The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Status unconfirmed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00005120

Run by

Sarawak MediChem Pharmaceuticals

People needed

16

Starts

2000-04-01

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…

• 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.

You may not qualify if…

• 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.

Where it is running

• South Florida Bioavailability Clinic — Miami, Florida, United States
• Chicago Ctr for Clinical Research — Chicago, Illinois, United States
• The CORE Ctr — Chicago, Illinois, United States
• Anderson Clinical Research — Philadelphia, Pennsylvania, United States
• Anderson Clinical Research — Pittsburgh, Pennsylvania, United States
• Burnside Clinic — Columbia, South Carolina, United States
• Univ of Texas Med Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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