A Study of 1592U89 Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs

Completed · Phase 2

Conditions studied: HIV Infections

In brief

To obtain preliminary evidence of antiretroviral activity of 1592U89 when administered in combination with other specific NRTI agents in NRTI experienced patients and to assess the safety and tolerance of multiple oral doses of 1592U89 when administered in combination with specific marketed NRTIs.

Key facts

Study ID

NCT00002364

Run by

Glaxo Wellcome

People needed

40

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 must have:
• CD4+ cell count >= 100 /mm3.
• Plasma HIV RNA >= 30,000 copies/ml.
• Study participants may be recruited from all clinical categories, provided they do not meet any of the exclusion criteria.
• Parent or legal guardian to sign written, informed consent for patients under the age of 18.

You may not qualify if…

• Co-existing Condition:
• Patients with any of the following symptoms or conditions are excluded:
• Patients with active or ongoing AIDS-defining opportunistic infection or disease. NOTE:
• For this study, a CD4+ cell count <= 200 cells/mm3 in the absence of any other AIDS defining indicator condition is not considered an AIDS defining event.
• Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption.
• Patients with life threatening infection or other serious medical conditions whose participation may compromise patient safety.
• Concurrent Medication:
• Excluded:
• Treatment with cytotoxic chemotherapeutic agents within the 24 weeks of the study.
• Patients receiving other investigational drugs.
• Foscarnet therapy or therapy with other agents with documented activity against HIV in vitro.
• Treatment with immunomodulators.
• Patients on methadone.
• Concurrent Treatment:
• Excluded:
• Treatment with radiation therapy within the 24 weeks of the study. NOTE:
• Localized radiation therapy may be permitted following consultation with the sponsor.
• Patients with any of the following prior conditions are excluded:
• Subjects with a history of lymphoma.
• Subjects with a history of clinically apparent pancreatitis or hepatitis within the last 6 months.
• Prior Medication:
• Excluded:
• Treatment with any antiretroviral therapy with NRTIs (alone or in combination) other than those defined for each treatment group.
• Treatment with any non-nucleoside RT inhibitors or protease inhibitors.
• Treatment with cytotoxic chemotherapeutic agents within 1 month prior to study entry.

Where it is running

• Marin County Specialty Clinic — Greenbrae, California, United States
• Kraus Med Partners — Los Angeles, California, United States
• ViRx Inc — San Francisco, California, United States
• IDC Research Initiative — Altamonte Springs, Florida, United States
• North Broward Hosp District — Fort Lauderdale, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Univ of Kentucky Med Ctr — Lexington, Kentucky, United States
• Beth Israel Med Ctr — New York, New York, United States

Full record on ClinicalTrials.gov

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