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

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

October 1, 2007

Start Date ^ICMJE

February 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002207 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacokinetics Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Stavudine
Drug: Didanosine

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00002207

Responsible Party

Study ID Numbers ^ICMJE

039D, AI454-143

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

. .

Information Provided By

Bristol-Myers Squibb

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP