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A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects Clinical research trials and A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects. A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects clinical trial. Subjects often receive the most expert healthcare possible for their A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects  A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects
A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects
For Condition: HIV Infections
Status: Completed
Sponsor(s): VIMRx Pharmaceuticals , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: To determine the safety and tolerance of daily oral hypericin when given to achieve target trough levels within defined cohorts. To determine the responses of surrogate markers of HIV infection to daily oral hypericin. It is not known whether daily oral dosing will produce a tolerable prolonged exposure to therapeutic levels of hypericin. Pharmacokinetic modeling studies have demonstrated that daily oral dosing should produce a trough level in a desired range without excessive peak levels.
Details: It is not known whether daily oral dosing will produce a tolerable prolonged exposure to therapeutic levels of hypericin. Pharmacokinetic modeling studies have demonstrated that daily oral dosing should produce a trough level in a desired range without excessive peak levels. Cohorts of six patients each receive escalating doses of oral hypericin daily. Blood is sampled for peak and trough levels the second week of therapy. A computer modeling algorithm will use these levels to determine the appropriate dose needed for each patient to achieve the desired trough level. When three of six patients at a given dose have completed 3 weeks of therapy without evidence of dose-limiting toxicity, data will be reviewed to determine whether subsequent patients should be entered at the next higher dose. The MTD is defined as the dose level immediately below that at which grade 3 or worse toxicity is seen in three or more of six patients.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - PCP prophylaxis. Allowed: - Rifabutin, ketoconazole, fluconazole, and acyclovir, provided the medication has been taken for at least 4 weeks prior to study entry without toxicity. - Topical medications such as clotrimazole troches or nystatin suspension. Patients must have: - Documented HIV infection. - CD4 count <= 350 cells/mm3. - p24 antigen positive at >= 35 pcg/ml. - No active opportunistic infection at study entry that would require curative or suppressive therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Malignancy for which systemic chemotherapy is required. - Medically significant liver disease, orthostatic hypotension, hypertension, cardiac disease, seizure disorders, or lymphoma. - Any medical condition that would interfere with evaluation of the patient. Concurrent Medication: Excluded: - AZT, ddI, ddC, d4T, or any other antiretroviral medication. - Interferon or other immunomodulating drugs. - Cytotoxic chemotherapy. - Foscarnet. - Ganciclovir. - Antimycobacterial drugs other than rifabutin. - MAO inhibitors. - Hypertension-inducing, nephrotoxic, or hepatotoxic drugs. - Opiates. - Drugs known to cause photosensitivity. Prior Medication: Excluded within 1 month prior to study entry: - AZT, ddI, ddC, d4T, or any other antiretroviral medication. - Interferon or other immunomodulating drugs. - Cytotoxic chemotherapy. - Preparations known to contain hypericin. Excluded within 3 months prior to study entry: - Ribavirin. - Hyperforate (500 mg tablets or ampules for IV injection) manufactured by Kline. - Psychotonin M Alcohol Extract manufactured by Steigerwald. - Hypericin (40 mg vial) by VIMRx. Excluded within 14 days prior to study entry: - Foscarnet. - Ganciclovir. - Antimycobacterial drugs other than rifabutin. - MAO inhibitors. - Hypertension-inducing, nephrotoxic, or hepatotoxic drugs.
Total Enrollment: 24
Location and Contact Information:
Overall Study Official:
ValentineFT, Study Chair,
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Additional Information:
Study ID Numbers: ACTG 258;
Study Start Date:
Record last reviewed: November 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000792
Other Hiv Infections Studies:
1. A Study of AZT Plus Ganciclovir in Patients with AIDS and Cytomegalovirus (CMV) Infection
2. A Study to See if Certain Antioxidants and Vitamins Will Keep Lactate Levels Down in Patients Taking Anti-HIV Drugs
3. A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
4. A Study to Evaluate the Effects of Stopping Maintenance Therapy for Cytomegalovirus (CMV) Retinitis after Effective Anti-HIV Therapy
5. HIV in Specific Parts of the Body of Patients Who Are Changing or Starting Potent Anti-HIV Drugs
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A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects
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