Clinical trial NCT00005120: The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: HIV Infections
Keywords: CD4 Lymphocyte Count
Biological Markers
Anti-HIV Agents
Viral Load
Pharmacokinetics
calanolide A
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 16
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 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: South Florida Bioavailability Clinic
state: Florida
city: Chicago
country: United States
facility: Chicago Ctr for Clinical Research
state: Illinois
city: Chicago
country: United States
facility: The CORE Ctr
state: Illinois
city: Philadelphia
country: United States
facility: Anderson Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Anderson Clinical Research
state: Pennsylvania
city: Columbia
country: United States
facility: Burnside Clinic
state: South Carolina
city: Galveston
country: United States
facility: Univ of Texas Med Branch
state: Texas
Study officials:
References: