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

Tracking Information
First Received Date ^ICMJE	April 20, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	April 2000
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00005120 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Official Title ^ICMJE	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
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.
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Pharmacokinetics Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Calanolide A
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	16
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00005120
Responsible Party
Study ID Numbers ^ICMJE	297B, 57CL-0001
Study Sponsor ^ICMJE	Sarawak MediChem Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	June 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP