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A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
This study has been completed.
Study NCT00000645   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes

November 2, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00000645 on ClinicalTrials.gov Archive Site
 
 
 
A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes

To determine the maximum tolerated dose (MTD) of hypericin, to define the types of toxicities that may be observed, and to determine what doses of the drug are associated with improvements in virological and immunological surrogate markers of HIV infection. To determine the bioavailability of synthetic hypericin given in 2 percent benzyl alcohol solution.

Hypericin is unlike other drugs presently being used to treat AIDS patients. Hypericin shows anti-HIV activity in test tube experiments.

Hypericin is unlike other drugs presently being used to treat AIDS patients. Hypericin shows anti-HIV activity in test tube experiments.

Each group of eight patients receives a given dose of hypericin by intravenous infusion. Doses are given three times per week for 8 weeks. When all eight patients at a dose level have been entered and four of the eight patients have completed 3 weeks of therapy without evidence of dose-limiting toxicity, additional patients may begin to receive drug at the next dose level. Concurrently, six patients wll participate in an oral-dosing bioavailability study. NOTE: The initial study was stopped secondary to an MTD being reached.

Phase I
Interventional
Treatment, Open Label
HIV Infections
Drug: Hypericin
 
Gulick RM, McAuliffe V, Holden-Wiltse J, Crumpacker C, Liebes L, Stein DS, Meehan P, Hussey S, Forcht J, Valentine FT. Phase I studies of hypericin, the active compound in St. John's Wort, as an antiretroviral agent in HIV-infected adults. AIDS Clinical Trials Group Protocols 150 and 258. Ann Intern Med. 1999 Mar 16;130(6):510-4.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
32
 
 

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Prophylaxis for Pneumocystis carinii pneumonia (required for patients with CD4+ < 200).
  • Symptomatic treatment with analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy.
  • Short courses (< 10 days) with ketoconazole or fluconazole for oral candidiasis or acyclovir for herpes lesions.
  • Topical medications such as clotrimazole troches or nystatin suspensions.

Concurrent Treatment:

Allowed:

  • Blood transfusions.

Patients must have HIV infection with CD+4 lymphocyte count of < 300 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded.

  • Kaposi's sarcoma requiring systemic therapy.

Concurrent Medication:

Excluded:

  • Continued use of opiates or drugs known to induce photosensitivity.

Patients with the following are excluded:

  • Active or chronic opportunistic infection at time of study entry that required curative or suppressive therapy.
  • Significant liver disease, orthostatic hypotension, cardiac disease, seizure disorder, lymphoma, hypotension.

Prior Medication:

Excluded:

  • Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), interferon, other antiretroviral agents or immunomodulating drugs within 1 month prior to study entry. Ribavirin within 3 months of study entry.
  • Ganciclovir (DHPG), antimycobacterial drugs, MAO inhibitors, hypertension-inducing, nephrotoxic, or hepatotoxic drugs within 14 days of entry.
  • Cytotoxic chemotherapy within 1 month prior to study entry.

Active substance abuse.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000645
 
ACTG 150
VIMRx Pharmaceuticals
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Valentine FT
National Institute of Allergy and Infectious Diseases (NIAID)
February 1995

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP