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| Sponsored by: |
Bristol-Myers Squibb |
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00002207 |
Purpose
The purpose of this study is to compare the effectiveness of taking didanosine (ddI) once a day plus stavudine (d4T) twice a day with taking ddI twice a day plus d4T twice a day. This study also examines the safety of giving ddI with d4T in the short-term.
| Condition | Intervention |
|
HIV Infections |
Drug: Stavudine Drug: Didanosine |
| MedlinePlus related topics: | AIDS |
| ChemIDplus related topics: | Didanosine Stavudine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | A Randomized, Double-Blind Study of the Antiviral Activity of Once-Daily and Twice-Daily Dosing of Didanosine in Combination With Twice-Daily Dosing of Stavudine in HIV-Infected Subjects |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Proven or suspected acute hepatitis within 30 days prior to study entry.
1. Potent neurotoxic drugs, such as vincristine and thalidomide.
Other anti-HIV therapy.
1. Prophylaxis for pneumocystis carinii pneumonia (PCP) is strongly recommended for patients with CD4 cell counts less than or equal to 200/mm3 or who have had a prior episode of PCP.
Erythropoietin and G-CSF are allowed if myelosuppression emerges on study.
1. Any antiretroviral therapy.
Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry.
1. Any prior antiretroviral therapy.
Active alcohol or substance abuse that would prevent adequate compliance or would increase the risk of pancreatitis.
Contacts and Locations| United States, Alabama | |||||
| Clinsites / Sorra Research Ctr | |||||
| Birmingham, Alabama, United States, 35203 | |||||
| United States, California | |||||
| Shared Med Research Foundation | |||||
| Tarzana, California, United States, 91356 | |||||
| United States, Indiana | |||||
| Indiana Univ School of Medicine / Dept of Infect Dis | |||||
| Indianapolis, Indiana, United States, 46202 | |||||
| United States, Michigan | |||||
| Medicine Faculty Associates | |||||
| Ypsilanti, Michigan, United States, 48197 | |||||
| United States, New Jersey | |||||
| New Jersey Community Research Initiative | |||||
| Newark, New Jersey, United States, 07103 | |||||
| ID Care Inc | |||||
| Somerville, New Jersey, United States, 08876 | |||||
| United States, Oregon | |||||
| Fanno Creek Clinic | |||||
| Portland, Oregon, United States, 97219 | |||||
| United States, Pennsylvania | |||||
| Anderson Clinical Research | |||||
| Pittsburgh, Pennsylvania, United States, 15213 | |||||
| United States, Texas | |||||
| Univ of Texas Southwestern Med Ctr of Dallas | |||||
| Dallas, Texas, United States, 75235 | |||||
| Univ of Texas Med Branch | |||||
| Galveston, Texas, United States, 775550835 | |||||
| Houston Clinical Research Network | |||||
| Houston, Texas, United States, 77006 | |||||
| United States, Virginia | |||||
| Hampton Roads Med Specialists | |||||
| Hampton, Virginia, United States, 23666 | |||||
| Dr Iraj Mirshahi | |||||
| Richmond, Virginia, United States, 23220 | |||||
| Bristol-Myers Squibb |
| Principal Investigator: | . . | . |
More Information
BMS Clinical Trials Disclosure 
  |
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm 
  |
| Study ID Numbers: | 039D, AI454-143 |
| First Received: | November 2, 1999 |
| Last Updated: | October 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00002207 |
| Health Authority: | United States: Food and Drug Administration |
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