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:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT00000667
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Acute use (\< 14 days) of acyclovir for Herpes simplex virus infections or ketoconazole for symptomatic Candida infections.
Patients must have the following:
* Asymptomatic HIV seropositivity.
* Patients with CD4 counts of 400 - 500 cells/mm3 must be informed of the recommended zidovudine (AZT) therapy and sign an informed consent statement declining AZT therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Systemic symptoms other than lymphadenopathy thought to be due to HIV infection including:
* Fatigue/malaise of \> 1 month duration that interferes with normal activities.
* Fever of \> 100 degrees F persisting for \> 15 in a 30-day interval without definable cause.
* Involuntary weight loss in excess of 10 pounds or \> 10 percent of normal weight within a 6-month interval.
* Diarrhea (\> 3 stools/day) persisting for more than 30 days without definable cause.
* Recurrent oral candidiasis.
* Multidermatomal herpes zoster.
* Biopsy proven hairy leukoplakia.
* Evidence of clinically significant central nervous system dysfunction as assessed by neurological exam.
Concurrent Medication:
Excluded:
* Antiretroviral agents of proven or potential efficacy.
* Any potential immunoenhancing or immunosuppressive drugs.
Patients with the following are excluded:
* Known hypersensitivity to insect cells or baculovirus.
* Abnormal chest x-ray taken within 3 months of study entry.
* Systemic symptoms other than lymphadenopathy thought to be due to HIV infection as listed in the patient exclusion coexisting diseases or complications.
* Evidence of clinically significant central nervous system dysfunction as assessed by neurological exam.
* Unwilling or unable to give written informed consent.
Prior Medication:
Excluded within 90 days of study entry:
* Zidovudine (AZT).
* Didanosine (ddI).
* Any potential antiretroviral.
* Immunomodulating agents.
Active substance abuse (either continuing daily alcohol abuse or intravenous drug use).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00000667
Study Brief:
Protocol Section:
NCT00000667