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An Oral Dose-Ranging Finding Study in Patients With HIV Disease, CDC Classification Groups IIB, III, and IV-C2

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002023
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1995
  Purpose

To establish the relationship between the oral dose of zidovudine (AZT) and its hematologic toxicity. AZT has preliminarily been shown to decrease significant events and death in a group of AIDS / Pneumocystis carinii pneumonia (PCP) and AIDS related complex (ARC) patients followed at this time for a limited period. If these data withstand further follow-up, it appears that AZT is a potential antiretroviral agent that may have application in the use of all stages of HIV disease. At this time the optimal dose that will not cause significant toxicity is not known. If this drug has widespread application, it becomes imperative to further study both the dose and the toxicity. Patients with documented HIV viremia and who are well will be evaluated in a dose-escalating protocol for toxicity, persistent viremia, evidence of improvement of immune dysfunction, and the development of further manifestation of HIV disease. Drug levels will be monitored and correlated with the toxicity and viremia.


Condition Intervention
HIV Infections
Drug: Zidovudine

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: An Oral Dose-Ranging Finding Study in Patients With HIV Disease, CDC Classification Groups IIB, III, and IV-C2

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

Patients must have HIV reactivity.

  • Patients must belong to one of the following three groups according to the CDC classification:
  • IIB - including only those patients with autoimmune thrombocytopenia (platelet count = or < 100000 platelets/mm3).
  • OR Lymphopenia (lymphocyte count = or < 1000 cells/mm3).
  • OR Helper cell lymphopenia (helper cells < the mean of normals).
  • OR CDC classification III or IV-C2.
  • Patients with = or < involuntary 10 percent weight loss in the last 6 months.
  • ECOG performance status 0 or 1.
  • Weigh 70 kg + or - 15 kg in order to standardize the g/kg dosing.
  • Positive antibody for HIV by an ELISA test kit. If the ELISA is negative, then eligibility will be confirmed by second confirmatory test, i.e., immunoblot.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • AIDS or the CDC classification stage IV except stage IV-C2.
  • HIV antibody negative by immunoblot.
  • Persistent fevers of > 38.5 degrees C.
  • Persistent diarrhea undiagnosed > 1 month.
  • Involuntary weight loss of > 10 percent in the 6 months prior to study entry.
  • ECOG performance status of 2, 3, or 4.
  • Class IV-C2 with prior history of:
  • Multidermal herpes zoster.
  • Oral candidiasis on more than one occasion.
  • Tuberculosis.

Concurrent Medication:

Excluded:

  • Other antiretroviral agents.
  • Active immunomodulating agents.
  • Any other experimental therapy.
  • Drugs which cause anemia or neutropenia.
  • Drugs which are glucuronidated and may interfere with the metabolism of AZT, i.e., acetaminophen > 5 days.
  • Acyclovir systemically administered > 5 days.
  • Any other experimental agents.

Patients with the following are excluded:

  • AIDS or the CDC classification stage IV except stage IV-C2.
  • HIV antibody negative by immunoblot.
  • Persistent fevers of > 38.5 degrees C.
  • Persistent diarrhea undiagnosed > 1 month.
  • Involuntary weight loss of > 10 percent in the 6 months prior to study entry.
  • ECOG performance status of 2, 3, or 4.
  • Class IV-C2 with prior history of:
  • Multidermal herpes zoster.
  • Oral candidiasis on more than one occasion.
  • Tuberculosis.

Prior Medication:

Excluded within 3 months of study entry:

  • Other antiretroviral agents. Active immunomodulating agents.
  • Excluded within 2 weeks of study entry:
  • Drugs which cause anemia or neutropenia.
  • Drugs which are glucuronidated and may interfere with the metabolism of zidovudine (AZT), i.e., acetaminophen > 5 days.
  • Acyclovir systemically administered > 5 days.
  • Any other experimental agents.

Known active drug abuse.

  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: NCT00002023

Locations
United States, North Carolina
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002023     History of Changes
Other Study ID Numbers: 014C, 013
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:
Dose-Response Relationship, Drug
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
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
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014