|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
| Study Start Date: | February 2004 |
| Study Completion Date: | February 2004 |
| Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
Patients are randomized to receive ddI given either qd or bid in combination with d4T given bid (no doses specified).
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 | |
| Principal Investigator: | . . | . |
More Information
| ClinicalTrials.gov Identifier: | NCT00002207 History of Changes |
| Other Study ID Numbers: | 039D, AI454-143 |
| Study First Received: | November 2, 1999 |
| Last Updated: | April 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Didanosine Drug Therapy, Combination Stavudine Reverse Transcriptase Inhibitors |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Didanosine |
Stavudine Reverse Transcriptase Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |