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

S

Sarawak MediChem Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

HIV Infections

Treatments

Drug: Calanolide A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002243
57CL-9802
297A

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems