A Comparison of Two Dose Levels of Didanosine Used in Combination With Stavudine in HIV-Infected Patients

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002207

Run by

Bristol-Myers Squibb

Starts

2004-02-01

Expected to finish

2004-02-01

Last updated by the study team

2011-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Any antiretroviral therapy.
• Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry.
• 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.

Where it is running

• Clinsites / Sorra Research Ctr — Birmingham, Alabama, United States
• Shared Med Research Foundation — Tarzana, California, United States
• Indiana Univ School of Medicine / Dept of Infect Dis — Indianapolis, Indiana, United States
• Medicine Faculty Associates — Ypsilanti, Michigan, United States
• New Jersey Community Research Initiative — Newark, New Jersey, United States
• ID Care Inc — Somerville, New Jersey, United States
• Fanno Creek Clinic — Portland, Oregon, United States
• Anderson Clinical Research — Pittsburgh, Pennsylvania, United States
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Univ of Texas Med Branch — Galveston, Texas, United States
• Houston Clinical Research Network — Houston, Texas, United States
• Hampton Roads Med Specialists — Hampton, Virginia, United States
• Dr Iraj Mirshahi — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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