HIV Infections
Conditions
Keywords
CD4 Lymphocyte Count, Biological Markers, Anti-HIV Agents, Viral Load, Pharmacokinetics, calanolide A
Brief summary
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
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.
Interventions
DRUGCalanolide A
Sponsors
Sarawak MediChem Pharmaceuticals
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed