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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00002202 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A Comparison of 141W94 and Indinavir in HIV-Infected Patients |
| Official Title ICMJE | A Phase III Trial to Compare the Safety and Antiviral Efficacy of 141W94 With Indinavir in Combination With Nucleoside Reverse Transcriptase Inhibitor (NRTI) Therapy, in NRTI-Experienced, Protease Inhibitor (PI)-Naive, HIV-1-Infected Patients. |
| Brief Summary | The purpose of this study is to see if 141W94 is as safe and effective as indinavir when used with nucleoside reverse transcriptase inhibitors (NRTIs) for 48 weeks. This study also examines what effect other drugs have on how the body handles 141W94. |
| Detailed Description | |
| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Pharmacokinetics Study |
| Condition ICMJE | HIV Infections |
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 460 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded:
Concurrent Medication: Excluded:
Concurrent Treatment: Excluded: Radiation therapy (except local treatment for Kaposi's sarcoma). Patients with the following prior conditions are excluded: Clinically relevant pancreatitis or hepatitis within the last 6 months. Prior Medication: Excluded:
Prior Treatment: Excluded: Radiation therapy within 30 days prior to study drug administration (except local treatment for Kaposi's sarcoma). Risk Behavior: Excluded: Current alcohol or illicit drug use that may interfere with drug absorption or ability to take oral medication. Required: NRTI therapy at day of entry and up to screening. Required: >= 12 weeks of NRTI therapy. |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00002202 |
| Responsible Party | |
| Study ID Numbers ICMJE | 264E, PROA/B3006 |
| Study Sponsor ICMJE | Glaxo Wellcome |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | November 1998 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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