NCT00002243

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 2000

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Anti-HIV Agents

Interventions

Calanolide ADRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

South Florida Bioavailability Clinic

Miami, Florida, 331813405, United States

Location

Treasure Coast Infectious Disease Consultants

Vero Beach, Florida, 32960, United States

Location

Cook County Hosp

Chicago, Illinois, 60612, United States

Location

Univ of Maryland Institute of Human Virology

Baltimore, Maryland, 212011192, United States

Location

Boston Med Ctr / Clinical Research Office

Boston, Massachusetts, 02118, United States

Location

Beth Israel Med Ctr

New York, New York, 10003, United States

Location

Anderson Clinical Research / Inc

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt Univ Med Ctr

Nashville, Tennessee, 37212, United States

Location

Univ of Texas / Med Branch at Galveston

Galveston, Texas, 775550835, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

calanolide A

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 2000-07

Locations

US(9)