Clinical trial NCT00002243: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: South Florida Bioavailability Clinic
state: Florida
city: Vero Beach
country: United States
facility: Treasure Coast Infectious Disease Consultants
state: Florida
city: Chicago
country: United States
facility: Cook County Hosp
state: Illinois
city: Baltimore
country: United States
facility: Univ of Maryland Institute of Human Virology
state: Maryland
city: Boston
country: United States
facility: Boston Med Ctr / Clinical Research Office
state: Massachusetts
city: New York
country: United States
facility: Beth Israel Med Ctr
state: New York
city: Pittsburgh
country: United States
facility: Anderson Clinical Research / Inc
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Univ Med Ctr
state: Tennessee
city: Galveston
country: United States
facility: Univ of Texas / Med Branch at Galveston
state: Texas
Study officials:
References: