NCT00000792

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

January 1, 1995

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV Infections

Keywords

Administration, OralAcquired Immunodeficiency SyndromeAIDS-Related ComplexAntiviral Agents

Interventions

HypericinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess - East Campus A0102 CRS

Boston, Massachusetts, 02215, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Related Publications (2)

  • Furner V, Bek M, Gold J. A Phase I/II unblinded dose ranging study of hypericin in HIV-positive subjects. Int Conf AIDS. 1991 Jun 16-21;7(2):199 (abstract no WB2071)

    BACKGROUND

  • 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. doi: 10.7326/0003-4819-130-6-199903160-00015.

    PMID: 10075619BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

hypericin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Valentine FT

    STUDY CHAIR

  • Crumpacker C

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

January 1, 1995

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations

US(3)