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The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs Clinical research trials and The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs. The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs clinical trial. Test subjects typically receive the most effective healthcare possible for their The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.

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



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

For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Sarawak MediChem Pharmaceuticals ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Double-Blind, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 16

Location and Contact Information:

Anderson Clinical Research
Philadelphia,  Pennsylvania,  19107
United States
 

Burnside Clinic
Columbia,  South Carolina,  29206
United States
 

Chicago Ctr for Clinical Research
Chicago,  Illinois,  60610
United States
 

The CORE Ctr
Chicago,  Illinois,  60612
United States
 

Anderson Clinical Research
Pittsburgh,  Pennsylvania,  15221
United States
 

Univ of Texas Med Branch
Galveston,  Texas,  775550835
United States
 

South Florida Bioavailability Clinic
Miami,  Florida,  331813405
United States
 


Additional Information:
Study ID Numbers:
  297B;  57CL-0001
Study Start Date: April 2000
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005120

Other Hiv Infections Studies:
1. Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children

2. A Study of Disease Progression and Anti-HIV Treatments

3. Prediction and Testing of Antigenic Sites of the AIDS Virus, HTLV-III Recognized by T Lymphocytes for the Development of Synthetic Vaccines

4. A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone

5. Anti-HIV Drugs During Pregnancy

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

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