Suspended

Safety and Pharmacokinetics 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
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2000
See protocol details

Summary

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

Study start date: April 1, 2000

Actual date on which the first participant was enrolled.

Patients are randomized to receive (+)-calanolide A or placebo for 21 days. All patients may elect to receive an open-label, 3-month course of approved retroviral therapy (up to triple-drug therapy) to be selected by, and administered under the care of, the patients' physicians. If the patient has no insurance coverage or does not wish to utilize his/her insurance for anti-HIV medications, Sarawak MediChem Pharmaceuticals will provide these medications at no charge for up to 3 months.

NCT00005120
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

16 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
Agree to use effective methods of birth control during the study
Are at least 18 years old
Have HIV levels of 5000 copies/ml or more
Have a CD4 cell count of 200 cells/mm3 or more
15 exclusion criteria prevent from participating
Are being treated for active pulmonary tuberculosis
Are pregnant or breast-feeding
Are taking certain medications
Are unable to take medications by mouth
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 7 locations

South Florida Bioavailability Clinic

Miami, United StatesOpen South Florida Bioavailability Clinic in Google Maps

Chicago Ctr for Clinical Research

Chicago, United States

The CORE Ctr

Chicago, United States

Anderson Clinical Research

Philadelphia, United States
Suspended7 Study Centers