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| Descriptive Information Fields | |||||
| Brief Title † | A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection | ||||
| Official Title † | A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection | ||||
| Brief Summary | To assess the magnitude and duration of the antiviral activity in plasma and the incidence and time to total suppression of detectable HIV RNA in plasma. To assess the long-term safety and tolerability of this combination therapy and the magnitude and duration of the effect of this therapy over CD4 cell counts. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | HIV Infections | ||||
| Intervention † | Drug: Hydroxyurea Drug: Nelfinavir mesylate Drug: Stavudine Drug: Didanosine |
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| MEDLINE PMIDs | |||||
| Links | BMS Clinical Trials Disclosure ![]() For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | |||||
| Start Date † | |||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded:
Patients with the following prior conditions are excluded: History of acute or chronic pancreatitis. 1. Use of potent neurotoxic drugs is not permitted.
Active alcohol or substance abuse. |
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00002176 | ||||
| Organization ID | 244C | ||||
| Secondary IDs †† | AI455-062 | ||||
| Study Sponsor † | Bristol-Myers Squibb | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Bristol-Myers Squibb | ||||
| Verification Date | October 2007 | ||||
| First Received Date † | November 2, 1999 | ||||
| Last Updated Date | October 1, 2007 | ||||