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

HIV Infections Clinical Trial

Official title:

A Phase I Trial to Evaluate the Safety, Tolerance, and Pharmacokinetics of 935U83 After Multiple Dosing in Patients With HIV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002338
• Other study ID #: 237A
• Secondary ID: 02
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

Drug:
• Raluridine

Locations

Country	Name	City	State
United States	Univ of Cincinnati / Holmes Hosp	Cincinnati	Ohio
United States	Duke Univ Med Ctr	Durham	North Carolina
United States	Indiana Univ Hosp	Indianapolis	Indiana
United States	Goodgame Med Group	Maitland	Florida
United States	Univ of Pittsburgh Med School	Pittsburgh	Pennsylvania
United States	ViRx Inc	San Francisco	California
United States	Georgetown Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States, 

References & Publications (1)

Riddler SA, McMahon DK, Bartlett JA, Savina PM, Wang LH, Dunn JA, Mellors JW. A phase I single-dose trial to evaluate the safety and pharmacokinetics (PK) of 5-chloro-2'3'-dideoxy- 3'fluorouridine (935U83). Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:160