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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002001
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: September 1991
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Zidovudine
Drug: Zalcitabine
Drug: Didanosine

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT00002001

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

Publications:
ClinicalTrials.gov Identifier: NCT00002001     History of Changes
Other Study ID Numbers: 052B, 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:
Zalcitabine
Didanosine
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Zidovudine

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

ClinicalTrials.gov processed this record on September 29, 2014