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Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002429
First received: November 2, 1999
Last updated: April 28, 2011
Last verified: April 2011
History of Changes
  Purpose

This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach before dissolving. The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination.


Condition Intervention Phase
HIV Infections
 Drug: Lamivudine/Zidovudine
Drug: Nelfinavir mesylate
Drug: Stavudine
Drug: Didanosine
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Evaluation of HIV RNA Suppression Produced by a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine (ddI EC) Administered Once Daily Compared to a Reference Combination Regimen

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment: 500
Study Start Date: July 1999
Study Completion Date: January 2001
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
Detailed Description:

Patients are randomized to 1 of 2 groups for 48 weeks of open-label treatment. Group 1 receives ddI EC plus d4T plus NFV. Group 2 receives Combivir plus NFV. Antiviral activity is determined by the proportion of patients with HIV RNA levels of less than 400 copies/ml at Week 48.

  Eligibility

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

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have a viral load of at least 2,000 copies/ml and a CD4 count of at least 200 cells/mm3.
  • Are at least 18 years old.
  • Agree to practice sexual abstinence or to use effective barrier methods of birth control (such as condoms).

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have had severe diarrhea within 30 days of study entry.
  • Have a history of pancreatic disease or any other serious condition.
  • Have hepatitis within 30 days of study entry.
  • Are diagnosed with an opportunistic (AIDS-related) infection at the time of enrollment.
  • Are unable to take medications by mouth.
  • Have received certain medications.
  • Are pregnant or breast-feeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002429

  Show 23 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Publications:
Gathe J, Badero R, Grimwood A, Abrams L, Klesczewski K, Mclaren C. AI454152: Comparison of a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine Administered Once-Daily Versus a Regimen of Combivir Plus Nelfinavir. 8th Conference on Retroviruses and Opportunistic Infections, 2001 Feb 4-8. (abstract no 319)

ClinicalTrials.gov Identifier: NCT00002429     History of Changes
Other Study ID Numbers: 039F, AI454-152
Study First Received: November 2, 1999
Last Updated: April 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Didanosine
Drug Therapy, Combination
Stavudine
RNA, Viral
 Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents

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
Didanosine
Zidovudine
Stavudine
Lamivudine
 Reverse Transcriptase Inhibitors
Lamivudine, zidovudine drug combination
Nelfinavir
Anti-HIV Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013