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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT00002233
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed with caution and/or careful monitoring:
* Drugs which may interact at CYP3A4 (e.g., alprazolam, carbamazepine, codeine, clarithromycin, dapsone, diazepam, diltiazem, erythromycin, estrogens, fluvastatin, glucocorticoids, imipramine, lidocaine, lovastatin, nifedipine, phenobarbital, phenytoin, simvastatin, and warfarin).
* Drugs that inhibit cytosolic alcohol dehydrogenase (e.g., ethanol, disulfiram, chlorzoxazone, chlorpromazine, isoniazid, and chloral hydrate).
* Drugs known to affect renal tubular secretion (e.g., probenecid or cimetidine), cause liver toxicity, or induce myelosuppression.
Patients must have:
* Documented and confirmed acute HIV-1 infection.
* No prior exposure to antiretroviral treatment.
* Ability to comply with the investigational nature of the study for a minimum of 48 weeks.
* Consent of parent or guardian if under the age of 18.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
* A clinical diagnosis of AIDS, excluding CD4+ cell counts less than 200/mm3.
* A serious medical condition such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that, in the opinion of the investigator, compromises the safety of the patient.
* Institutionalized or mentally disabled.
* Inability to comply with the dosing schedule and protocol evaluations for reasons other than those specified.
Concurrent Medication:
Excluded:
* Concurrent therapy with rifampin, rifabutin, terfenadine, astemizole, ketoconazole, itraconazole, cisapride, triazolam, midazolam, quinidine, amiodarone, and/or ergotamine/dihydroergotamine-containing regimens.
* Foscarnet or therapy with other agents with documented in vitro or in vivo activity against HIV-1.
* Medications known to induce or inhibit hepatic cytochrome P450 enzyme systems.
* Vitamin E supplements.
Concurrent Treatment:
Excluded:
* Dependence on blood transfusions.
* Other investigational treatments.
Patients with the following prior conditions are excluded:
* A history of clinically relevant pancreatitis or hepatitis within 6 months of study entry.
* A history of inflammatory bowel disease or malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction that might interfere with drug absorption or render the patient unable to take oral medication.
* An unexplained fever above 38.5 Celsius for more than 14 days within 30 days of study entry.
* A history of coagulopathy.
Prior Medication:
Excluded:
* Prior exposure to antiretroviral therapy.
* Therapy with immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents or interferons, cytotoxic chemotherapeutic agents, or anti-oxidants within 30 days of study entry.
Prior Treatment:
Excluded:
\- Radiation therapy within 30 days of study entry.
Risk Behavior:
Excluded:
Alcohol or illicit drug use which, in the opinion of the investigator, may interfere with ability to comply with the dosing schedule and protocol evaluations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT00002233
Study Brief:
Protocol Section:
NCT00002233