A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00000645
• Date of registration: 02/11/1999
• Primary sponsor: National Institute of Allergy and Infectious Disease (NIAID)
• Public title: A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
• Scientific title: A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
• Date of first enrolment: July 2000
• Target sample size: 32
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00000645
• Study type: Interventional
• Study design: Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Valentine FT

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Hypericin

Secondary ID(s)

11125

ACTG 150

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

VIMRx Pharmaceuticals