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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT00002203
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* HIV infection documented by a licensed antibody ELISA assay and confirmed by Western blot, positive HIV blood culture, positive HIV serum antigen, or plasma viremia.
* CD4+ cell count of at least 300 cells/mm3.
* HIV-1 RNA less than 10,000 copies/ml by Roche Amplicor PCR assay.
* CDC Category A or B Classification for HIV infection (no clinical diagnosis of AIDS).
* Compliance with dosing schedule and protocol evaluations.
Prior Medication:
Required:
* 3TC at 150 mg bid, ZDV at 600 mg/day (200 mg tid or 300 mg bid), plus a marketed protease inhibitor (ritonavir, saquinavir, indinavir, or nelfinavir) at its recommended dose for at least 10 weeks.
Allowed:
* Inhaled corticosteroids for the treatment of asthma.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Malabsorption syndromes affecting drug absorption (e.g., Crohn's disease and chronic pancreatitis).
* Enrollment in other investigational protocols.
Concurrent Medication:
Excluded:
* Cytotoxic chemotherapeutic agents.
* Nonnucleoside reverse transcriptase inhibitors.
* Other investigational agents.
Concurrent Treatment:
Excluded:
Radiation therapy.
Prior Medication:
Excluded:
* Cytotoxic chemotherapeutic and immunomodulating agents such as systemic corticosteroids, IF-2, alpha-IFN, beta-IFN, or gamma-IFN (except for inhaled corticosteroids for the treatment of asthma) within 4 weeks of study entry.
* HIV immunotherapeutic vaccine within 3 months of study entry.
Prior Treatment:
Excluded:
Radiation therapy within 4 weeks of study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002203
Study Brief:
Protocol Section:
NCT00002203