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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Didanosine Nelfinavir Nelfinavir Mesylate Stavudine

U.S. FDA Resources

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

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

No publications provided

Study ID Numbers:	039G, AI454-158
Study First Received:	November 2, 1999
Last Updated:	August 15, 2007
ClinicalTrials.gov Identifier:	NCT00002224 History of Changes
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:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Stavudine
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes

Protease Inhibitors
Reverse Transcriptase Inhibitors
Virus Diseases
Didanosine
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Nelfinavir
Retroviridae Infections

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Stavudine
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Nelfinavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors

RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
Didanosine
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on September 02, 2009