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| Sponsor: | PPD |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00006397 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Ritonavir Drug: Stavudine Drug: Didanosine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Pharmacokinetics Study |
| Official Title: | 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 |
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations| United States, California | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| Univ of Southern California | |
| Los Angeles, California, United States, 90033 | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| United States, Florida | |
| Saint Josephs Comprehensive Research Institute | |
| Tampa, Florida, United States, 33607 | |
| North Broward Hosp District / HIV Clinical Research | |
| Fort Lauderdale, Florida, United States, 33311 | |
| United States, Louisiana | |
| Louisiana State Univ Med Ctr / HIV Outpatient Clinic | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| JSI Research and Training Institute | |
| Boston, Massachusetts, United States, 02210 | |
| United States, New Jersey | |
| Univ of Med & Dentistry of New Jersey | |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 14642 | |
| Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| United States, Tennessee | |
| Vanderbilt Univ School of Medicine | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| Univ of Texas Southwestern Med Ctr | |
| Dallas, Texas, United States, 75390 | |
| Puerto Rico | |
| Ponce Univ Hosp | |
| Ponce, Puerto Rico, 00731 | |
| Univ of Puerto Rico School of Med | |
| Rio Piedras, Puerto Rico, 00935 | |
More Information
| Study ID Numbers: | 312A, BMS 2000 |
| Study First Received: | October 10, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00006397 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Didanosine Drug Therapy, Combination Stavudine HIV Protease Inhibitors Sex Factors |
Ritonavir Indinavir Dosage Forms Reverse Transcriptase Inhibitors Anti-HIV Agents |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Indinavir Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors RNA Virus Infections |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Didanosine HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |