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

HIV Infections Clinical Trial

Official title:

A Phase 1B Dose-Range 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: Completed

Administrative data

• NCT number: NCT00002243
• Other study ID #: 297A
• Secondary ID: 57CL-9802
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: July 2000
• 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 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.

Description:

Patients are randomized into 2 cohorts, with Cohort 2 receiving a higher dosage than Cohort 1. Patients in each cohort receive either (+)-calanolide A or a placebo for 14 days, followed by a 14-day follow-up period. Following study treatment, patients may elect to receive an open-label, 6-month course of anti-HIV drugs to be selected by and administered under the care of the patient's physician.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

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

Sponsors (1)

Lead Sponsor	Collaborator
Sarawak MediChem Pharmaceuticals

Country where clinical trial is conducted

United States,