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

NCT ID: NCT00002338

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL

Brief Summary

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.

Detailed Description

Patients (10 per dose level) are randomized to receive 1 of 4 doses of 935U83 every 8 hours for 12 weeks. Five patients at each dose level must complete 4 weeks of treatment without serious toxicity before subsequent patients are entered at the next higher dose. If lack of antiretroviral effect or unacceptable toxicity is demonstrated at a particular dose level, the dose regimens may be adjusted.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Raluridine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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:

Excluded within the past 4 weeks:

• Radiation therapy. Current alcohol or illicit drug use that may interfere with study compliance.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glaxo Wellcome

INDUSTRY

Sponsor Role: lead

Locations

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

Countries

United States

References

Riddler SA, Wang LH, Bartlett JA, Savina PM, Packard MV, McMahon DK, Blum MR, Dunn JA, Elkins MM, Mellors JW. Safety and pharmacokinetics of 5-chloro-2',3'-dideoxy-3'-fluorouridine (935U83) following oral administration of escalating single doses in human immunodeficiency virus-infected adults. Antimicrob Agents Chemother. 1996 Dec;40(12):2842-7. doi: 10.1128/AAC.40.12.2842.

Reference Type: BACKGROUND

PMID: 9124852 (View on PubMed)

Other Identifiers

02

Identifier Type: -

Identifier Source: secondary_id

237A

Identifier Type: -

Identifier Source: org_study_id