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| Sponsored by: |
Sarawak MediChem Pharmaceuticals |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00005120 |
Purpose
The purpose of this study is to see if it is safe and effective to give calanolide A to HIV-infected adults who have not used anti-HIV drugs in the past.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: Calanolide A |
Phase I |
| MedlinePlus related topics: | AIDS AIDS Medicines |
| Drug Information available for: | Calanolide A |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Pharmacokinetics Study |
| Official Title: | A Phase IB 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: | 16 |
| Study Start Date: | April 2000 |
Patients are randomized to receive (+)-calanolide A or placebo for 21 days. All patients may elect to receive an open-label, 3-month course of approved retroviral therapy (up to triple-drug therapy) to be selected by, and administered under the care of, the patients' physicians. If the patient has no insurance coverage or does not wish to utilize his/her insurance for anti-HIV medications, Sarawak MediChem Pharmaceuticals will provide these medications at no charge for up to 3 months.
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, Florida | |||||
| South Florida Bioavailability Clinic | |||||
| Miami, Florida, United States, 331813405 | |||||
| United States, Illinois | |||||
| Chicago Ctr for Clinical Research | |||||
| Chicago, Illinois, United States, 60610 | |||||
| The CORE Ctr | |||||
| Chicago, Illinois, United States, 60612 | |||||
| United States, Pennsylvania | |||||
| Anderson Clinical Research | |||||
| Philadelphia, Pennsylvania, United States, 19107 | |||||
| Anderson Clinical Research | |||||
| Pittsburgh, Pennsylvania, United States, 15221 | |||||
| United States, South Carolina | |||||
| Burnside Clinic | |||||
| Columbia, South Carolina, United States, 29206 | |||||
| United States, Texas | |||||
| Univ of Texas Med Branch | |||||
| Galveston, Texas, United States, 775550835 | |||||
| Sarawak MediChem Pharmaceuticals |
More Information
| Study ID Numbers: | 297B, 57CL-0001 |
| First Received: | April 20, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00005120 |
| Health Authority: | United States: Food and Drug Administration |
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