CClinicalTrials.gg
Sign In
CompletedNCT00002243Updated Jun 24, 2005

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 1 interventional study of Calanolide A in HIV Infections, sponsored by Sarawak MediChem Pharmaceuticals. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Sarawak MediChem Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Infections

Keywords

  • Anti-HIV Agents
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 32 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Sarawak MediChem Pharmaceuticals is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Masking
Double
Enrollment
32 participants

Interventions

  • DrugCalanolide A
06

Study locations

9 sites
  • South Florida Bioavailability Clinic
    Miami, Florida 331813405, United States
  • Treasure Coast Infectious Disease Consultants
    Vero Beach, Florida 32960, United States
  • Cook County Hosp
    Chicago, Illinois 60612, United States
  • Univ of Maryland Institute of Human Virology
    Baltimore, Maryland 212011192, United States
  • Boston Med Ctr / Clinical Research Office
    Boston, Massachusetts 02118, United States
  • Beth Israel Med Ctr
    New York, New York 10003, United States
  • Anderson Clinical Research / Inc
    Pittsburgh, Pennsylvania 15213, United States
  • Vanderbilt Univ Med Ctr
    Nashville, Tennessee 37212, United States
  • Univ of Texas / Med Branch at Galveston
    Galveston, Texas 775550835, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002243
Lead sponsor
Sarawak MediChem Pharmaceuticals
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2000. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

HIV Infections→

Other studies from this sponsor

Sarawak MediChem Pharmaceuticals

Start the discussion