- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002023
An Oral Dose-Ranging Finding Study in Patients With HIV Disease, CDC Classification Groups IIB, III, and IV-C2
June 23, 2005 updated by: Glaxo Wellcome
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.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
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
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North Carolina
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Research Triangle Park, North Carolina, United States, 27709
- Glaxo Wellcome Inc
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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
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
February 1, 1995
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Zidovudine
Other Study ID Numbers
- 014C
- 013
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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