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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002243

Enrollment

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Anti-HIV Agents

Brief 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.

Detailed 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.

Interventions

DRUGCalanolide A

Study design

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026