Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs

Status unconfirmed · Phase 3

Conditions studied: HIV Infections

In brief

The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.

Key facts

Study ID

NCT00009061

Run by

Glaxo Wellcome

People needed

624

Starts

2000-11-01

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:
• Are at least 13 years old (consent of parent or guardian needed if under 18).
• Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children.
• Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Mothers who have previously received 1 dose of the NNRTI nevirapine during pregnancy for prevention of mother-to-child HIV transmission are permitted to enter the study.
• Have a viral load (amount of HIV in the blood) of 1,000 copies/ml or more.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Abuse drugs or alcohol in a way that would interfere with study requirements. Patients who are stable on methadone will be considered for the study.
• Have an active/acute CDC Category C event.
• Are unable to absorb or take medicines by mouth.
• Are pregnant or breast-feeding.
• Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient.
• Have had pancreatitis or hepatitis within the last 6 months.
• Have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study.
• Have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken.
• Have received an HIV vaccine within 3 months before the study drug will be taken.
• Have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study.
• Have received experimental treatments.
• Have allergies which might interfere with the study, in the opinion of the doctor.

Where it is running

• Orange County Ctr for Special Immunology — Fountain Valley, California, United States
• AIDS Healthcare Foundation — Los Angeles, California, United States
• LAGLC — Los Angeles, California, United States
• Kaiser Hospital — Sacramento, California, United States
• Park Ctr for Health / Keith Vrhel — San Diego, California, United States
• AIDS Research Alliance — West Hollywood, California, United States
• Dupont Circle Physicians Group — Washington D.C., District of Columbia, United States
• Infectious Disease Consultants — Altamonte Springs, Florida, United States
• CRI of South Florida — Coral Gables, Florida, United States
• Therafirst Med Ctr — Fort Lauderdale, Florida, United States
• Gary Richmond MD — Fort Lauderdale, Florida, United States
• Univ of Miami Dept of Medicine — Miami, Florida, United States
• Specialty Med Care Ctrs of South Florida Inc — Miami, Florida, United States
• Infectious Diseases Associates — Sarasota, Florida, United States
• Jeffrey Levenson — St. Petersburg, Florida, United States
• Infectious Disease Research Inst — Tampa, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Med College of Georgia — Augusta, Georgia, United States
• SMO USA — Conyers, Georgia, United States
• Indiana Univ Med School — Indianapolis, Indiana, United States
• Brigham and Women's Hosp — Boston, Massachusetts, United States
• Hawthorne Med Associates / PAACA — New Bedford, Massachusetts, United States
• Abbott-Northwestern Hosp / Clinic 42 — Minneapolis, Minnesota, United States
• Southampton Healthcare Inc — St Louis, Missouri, United States
• VAMC New Jersey Healthcare System — East Orange, New Jersey, United States

Full record on ClinicalTrials.gov

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