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| Tracking Information | |
|---|---|
| First Received Date ICMJE | October 10, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | August 2000 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00006397 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs |
| Official Title ICMJE | A Study of the Combination of Indinavir, Ritonavir, Enteric-Coated ddI and d4T In Nucleoside and Non-Nucleoside Reverse Transcriptase Inhibitor Experienced Patients: An Open-Label Study Investigating Differences Between Women and Men |
| Brief Summary | The purpose of this study is to see how safe and effective it is to give multi-drug treatment with indinavir (IDV) plus ritonavir (RTV) plus enteric-coated didanosine (ddI) plus stavudine (d4T) and if there are differences in responses between men and women. |
| Detailed Description | Patients are enrolled in balanced numbers based on gender and stratified by viral load (less than or equal to 10,000, 10,000 to 100,000, or more than 100,000 copies/ml). Prior to therapy, a peer-based patient education intervention is presented. Patients receive a combination of IDV, RTV, enteric-coated ddI, and d4T. Responses to this multi-agent antiretroviral drug regimen are explored based on sex differences. A pharmacokinetic sub-study, balanced so that half of patients are male and half are female, is performed on IDV and RTV for 20 to 25 of the patients. About 20 females are examined for study-drug effects on gonadotropic hormone levels. |
| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Open Label, 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 | Active, not recruiting |
| Enrollment ICMJE | 200 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria Patients may be eligible for this study if they:
Exclusion Criteria Patients will not be eligible for this study if they:
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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, Puerto Rico |
| Administrative Information | |
| NCT ID ICMJE | NCT00006397 |
| Responsible Party | |
| Study ID Numbers ICMJE | 312A, BMS 2000 |
| Study Sponsor ICMJE | PPD |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | June 2001 |
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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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