A Study to Evaluate the Safety and Effectiveness of a New Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), (+)-Calanolide A, in HIV-Positive Patients Who Have Never Received Anti-HIV Treatment - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study to Evaluate the Safety and Effectiveness of a New Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), (+)-Calanolide A, in HIV-Positive Patients Who Have Never Received Anti-HIV Treatment
Official Title ^ICMJE	A Phase 1B Dose-Range 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 test the safety and effectiveness of a new non-nucleoside reverse transcriptase inhibitor (NNRTI), (+)-calanolide A, in HIV-positive patients who have never received anti-HIV treatment.
Detailed Description	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.
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	Completed
Enrollment ^ICMJE	32
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have a CD4 count of at least 250 cells/mm3. Have an HIV count (viral load) of at least 5,000 copies/ml. Are at least 18 years old. Exclusion Criteria You will not be eligible for this study if you: Have received prescription or nonprescription medications within 14 days of study entry, or if you will need to take any of these medications during the study. Have ever received anti-HIV medications. Test positive for hepatitis B. Have received a blood (or red blood cell) transfusion within 3 months prior to study entry. Have severe diarrhea. Have severe heart, liver, kidney, or neurological (brain and spinal cord) disease. Have hemophilia or another blood disorder. Have received certain medications or vaccines within 30 days prior to study entry. Have received chemotherapy or radiation within 16 days prior to study entry, or if you will need either of these during the study.
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	NCT00002243
Responsible Party
Study ID Numbers ^ICMJE	297A, 57CL-9802
Study Sponsor ^ICMJE	Sarawak MediChem Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	July 2000
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP