Completed

Safety and Effects of (+)-Calanolide A in HIV-Positive Patients Without Prior Antiretroviral Therapy

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What is being tested

Calanolide A

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorSarawak MediChem Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002243
Principal SponsorSarawak MediChem Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

4 inclusion criteria required to participate
Are HIV-positive
Are at least 18 years old
Have a CD4 count of at least 250 cells/mm3
Have an HIV count (viral load) of at least 5,000 copies/ml
9 exclusion criteria prevent from participating
Have ever received anti-HIV medications
Have hemophilia or another blood disorder
Have received a blood (or red blood cell) transfusion within 3 months prior to study entry
Have received certain medications or vaccines within 30 days prior to study entry
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

South Florida Bioavailability Clinic

Miami, United StatesOpen South Florida Bioavailability Clinic in Google Maps

Treasure Coast Infectious Disease Consultants

Vero Beach, United States

Cook County Hosp

Chicago, United States

Univ of Maryland Institute of Human Virology

Baltimore, United States
Completed9 Study Centers