Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT00000792
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00000792
Study Brief:
Protocol Section:
NCT00000792