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

NCT ID: NCT00005120

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-04-30

Brief Summary

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.

Detailed Description

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.

Conditions

HIV Infections

Keywords

CD4 Lymphocyte Count; Biological Markers; Anti-HIV Agents; Viral Load; Pharmacokinetics; calanolide A

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Calanolide A

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sarawak MediChem Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Locations

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

Countries

United States

Other Identifiers

57CL-0001

Identifier Type: -

Identifier Source: secondary_id

297B

Identifier Type: -

Identifier Source: org_study_id