The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease

June 23, 2005 updated by: Glaxo Wellcome
To evaluate the virologic effect of combined administration of zidovudine and ddI or ddC. To evaluate the immunologic effects of zidovudine and ddI or ddC. To evaluate combined administration of zidovudine and ddI or ddC for clinical efficacy. To evaluate the safety and the tolerance of the coadministration of zidovudine and ddI or ddC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Darlinghurst, Australia
        • Saint Vincent's Hosp Med Centre
  • Puerto Rico
      • San Juan, Puerto Rico, 009275800
        • San Juan Veterans Administration Med Ctr
  • United States
    • Colorado
      • Denver, Colorado, United States, 80262
        • Univ of Colorado Health Sciences Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr / Main Hosp 4
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Patients with PCP may be randomized to study medication after contacting the sponsor and following a minimum 7-day course of therapy resulting in stabilization of their disease. Patients with stabilized disease must have fever < 39 C for at least 48 hours, p02 (on room air) > or = 60 mm and an A/A gradient < or = 30 mm.
  • Prophylaxis for PCP.

Patients must have the following:

  • HIV-1 seropositive by any federally licensed ELISA.
  • Willingness to give informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Any immediately life-threatening infection or medical condition present at time of study entry.
  • Any active opportunistic infection requiring chronic therapy with any of the agents listed in the exclusion concurrent medication section.
  • Neoplasms other than basal cell carcinoma or in situ carcinoma of the cervix.
  • Kaposi's sarcoma with visceral involvement or requiring systemic cytotoxic chemotherapy.
  • AIDS dementia complex, > or = Stage 2.
  • History of zidovudine induced toxicity.
  • Prior history of acute pancreatitis during the past two years or chronic pancreatitis.
  • Grade 2 neuropathy.
  • Intractable diarrhea.
  • History of seizures within the past six months or current requirement of anticonvulsants.
  • Past or current heart disease.
  • Fever > 39 C at entry.

Concurrent Medication:

Current requirement of anticonvulsants.

  • Excluded:
  • It is intended that patients developing new opportunistic infections during the course of the study will continue study participation, unless required therapy is associated with significant neurologic or hematologic toxicities, in which case the study medication may be temporarily discontinued.
  • Ganciclovir.
  • Chloramphenicol.
  • Cisplatinum.
  • Iodoquinol.
  • Systemic Pentamidine.
  • Disulfiram.
  • Ethionamide.
  • Glutethimide.
  • Gold.
  • Hydralazine.
  • Metronidazole.
  • Sodium Cyanate.
  • Thalidomide.
  • Vincristine.
  • Allopurinol.
  • Probenecid.

Concurrent Treatment:

Excluded:

  • Radiation therapy. (with the exception of electron beam therapy to an area of < 100cm/m2.)

Patients with the following are excluded:

  • Any immediately life-threatening infection or medical condition present at time of study entry.
  • Any active opportunistic infection requiring chronic therapy with any of the agents listed in the exclusion concurrent medication section.
  • Active alcohol or drug abuse, sufficient in the investigator's opinion to prevent compliance with study therapy.
  • Neoplasms other than basal cell carcinoma or in situ carcinoma of the cervix.
  • Kaposi's syndrome with visceral involvement or requiring systemic cytotoxic chemotherapy.
  • AIDS dementia complex, > or = Stage 2.
  • History of zidovudine induced toxicity.
  • Any experimental therapy within 30 days.
  • Prior history of acute pancreatitis during the past two years or chronic pancreatitis.
  • Grade 2 neuropathy.
  • Intractable diarrhea.
  • History of seizures within the past six months or current requirement of anticonvulsants.
  • History of past or current heart disease.
  • Fever > 39 C at entry.

Prior Medication:

Excluded:

  • Any anti-HIV therapy (other than zidovudine), biologic response modifiers, or pharmacologic doses of corticosteroids within eight weeks of entry (except for the management of severe PCP, in which case duration is not to exceed 21 days).
  • Zidovudine therapy for greater than four weeks or prior discontinuation due to drug toxicity.
  • Prior therapy with ddI, ddC, D4T, or interferon.
  • Any experimental therapy within 30 days.
  • Therapy within 30 days with neurotoxic drugs.

Prior Treatment:

Excluded:

  • Radiation therapy within two weeks of entry or likely to require radiation therapy (with the exception of electron beam therapy to an area of < 100cm/m2).

Active alcohol or drug abuse, sufficient in the investigator's opinion, to prevent compliance with study therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaxo Wellcome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

September 1, 1991

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 052B
  • 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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