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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002338
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Raluridine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
Official Title: A Phase I Trial to Evaluate the Safety, Tolerance, and Pharmacokinetics of 935U83 After Multiple Dosing in Patients With HIV Infection

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 40
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002338

Locations
United States, California
ViRx Inc
San Francisco, California, United States, 94103
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
United States, Florida
Goodgame Med Group
Maitland, Florida, United States, 32751
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
United States, Ohio
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
Glaxo Wellcome
  More Information

Publications:
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

ClinicalTrials.gov Identifier: NCT00002338     History of Changes
Other Study ID Numbers: 237A, 02
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014