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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002207
• Other study ID #: 039D
• Secondary ID: AI454-143
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: April 13, 2011
• Start date: February 2004
• Est. completion date: February 2004

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Stavudine

• Didanosine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm