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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT00280969
Eligibility Criteria:
Inclusion Criteria:
* serological diagnosis of HIV infection
* male aged over 20 years old
* CD4 at enrollment between 100 to 300
* body weight over 40kg
* enable to obtain the written informed consent
Exclusion Criteria:
* Patients who are considered unable to complete 48 weeks of study by their physician.
* Patients who have gastrointestinal symptom which may interfere the absorption of antiretrovirals, or have swallowing problems.
* Patients who have the history of hypersensitivity with lamivudine.
* Hepatitis B carrier.
* Blood test results within 4 weeks prior to the randomization; hemoglobin less than 9g/dl, platelet less than 50,000/mm3, neutrophils less than 1000/mm3, serum total bilirubin more than 2.0mg/dl, GOT/GPT/LDH more than two times of upper normal limit, serum creatinine more than 1.2mg/dl.
* Patients who have had radiation or chemotherapy within 4 weeks prior to the randomization or will have the treatment during the study .
* Patients who have had immunomodulating agent such as systemic use of corticosteroid or interferon within 4 weeks prior to the randomization. Inhaled corticosteroid is the exception.
* Patients who have diabetes, congestive heart failure, cardiomyopathy, or other serious medical condition.
* Patients with AIDS defining illness.
* Patients with known resistant strains to efavirenz, atazanavir, ritonavir, lamivudine and abacavir prior to the study.
* Patients with acute retroviral syndrome.
* Patients with psychiatric disorder.
* Patients whose physician consider the study enrollment inappropriate.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Study:
NCT00280969
Study Brief:
Protocol Section:
NCT00280969