Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy

Status unconfirmed · Phase 3

Conditions studied: HIV Infections

In brief

The purpose of this study is to compare GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.

Key facts

Study ID

NCT00008554

Run by

Glaxo Wellcome

People needed

210

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 required 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 (NNRT) or protease inhibitor (PI).
• Have a viral load (amount of HIV in the blood) of 5,000 copies/ml or more, or have a positive result at the screening visit.

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 the study, in the opinion of the doctor. Patients stable on methadone will be considered for participation.
• 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 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

• East Bay Clinical Trial Ctr — Concord, California, United States
• Ocean View Internal Medicine — Long Beach, California, United States
• Florida ID Group — Orlando, Florida, United States
• Hillsborough County Health Dept — Tampa, Florida, United States
• Clinical Pharmacology Services — Tampa, Florida, United States
• Veterans Affairs Med Ctr of North Chicago — Chicago, Illinois, United States
• Univ of Kansas Med Ctr — Kansas City, Kansas, United States
• Saint Michael's Med Ctr — Newark, New Jersey, United States
• UMDNJ - New Jersey Med School — Newark, New Jersey, United States
• Addiction Research and Treatment Corp — Brooklyn, New York, United States
• Brookdale Univ Hosp and Med Ctr — Brooklyn, New York, United States
• Gervais Frechette — New York, New York, United States
• Howard Grossman — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Univ of Rochester Med Ctr — Rochester, New York, United States
• Bronx Municipal Hosp Ctr/Jacobi Med Ctr — The Bronx, New York, United States
• SMO-USA Inc — Charlotte, North Carolina, United States
• Advanced Clinical Trials Inc — Eugene, Oregon, United States
• Thomas Jefferson Univ — Philadelphia, Pennsylvania, United States
• Univ of Texas Med Branch — Galveston, Texas, United States
• MacGregor Med Association — Houston, Texas, United States
• Walter Gaman — Irving, Texas, United States
• Southwest Texas Methodist Hosp — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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