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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT00007202
Eligibility Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
* Have early HIV infection or show recent seroconversion (going from HIV-negative to HIV-positive).
* Are at least 18 years old.
* Agree to 2 barrier methods of birth control, if heterosexually active men or women, during the study and for 3 months after.
Exclusion Criteria
Patients will not be eligible for this study if they:
* Have received prior antiretroviral therapy.
* Have received interferons, interleukins, colony-stimulating factors, radiation, cytotoxic chemotherapy, or HIV vaccines within 30 days prior to study entry.
* Have had any experimental therapy within 30 days prior to study entry.
* Are pregnant or breast-feeding.
* Patients will not be eligible for Group I if they:
* Have had pancreatitis (inflammation of the pancreas).
* Have received alpha tocopherol (vitamin E), amiodarone, astemizole, carbamazepine, cisapride, ergotamine/diergotamine, estrogens, fluvastatin, glucocorticoids, itraconazole, ketoconazole, midazolam, phenobarbital, phenytoin, quinidine, rifampin, rifabutin, sildenafil, statin drugs (simvastatin, pravastatin, atorvastatin) used for reduction of triglyceride or cholesterol levels, terfenadine, triazolam, or warfarin within 14 days of study entry.
* Have received chloramphenicol, cisplatin, clioquinol, dapsone, diphenylhydantoin, disulfiram, ethionamide, glutethimide, gold, hydralazine, isoniazid, metronidazole, pyridoxine, sodium cyanate, thalidomide, vincristine, or zalcitabine within 30 days of study entry. In certain cases, patients taking these drugs may still be eligible.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00007202
Study Brief:
Protocol Section:
NCT00007202