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

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

Sponsors

Lead sponsor: Bristol-Myers Squibb

Source Bristol-Myers Squibb
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.

Detailed Description

Patients are randomized to receive ddI given either qd or bid in combination with d4T given bid (no doses specified).

Overall Status Completed
Start Date February 2004
Completion Date February 2004
Primary Completion Date February 2004
Phase N/A
Study Type Interventional
Condition
Intervention

Intervention type: Drug

Intervention name: Stavudine

Intervention type: Drug

Intervention name: Didanosine

Eligibility

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
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
Location Countries

United States

Verification Date

April 2011

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov