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	Treatment or Intervention	Phase
HIV Infections	Drug: Calanolide A	Phase I

Further Study Details: 

Expected Total Enrollment:  16

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Florida
      South Florida Bioavailability Clinic, Miami,  Florida,  331813405,  United States
Illinois
      Chicago Ctr for Clinical Research, Chicago,  Illinois,  60610,  United States
      The CORE Ctr, Chicago,  Illinois,  60612,  United States
Pennsylvania
      Anderson Clinical Research, Philadelphia,  Pennsylvania,  19107,  United States
      Anderson Clinical Research, Pittsburgh,  Pennsylvania,  15221,  United States
South Carolina
      Burnside Clinic, Columbia,  South Carolina,  29206,  United States
Texas
      Univ of Texas Med Branch, Galveston,  Texas,  775550835,  United States

Study ID Numbers:  297B; 57CL-0001
Record last reviewed:  June 2001
Last Updated:  October 13, 2004
Record first received:  April 20, 2000
ClinicalTrials.gov Identifier:  NCT00005120
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08