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| Tracking Information | |||||
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| First Received Date ICMJE | November 2, 1999 | ||||
| Last Updated Date | August 15, 2007 | ||||
| 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 NCT00002371 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine | ||||
| Official Title ICMJE | A Randomized Double-Blind Study of Safety, Virologic and Immunological Effects of Stavudine Plus Lamivudine (3TC) Versus Zidovudine Plus Lamivudine in HIV-Infected Subjects Following At Least Six Months of Zidovudine Therapy | ||||
| Brief Summary | To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups. |
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| Detailed Description | Patients will be randomized to either Stavudine (d4T) + Lamivudine (3TC) + Zidovudine placebo or Zidovudine (ZDV) + Lamivudine + Stavudine placebo. Patients whose plasma HIV RNA levels remain >= 500 copies/ml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety 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 | 80 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria Patients must have:
Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication: Excluded:
Patients with any of the following prior conditions or symptoms are excluded:
Prior Medication: Excluded:
Risk Behavior: Excluded:
Required: At least 6 months of prior cumulative ZDV therapy. |
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| 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, Canada, Puerto Rico | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00002371 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 244B, AI455-048 | ||||
| Study Sponsor ICMJE | Bristol-Myers Squibb | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Bristol-Myers Squibb | ||||
| Verification Date | August 2007 | ||||
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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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