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Home > "A" Clinical Trials Conditions > A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients  A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients
A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: 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.
Details: Patients are randomized to receive ddI given either qd or bid in combination with d4T given bid (no doses specified).
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Documented HIV infection. - CD4 cell count of at least 100 cells/mm3. - Plasma HIV RNA count of 10,000 copies/ml or more within 14 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded: - Presence of a newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at the time of enrollment. - Bilateral peripheral neuropathy or signs and symptoms of bilateral peripheral neuropathy greater than or equal to Grade 2 at the time of screening. - Inability to tolerate oral medication. - Any other clinical condition that would preclude compliance with dosing requirements. Patients with the following prior conditions are excluded: - History of acute or chronic pancreatitis. - Intractable diarrhea (6 or more loose stools/day for more than 7 consecutive days) within 30 days prior to study entry. - 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. - Immunizations recommended by ACIP for routine practice. - 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. - Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry. Active alcohol or substance abuse that would prevent adequate compliance or would increase the risk of pancreatitis.
Total Enrollment:
Location and Contact Information:
Univ of Texas Med Branch
Galveston, Texas, 775550835
United States
Medicine Faculty Associates
Ypsilanti, Michigan, 48197
United States
Clinsites / Sorra Research Ctr
Birmingham, Alabama, 35203
United States
Dr Iraj Mirshahi
Richmond, Virginia, 23220
United States
Fanno Creek Clinic
Portland, Oregon, 97219
United States
ID Care Inc
Somerville, New Jersey, 08876
United States
Indiana Univ School of Medicine / Dept of Infect Dis
Indianapolis, Indiana, 46202
United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213
United States
Houston Clinical Research Network
Houston, Texas, 77006
United States
New Jersey Community Research Initiative
Newark, New Jersey, 07103
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Shared Med Research Foundation
Tarzana, California, 91356
United States
Additional Information:
Study ID Numbers: 039D; AI454-143
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002207
Other Hiv Infections Studies:
1. A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
2. The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections
3. Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
4. Dose ranging trial of tipranavir/ritonavir in treatment-experienced HIV infected individuals
5. A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC)
Related Studies:
Other HIV Infections Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients
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