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| Sponsored by: |
Merck |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002241 |
Purpose
The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: Indinavir sulfate Drug: Ritonavir Drug: Lamivudine Drug: Stavudine |
Phase II |
| MedlinePlus related topics: | AIDS AIDS Medicines |
| Drug Information available for: | Lamivudine Indinavir Indinavir Sulfate Stavudine Ritonavir |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Efficacy of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 100 Mg/d4T/3TC b.i.d. in HIV-Infected Individuals |
| Estimated Enrollment: | 80 |
Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks. Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. At Week 24, the proportion of patients with plasma viral RNA below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. An observed response proportion of 80% or higher will be considered clinically meaningful.
Eligibility
| Ages Eligible for Study: | 16 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, Alabama | |||||
| Univ of Alabama at Birmingham | |||||
| Birmingham, Alabama, United States, 35294 | |||||
| United States, California | |||||
| Univ of California at San Francisco Gen Hosp | |||||
| San Francisco, California, United States, 94110 | |||||
| Kaiser Foundation Hospital | |||||
| San Francisco, California, United States, 94118 | |||||
| HIV Institute / Davies Med Ctr | |||||
| San Francisco, California, United States, 94114 | |||||
| Apogee Med Group | |||||
| San Diego, California, United States, 92101 | |||||
| United States, Florida | |||||
| Univ of Miami School of Medicine | |||||
| Miami, Florida, United States, 33136 | |||||
| United States, Illinois | |||||
| AIDS Research Alliance - Chicago | |||||
| Chicago, Illinois, United States, 60657 | |||||
| United States, Louisiana | |||||
| Tulane Univ School of Medicine | |||||
| New Orleans, Louisiana, United States, 70112 | |||||
| United States, Massachusetts | |||||
| CRI New England | |||||
| Brookline, Massachusetts, United States, 02146 | |||||
| United States, New York | |||||
| Mount Sinai Med Ctr | |||||
| New York, New York, United States, 10029 | |||||
| Montefiore Med Ctr | |||||
| Bronx, New York, United States, 10467 | |||||
| Bronx Lebanon Hosp Ctr | |||||
| Bronx, New York, United States, 10456 | |||||
| Chelsea Village Med Ctr | |||||
| New York, New York, United States, 10014 | |||||
| Liberty Med Group | |||||
| New York, New York, United States, 10016 | |||||
| St Lukes / Roosevelt Hosp / HIV Center | |||||
| New York, New York, United States, 10019 | |||||
| SUNY Health Sciences Ctr | |||||
| Brooklyn, New York, United States, 11203 | |||||
| United States, Pennsylvania | |||||
| Mark Watkins | |||||
| Philadelphia, Pennsylvania, United States, 19107 | |||||
| United States, Texas | |||||
| Univ of Texas / Thomas Street Clinic | |||||
| Houston, Texas, United States, 77030 | |||||
| Merck |
More Information
| Study ID Numbers: | 246T, 094-00, CRX463 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002241 |
| Health Authority: | United States: Food and Drug Administration |
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