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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002207
First received: November 2, 1999
Last updated: April 13, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Stavudine
Drug: Didanosine

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Study Start Date: February 2004
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002207

Locations
United States, Alabama
Clinsites / Sorra Research Ctr
Birmingham, Alabama, United States, 35203
United States, California
Shared Med Research Foundation
Tarzana, California, United States, 91356
United States, Indiana
Indiana Univ School of Medicine / Dept of Infect Dis
Indianapolis, Indiana, United States, 46202
United States, Michigan
Medicine Faculty Associates
Ypsilanti, Michigan, United States, 48197
United States, New Jersey
New Jersey Community Research Initiative
Newark, New Jersey, United States, 07103
ID Care Inc
Somerville, New Jersey, United States, 08876
United States, Oregon
Fanno Creek Clinic
Portland, Oregon, United States, 97219
United States, Pennsylvania
Anderson Clinical Research
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75235
Univ of Texas Med Branch
Galveston, Texas, United States, 775550835
Houston Clinical Research Network
Houston, Texas, United States, 77006
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Dr Iraj Mirshahi
Richmond, Virginia, United States, 23220
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Principal Investigator: . . .
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00002207     History of Changes
Other Study ID Numbers: 039D, AI454-143
Study First Received: November 2, 1999
Last Updated: April 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Didanosine
Drug Therapy, Combination
Stavudine
Reverse Transcriptase Inhibitors

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Stavudine
Didanosine
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antimetabolites
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 16, 2014