ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
An Oral Dose-Ranging Finding Study in Patients With HIV Disease, CDC Classification Groups IIB, III, and IV-C2

This study has been completed.
Study NCT00002023.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  An Oral Dose-Ranging Finding Study in Patients With HIV Disease, CDC Classification Groups IIB, III, and IV-C2
Official Title  An Oral Dose-Ranging Finding Study in Patients With HIV Disease, CDC Classification Groups IIB, III, and IV-C2
Brief Summary

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.

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Treatment, Dose Comparison
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Zidovudine
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
Eligibility 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.

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002023
Organization ID 014C
Secondary IDs †† 013
Study Sponsor  Glaxo Wellcome
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date February 1995
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers