Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen
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ClinicalTrials.gov Identifier: NCT00002429 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: May 4, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Lamivudine/Zidovudine Drug: Nelfinavir mesylate Drug: Stavudine Drug: Didanosine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 500 participants |
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 |
Study Start Date : | July 1999 |
Actual Primary Completion Date : | January 2001 |
Actual Study Completion Date : | January 2001 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002429

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Publications:
ClinicalTrials.gov Identifier: | NCT00002429 History of Changes |
Other Study ID Numbers: |
039F AI454-152 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | May 4, 2011 |
Last Verified: | April 2011 |
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine Zidovudine Stavudine Didanosine |
Lamivudine, zidovudine drug combination Nelfinavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Antimetabolites HIV Protease Inhibitors Protease Inhibitors |