A Comparison of Two Dose Levels of Didanosine Used in Combination With Stavudine in HIV-Infected Patients
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Stavudine (Drug); Didanosine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
. ., Principal Investigator, Affiliation: .
Summary
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Detailed description:
Patients are randomized to receive ddI given either qd or bid in combination with d4T given
bid (no doses specified).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Clinsites / Sorra Research Ctr, Birmingham, Alabama 35203, United States
Shared Med Research Foundation, Tarzana, California 91356, United States
Indiana Univ School of Medicine / Dept of Infect Dis, Indianapolis, Indiana 46202, United States
Medicine Faculty Associates, Ypsilanti, Michigan 48197, United States
New Jersey Community Research Initiative, Newark, New Jersey 07103, United States
ID Care Inc, Somerville, New Jersey 08876, United States
Fanno Creek Clinic, Portland, Oregon 97219, United States
Anderson Clinical Research, Pittsburgh, Pennsylvania 15213, United States
Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas 75235, United States
Univ of Texas Med Branch, Galveston, Texas 775550835, United States
Houston Clinical Research Network, Houston, Texas 77006, United States
Hampton Roads Med Specialists, Hampton, Virginia 23666, United States
Dr Iraj Mirshahi, Richmond, Virginia 23220, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Related publications: Mobley JE, Pollard RB, Schrader S, Adler MH, Kelleher T, McLaren C. Virological and immunological responses to once-daily dosing of didanosine in combination with stavudine. AI454-143 Team. AIDS. 1999 Jul 30;13(11):F87-93.
Starting date: February 2004
Ending date: February 2004
Last updated: October 1, 2007
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