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| 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.
Exclusion Criteria Co-existing Condition: Patients with the following are excluded:
Concurrent Medication: Excluded:
Patients with the following are excluded:
Prior Medication: Excluded within 3 months of study entry:
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 |