Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily |
| Estimated Enrollment: | 120 |
| Study Start Date: | March 1999 |
| Study Completion Date: | March 1999 |
| Primary Completion Date: | March 1999 (Final data collection date for primary outcome measure) |
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 |
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
Show 24 Study Locations| Principal Investigator: | . . | . |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002224 History of Changes |
| Other Study ID Numbers: | 039G, AI454-158 |
| Study First Received: | November 2, 1999 |
| Last Updated: | April 13, 2011 |
| 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 |
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 Stavudine Reverse Transcriptase Inhibitors |
Nelfinavir HIV Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013