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

November 2, 1999
April 13, 2011
February 2004
February 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002207 on ClinicalTrials.gov Archive Site
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A Comparison of Two Dose Levels of Didanosine Used in Combination With Stavudine in HIV-Infected Patients
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

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
  • Drug: Stavudine
  • Drug: Didanosine
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
February 2004
February 2004   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002207
039D, AI454-143
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Bristol-Myers Squibb
Not Provided
Principal Investigator: . . .
Bristol-Myers Squibb
April 2011

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