The Safety and Effectiveness of 935U83 in HIV-Infected Patients

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To assess the safety, tolerance, and steady-state pharmacokinetics of multiple oral doses of 935U83 administered to patients with HIV infection. To obtain preliminary evidence of antiretroviral activity of 935U83. To prospectively evaluate the emergence of in vitro drug resistance. To determine the effects of 935U83 dosing on CD4+ cell counts.

Key facts

Study ID

NCT00002338

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…

• Concurrent Medication:
• Recommended:
• PCP prophylaxis for patients whose CD4 counts fall below 200 cells/mm3 or who develop PCP during study participation.
• Allowed:
• Acute treatment and secondary prophylaxis for tuberculosis, Mycobacterium avium intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection.
• Patients must have:
• HIV infection.
• CD4 count 200 - 500 cells/mm3.
• No history of or current AIDS-defining indicator disease by CDC criteria.
• No antiretroviral therapy within the past 6 months.
• Consent of parent or guardian if less than 18 years of age.

You may not qualify if…

• Co-existing Condition:
• Patient with the following symptoms or conditions are excluded:
• Current evidence of chronic hepatitis of any etiology.
• Seropositivity for HBsAg or hepatitis C virus by second generation ELISA.
• Concurrent Medication:
• Excluded:
• Cytotoxic chemotherapy.
• Other antiretroviral drugs.
• Immunomodulators.
• Foscarnet.
• GM-CSF or G-CSF.
• Erythropoietin.
• Concurrent Treatment:
• Excluded:
• Radiation therapy.
• Patients with the following prior conditions are excluded:
• History of chemical, viral, or alcohol-induced clinical hepatitis within the past 3 years.
• Prior Medication:
• Excluded within the past 6 months:
• Any antiretroviral therapy.
• HIV immunotherapeutic vaccine.
• Excluded within the past 4 weeks:
• Cytotoxic chemotherapy.
• Immunomodulating agents such as systemic corticosteroids, IL-2, alpha interferon, beta interferon, or gamma interferon.
• Prior Treatment:

Where it is running

• ViRx Inc — San Francisco, California, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Goodgame Med Group — Maitland, Florida, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Univ of Cincinnati / Holmes Hosp — Cincinnati, Ohio, United States
• Univ of Pittsburgh Med School — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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