Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI) - Full Text View

Purpose

Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. The purpose of this study is to compare the effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).

Condition	Intervention	Phase
HIV Infections	Drug: Nelfinavir mesylate Drug: Stavudine Drug: Didanosine	Phase III

MedlinePlus related topics:

AIDS AIDS Medicines

Drug Information available for:

Didanosine Stavudine Nelfinavir Nelfinavir Mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily

Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment:	120
Study Start Date:	March 1999
Estimated Study Completion Date:	March 1999

Detailed Description:

Patients are randomized to 1 of 2 open-label treatment groups. Group 1 receives ddI EC plus d4T plus NLF for 48 weeks. Group 2 receives ddI plus d4T plus NLF for 48 weeks. Both forms of ddI are administered orally once daily. Antiviral activity is determined by the magnitude and the duration of reduction of plasma HIV RNA from baseline through Week 24.

Eligibility

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

Criteria

Inclusion Criteria

You may be eligible for this study if you:

Are HIV-positive.
Are at least 18 years old.
Have a viral load of at least 5,000 copies/ml and a CD4 count of at least 100 cells/mm3.

Exclusion Criteria

You will not be eligible for this study if you:

Have received more than 4 weeks of treatment with nucleoside anti-HIV medications (NRTIs), or more than 1 week with protease inhibitors. (All anti-HIV treatments other than study medications must be stopped at least 14 days prior to study entry.)
Have severe diarrhea.
Are pregnant or breast-feeding.
Have a history of pancreatic disease or any other serious condition.
Have hepatitis within 30 days prior to study entry.
Cannot take medications by mouth.
Have received certain medications.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002224

Show 24 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Principal Investigator:	. .	.

More 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

Study ID Numbers:	039G, AI454-158
First Received:	November 2, 1999
Last Updated:	August 15, 2007
ClinicalTrials.gov Identifier:	NCT00002224
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Didanosine

Drug Therapy, Combination

Drug Administration Schedule

Stavudine

HIV Protease Inhibitors

Nelfinavir

Reverse Transcriptase Inhibitors

Anti-HIV Agents

Viral Load

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Stavudine

Didanosine

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Nelfinavir

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

HIV Protease Inhibitors

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Protease Inhibitors

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00002224