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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00000760
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Chemoprophylaxis for P. carinii pneumonia, TB, and mucocutaneous candidiasis.
* Methadone maintenance.
* Hormonal contraceptives.
Patients must have:
* HIV-1 seropositivity.
* CD4 count 50 - 500 cells/mm3.
* Life expectancy of at least 24 weeks.
* Stable weight (+/- 2 kg) by 28 days prior to study entry (by history).
NOTE:
* At least 50 percent of patients must be p24 antigen positive (\>= 50 pg/ml).
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
* Known or suspected hypersensitivity to benzodiazepines.
* Presence of any malignancy other than basal cell carcinoma or limited cutaneous Kaposi's sarcoma (defined as no more than five lesions with no mucosal involvement).
* Ongoing diarrhea, defined as more than 2 liquid stools per day.
* History, physical exam, or laboratory results consistent with a subclinical AIDS-defining opportunistic infection.
* Grade 2 or greater signs and symptoms of AIDS Dementia Complex.
* Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, dermatologic, or allergic disease.
Concurrent Medication:
Excluded:
* Chronic suppressive therapy for CMV, MAI, toxoplasmosis, cryptococcosis, cryptosporidiosis, coccidioidomycosis, and histoplasmosis.
* ddC, ddI, AZT (except for control groups) or other experimental antiretrovirals or immunomodulating agents.
* Other medications excluded from the study.
Patients with the following prior conditions are excluded:
* History of serious adverse reactions to benzodiazepines.
* History of intolerance to AZT at 600 mg/day or less or ddI at 400 mg/day or less.
* History of unexplained fever, defined as a temperature of 38.5 deg C or greater with or without night sweats for more than 7 of the past 28 days.
Prior Medication:
Excluded:
* Benzodiazepines within 14 days prior to study entry.
Active drug or alcohol abuse that would interfere with study compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00000760
Study Brief:
Protocol Section:
NCT00000760