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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT00000892
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Required:
* Chemoprophylaxis for Pneumocystis carinii pneumonia for all patients who have a CD4 cell count of equal or less than 200 cells/mm3.
Allowed:
* Topical and oral antifungal agents except ketoconazole and itraconazole.
* Treatment, maintenance or chemoprophylaxis with approved agents for opportunistic infections.
* Antibiotics.
* Systemic corticosteroids for 21 days or less for acute problems.
* Recombinant erythropoietin (rEPO) and granulocyte-colony stimulating factor (G-CSF, filgrastim).
* Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives (not as a sole form of birth control), megestrol acetate, or testosterone.
* Alternative therapies, such as vitamins, acupuncture, and visualization techniques.
* \[AS PER AMENDMENT 3/30/98: Calcium channel blockers may be used only with caution.\]
Patients must have:
* HIV-1 infection documented by a licensed ELISA and confirmed by Western blot, HIV culture, HIV antigen, plasma HIV RNA, or a second antibody test other than ELISA.
* 2,000 to 200,000 HIV-1 RNA copies/ml as measured by any Roche-certified laboratory \[AS
PER AMENDMENT 3/30/98:
* using the Roche Amplicor HIV-1 Monitor\] within 30 days of study entry.
* Signed, informed consent from parent or legal guardian for patients less than 18 years of age.
Prior Medication: Required:
* More than 6 months cumulative indinavir therapy.
* Stable indinavir-containing antiretroviral regimen for at least 4 weeks \[2 weeks AS PER AMENDMENT 3/30/98\] prior to study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Any active infection requiring acute treatment within 30 days \[21 days AS PER AMENDMENT 3/30/98\] prior to study entry.
* Unexplained temperature greater than 38.5 degrees for any 7 consecutive days within 30 days prior to study entry.
* Malignancy, including Kaposi's sarcoma, that requires systemic chemotherapy.
Concurrent Medication:
Excluded:
* Non-protocol-specified immunomodulatory and/or antiretroviral agents.
* Systemic cytotoxic chemotherapy.
* Ketoconazole, itraconazole, rifampin, rifabutin, alprazolam, amiodarone, astemizole, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam, encainide, estazolam, flecainide, flurazepam, isotretinoin, meperidine, midazolam, piroxicam, propafenone, propoxyphene, quinidine, terfenadine, triazolam, zolpidem, phenytoin, phenobarbital, carbamazepine, and ergot alkaloids and \[ AS PER AMENDMENT 3/30/98: dexamethasone, ergot derivatives, and pimozide\].
Avoided:
* Herbal medications.
Prior Medication:
Excluded:
* At least 2 weeks or more total ritonavir and/or saquinavir (hard gelatin capsule).
* NNRTIs (nevirapine, delavirdine, DMP-266, etc.), saquinavir (soft gelatin capsule), nelfinavir, 141W94VX-478, and adefovir dipivoxil.
* Immunomodulator \[systemic immunomodulator AS PER AMENDMENT 3/30/98\] or investigational drug therapy within 30 days prior to entry.
* Active immunization within 30 days \[21 days AS PER AMENDMENT 3/30/98\] prior to entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00000892
Study Brief:
Protocol Section:
NCT00000892