A Comparison of Two Dose Levels of Didanosine Used in Combination With Stavudine in HIV-Infected Patients
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
2 other identifiers
interventional
N/A
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2004
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedApril 25, 2011
April 1, 2011
Same day
November 2, 1999
April 13, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- \. Potent neurotoxic drugs, such as vincristine and thalidomide.
- Other anti-HIV therapy.
- \. 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
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
Related Publications (1)
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. doi: 10.1097/00002030-199907300-00003.
PMID: 10449279BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Start
February 1, 2004
Primary Completion
February 1, 2004
Study Completion
February 1, 2004
Last Updated
April 25, 2011
Record last verified: 2011-04