The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
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ClinicalTrials.gov Identifier: NCT00005120
Recruitment Status : Unknown
Verified June 2001 by NIH AIDS Clinical Trials Information Service. Recruitment status was: Active, not recruiting
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 or disease
Drug: Calanolide A
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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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.