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

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

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

Zidovudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison

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

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

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

Study ID Numbers:	014C, 013
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002023
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

Study placed in the following topic categories:

Virus Diseases

Signs and Symptoms

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Zidovudine

AIDS-Related Complex

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 16, 2008

Sponsored by:	Glaxo Wellcome
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002023