A Study to Evaluate 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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002243

Run by

Sarawak MediChem Pharmaceuticals

People needed

32

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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