The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
This trial is active, not recruiting.
|Sponsor||Sarawak MediChem Pharmaceuticals|
|Start date||April 2000|
|Trial size||16 participants|
|Trial identifier||NCT00005120, 297B, 57CL-0001|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Miami, FL||South Florida Bioavailability Clinic||no longer recruiting|
|Chicago, IL||Chicago Ctr for Clinical Research||no longer recruiting|
|Chicago, IL||The CORE Ctr||no longer recruiting|
|Philadelphia, PA||Anderson Clinical Research||no longer recruiting|
|Pittsburgh, PA||Anderson Clinical Research||no longer recruiting|
|Columbia, SC||Burnside Clinic||no longer recruiting|
|Galveston, TX||Univ of Texas Med Branch||no longer recruiting|
|Endpoint classification||pharmacokinetics study|
Male or female participants at least 18 years old.
Inclusion Criteria Patients may be eligible for this study if they: - Are at least 18 years old. - Agree to use effective methods of birth control during the study. - Have a CD4 cell count of 200 cells/mm3 or more. - Have HIV levels of 5000 copies/ml or more. Exclusion Criteria Patients will not be eligible for this study if they: - Have abnormal blood tests. - Have had a reaction to study medication. - Have a history of opportunistic (AIDS-related) infection or cancer. - Are being treated for active pulmonary tuberculosis. - Have a fever of 39 degrees C or more within 14 days of beginning study treatment. - Are unable to take medications by mouth. - Have an abnormal chest X-ray or ECG within 30 days of beginning study treatment. - Have hepatitis, hemophilia, or other blood disorder. - Have significant heart, stomach, intestinal, liver, nerve, or kidney problems. - Have a condition which may affect ability to participate in this study, such as drug or alcohol abuse or a serious mental disorder. - Have taken anti-HIV drugs in the past. - Are taking certain medications. - Have had a blood transfusion within the 3 months prior to entering the study. - Have had radiation or chemotherapy within 16 days before the screening visit or plan to receive such treatment during the study. - Are pregnant or breast-feeding.
|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|
|Description||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.|
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