A Phase I Study to Evaluate the Pharmacokinetics, Safety and Antiviral Effects of Concurrent Administration of Zidovudine (AZT) and 2'3'-Dideoxyinosine (ddI) in Patients With Human Immunodeficiency Virus (HIV)

June 23, 2005 updated by: Glaxo Wellcome
To determine the safety and tolerance of various combinations of zidovudine (AZT) and didanosine (ddI) administered concurrently. To determine the pharmacokinetics of concurrent AZT and ddI administered orally. To evaluate the antiviral, immunologic and virologic effects of AZT and ddI administered concurrently.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

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

  • United States
    • California
      • San Francisco, California, United States, 941102859
        • San Francisco AIDS Clinic / San Francisco Gen Hosp
    • Florida
      • Miami, Florida, United States, 331361013
        • Univ of Miami School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Med Ctr
    • Washington
      • Seattle, Washington, United States, 981224304
        • Univ of Washington

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Acyclovir not to exceed two 14-day courses of therapy during trial. Discontinue ddI while receiving acyclovir.

Patients must have the following:

  • Positive HIV antibody using federally licensed ELISA test kit.
  • CD4 counts < 400 on two consecutive visits within one month prior to entry.

Prior Medication:

Allowed:

  • Zidovudine (AZT) if treated for less than 120 days.
  • Pharmacologic doses of steroids if given for management of Pneumocystis carinii pneumonia (PCP) (not to exceed 21 days).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Visceral or progressive Kaposi's sarcoma (KS) (defined by > 10 new lesions in the thirty days prior to entry) or patients who require chemotherapy or radiation therapy for Kaposi's sarcoma. Other concurrent neoplasms other than basal cell carcinoma of skin or in situ carcinoma of the cervix. Malabsorption as defined by persistent diarrhea ( > 4 stools/day for four weeks) which is unresponsive to antidiarrheal agents. Opportunistic infection requiring maintenance therapy. History of Central Nervous System opportunistic infections (e.g., toxoplasmosis, cryptococcosis). History of seizure disorders. Prior history of pancreatitis. History of peripheral neuropathy or any significant signs or symptoms of neurological disease. Examinations for peripheral neuropathy should assess changes in extremities. Clinically significant hyperuricemia (tophaceous gout, urate nephropathy). History of cardiomyopathy.

Concurrent Medication:

Excluded:

  • Intravenous pentamidine.
  • Intravenous trimethoprim / sulfamethoxazole.
  • Alcohol.
  • Suppressive acyclovir therapy (see Inclusion Medications).
  • Allopurinol.
  • Probenecid.
  • Isoniazid (INH).
  • Dipyridamole.

Concurrent Treatment:

Excluded:

  • Radiation therapy for Kaposi's sarcoma.

Patients with the following are excluded:

  • Zidovudine (AZT) intolerance as evidenced by inability to tolerate at least 600 mg AZT daily.
  • Previously intolerant to didanosine (ddI) evidenced by peripheral neuropathy or seizures or pancreatitis or gastrointestinal toxicity or hematologic toxicity.
  • Diseases or conditions listed under Patient Exclusion Co-existing Conditions.

Prior Medication:

Excluded:

  • Zidovudine (AZT) for > 120 days.
  • Dideoxycytidine (ddC).
  • Excluded within 30 days of study entry:
  • Antiretroviral therapy.
  • Immunomodulators.
  • Biological response modifiers.
  • Cytotoxic chemotherapy for Kaposi's sarcoma.
  • Excluded within 60 days of study entry:
  • Ribavirin.

Prior Treatment:

Excluded within 2 weeks of study entry:

  • Transfusions.
  • Excluded within 30 days of study entry:
  • Radiation therapy for Kaposi's sarcoma.

Active substance abuse that would impair compliance with study procedures.

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

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

August 1, 1991

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 052A
  • 01 (Miami VAHS)

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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