The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Study Overview
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Brief Summary
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The purpose of this study is to see if it is safe and effective to give calanolide A to HIV-infected adults who have not used anti-HIV drugs in the past.

Detailed Description
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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.

Official Title
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A Phase IB Study to Evaluate the Safety, Pharmacokinetics, and Effects of (+)-Calanolide A on Surrogate Markers in HIV-Positive Patients With No Previous Antiretroviral Therapy

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Calanolide A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients may be eligible for this study if they: Are at least 18 years old. Agree to use effective methods of birth control during the study. Have a CD4 cell count of 200 cells/mm3 or more. Have HIV levels of 5000 copies/ml or more. Exclusion Criteria Patients will not be eligible for this study if they: Have abnormal blood tests. Have had a reaction to study medication. Have a history of opportunistic (AIDS-related) infection or cancer. Are being treated for active pulmonary tuberculosis. Have a fever of 39 degrees C or more within 14 days of beginning study treatment. Are unable to take medications by mouth. Have an abnormal chest X-ray or ECG within 30 days of beginning study treatment. Have hepatitis, hemophilia, or other blood disorder. Have significant heart, stomach, intestinal, liver, nerve, or kidney problems. Have a condition which may affect ability to participate in this study, such as drug or alcohol abuse or a serious mental disorder. Have taken anti-HIV drugs in the past. Are taking certain medications. Have had a blood transfusion within the 3 months prior to entering the study. Have had radiation or chemotherapy within 16 days before the screening visit or plan to receive such treatment during the study. Are pregnant or breast-feeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Calanolide A|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CD4 Lymphocyte Count, Biological Markers, Anti-HIV Agents, Viral Load, Pharmacokinetics, calanolide A