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| Sponsored by: |
Sarawak MediChem Pharmaceuticals |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002243 |
Purpose
The purpose of this study is to test the safety and effectiveness of a new non-nucleoside reverse transcriptase inhibitor (NNRTI), (+)-calanolide A, in HIV-positive patients who have never received anti-HIV treatment.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: Calanolide A |
Phase I |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | Calanolide A |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Pharmacokinetics Study |
| Official Title: | A Phase 1B Dose-Range Study to Evaluate the Safety, Pharmacokinetics, and Effects of (+)-Calanolide A on Surrogate Markers in HIV-Positive Patients With No Previous Antiretroviral Therapy |
| Estimated Enrollment: | 32 |
Patients are randomized into 2 cohorts, with Cohort 2 receiving a higher dosage than Cohort 1. Patients in each cohort receive either (+)-calanolide A or a placebo for 14 days, followed by a 14-day follow-up period. Following study treatment, patients may elect to receive an open-label, 6-month course of anti-HIV drugs to be selected by and administered under the care of the patient's physician.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
Contacts and Locations| United States, Florida | |||||
| South Florida Bioavailability Clinic | |||||
| Miami, Florida, United States, 331813405 | |||||
| Treasure Coast Infectious Disease Consultants | |||||
| Vero Beach, Florida, United States, 32960 | |||||
| United States, Illinois | |||||
| Cook County Hosp | |||||
| Chicago, Illinois, United States, 60612 | |||||
| United States, Maryland | |||||
| Univ of Maryland Institute of Human Virology | |||||
| Baltimore, Maryland, United States, 212011192 | |||||
| United States, Massachusetts | |||||
| Boston Med Ctr / Clinical Research Office | |||||
| Boston, Massachusetts, United States, 02118 | |||||
| United States, New York | |||||
| Beth Israel Med Ctr | |||||
| New York, New York, United States, 10003 | |||||
| United States, Pennsylvania | |||||
| Anderson Clinical Research / Inc | |||||
| Pittsburgh, Pennsylvania, United States, 15213 | |||||
| United States, Tennessee | |||||
| Vanderbilt Univ Med Ctr | |||||
| Nashville, Tennessee, United States, 37212 | |||||
| United States, Texas | |||||
| Univ of Texas / Med Branch at Galveston | |||||
| Galveston, Texas, United States, 775550835 | |||||
| Sarawak MediChem Pharmaceuticals |
More Information
| Study ID Numbers: | 297A, 57CL-9802 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002243 |
| Health Authority: | United States: Food and Drug Administration |
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