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

HIV Infections Clinical Trial

Official title:

A Phase IB Study to Evaluate the Safety, Pharmacokinetics, and Effects of (+)-Calanolide A on Surrogate Markers in HIV-Positive Patients With No Previous Antiretroviral Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00005120
• Other study ID #: 297B
• Secondary ID: 57CL-0001
• Status: Active, not recruiting
• Phase: Phase 1
• First received: April 20, 2000
• Last updated: June 23, 2005
• Start date: April 2000

Study information

• Verified date: June 2001
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Calanolide A

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sarawak MediChem Pharmaceuticals

Country where clinical trial is conducted

United States,