Care — Fort Lauderdale, Florida, United States
• Therafirst Med Ctr — Fort Lauderdale, Florida, United States
• North Broward Hosp District / HIV Clinical Research — Fort Lauderdale, Florida, 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
• Med College of Georgia — Augusta, Georgia, United States
• Rush Med College / Dept of Infectious Diseases — Chicago, Illinois, United States
• Boston Med Ctr / Evans - 556 — Boston, Massachusetts, United States
• Abbott-Northwestern Hosp / Clinic 42 — Minneapolis, Minnesota, United States
• Southampton Healthcare Inc — St Louis, Missouri, United States
• South Jersey Infectious Diseases Inc — Somers Point, New Jersey, United States
• ID Care Inc — Somerville, New Jersey, United States
• Garden State Infectious Diseases / E I P Kennedy Health Sys — Voorhees Township, New Jersey, United States
• Gervais Frechette — New York, New York, United States

Full record on ClinicalTrials.gov

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