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

Sponsor

Sarawak MediChem Pharmaceuticals (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00005120

Collaborator

(none)

Enrollment

Locations

2.3

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Calanolide A	Phase 1

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.

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Florida Bioavailability Clinic	Miami	Florida	United States	331813405
2	Chicago Ctr for Clinical Research	Chicago	Illinois	United States	60610
3	The CORE Ctr	Chicago	Illinois	United States	60612
4	Anderson Clinical Research	Philadelphia	Pennsylvania	United States	19107
5	Anderson Clinical Research	Pittsburgh	Pennsylvania	United States	15221
6	Burnside Clinic	Columbia	South Carolina	United States	29206
7	Univ of Texas Med Branch	Galveston	Texas	United States	775550835