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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT00002368
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* Documented HIV infection.
* CD4+ cell count \<= 200 cells/mm3.
* Life expectancy \> 3 months.
* Written informed consent from parent or guardian for patients \< 18 years of age.
* Willingness and ability to follow protocol requirements.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following conditions or symptoms are excluded:
Patient is enrolled or plans to enroll during the course of this study in another clinical study of an antiretroviral or other agent used to treat HIV-1 infection.
* NOTE:
* Patients are allowed to participate in opportunistic infection clinical studies if the investigational agent is not contraindicated for the study.
Concurrent Medication:
Excluded:
* Patient is receiving therapy with an antiretroviral agent other than ZDV, d4T, ddI, ddC, or 3TC.
* Patient is receiving acute therapy for a clinical AIDS progression event such as systemic chemotherapy.
* Dicumarol, Warfarin and other anticoagulant medications.
* Tolbutamide.
* Investigational drugs (unless included in opportunistic infection clinical trial) and all antiretroviral agents (excluding ZDV, ddC, ddI, d4T and 3TC).
* Neurotoxic drugs.
* Cimetidine.
* Erythromycin.
Concurrent Treatment:
Excluded:
Radiation therapy.
Patients with any of the following prior conditions and symptoms are excluded:
History of clinically important disease other than HIV-1 infection or related diseases that, in the opinion of the investigator, may put the patient at risk because of participation in this study.
Prior Medication:
Excluded:
* Patient has received prior therapy with Viramune or any other non-nucleoside reverse transcriptase inhibitor.
* Patient has received any immunosuppressive or cytotoxic drugs or any other experimental agent within 4 weeks prior to study day 1.
* Patient has received treatment with erythromycin, coumadin/warfarin, phenobarbital, amoxicillin/clavulanic acid, or ticarcillin/clavulanic acid within 2 weeks prior to study day 0.
Risk Behavior:
Excluded:
Patients who are active chronic alcohol or substance abusers or have an active psychiatric condition sufficient to impair compliance with protocol requirements.
Required:
Patient must be receiving stable nucleoside therapy with at least one agent for \>= 4 weeks prior to study day 0. Zidovudine (ZDV), Zidovudine + Dideoxycytidine (ddC), or Zidovudine + Didanosine (ddI) must be used unless prior intolerance precludes ZDV use. Stable use means no change in dose \> 50% for any background nucleoside within four weeks prior to study day 0.
NOTE:
* If patient is ZDV intolerant, ddC, ddI or D4T monotherapy is allowed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00002368
Study Brief:
Protocol Section:
NCT00002368