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)

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002014
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1991
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Zidovudine
Drug: Didanosine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002014

Locations
United States, California
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Massachusetts
New England Med Ctr
Boston, Massachusetts, United States, 02111
United States, Washington
Univ of Washington
Seattle, Washington, United States, 981224304
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002014     History of Changes
Other Study ID Numbers: 052A, 01
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:
Didanosine
Drug Evaluation
Zidovudine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Antiviral Agents
Didanosine
Zidovudine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 15, 2014