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

Further Study Details: 

Expected Total 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.

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

Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.
• Have a CD4 count of at least 250 cells/mm3.
• Have an HIV count (viral load) of at least 5,000 copies/ml.
• Are at least 18 years old.

Exclusion Criteria

You will not be eligible for this study if you:

• Have received prescription or nonprescription medications within 14 days of study entry, or if you will need to take any of these medications during the study.
• Have ever received anti-HIV medications.
• Test positive for hepatitis B.
• Have received a blood (or red blood cell) transfusion within 3 months prior to study entry.
• Have severe diarrhea.
• Have severe heart, liver, kidney, or neurological (brain and spinal cord) disease.
• Have hemophilia or another blood disorder.
• Have received certain medications or vaccines within 30 days prior to study entry.
• Have received chemotherapy or radiation within 16 days prior to study entry, or if you will need either of these during the study.

Florida
      South Florida Bioavailability Clinic, Miami,  Florida,  331813405,  United States
      Treasure Coast Infectious Disease Consultants, Vero Beach,  Florida,  32960,  United States
Illinois
      Cook County Hosp, Chicago,  Illinois,  60612,  United States
Maryland
      Univ of Maryland Institute of Human Virology, Baltimore,  Maryland,  212011192,  United States
Massachusetts
      Boston Med Ctr / Clinical Research Office, Boston,  Massachusetts,  02118,  United States
New York
      Beth Israel Med Ctr, New York,  New York,  10003,  United States
Pennsylvania
      Anderson Clinical Research / Inc, Pittsburgh,  Pennsylvania,  15213,  United States
Tennessee
      Vanderbilt Univ Med Ctr, Nashville,  Tennessee,  37212,  United States
Texas
      Univ of Texas / Med Branch at Galveston, Galveston,  Texas,  775550835,  United States

Study ID Numbers:  297A; 57CL-9802
Record last reviewed:  July 2000
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002243
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08