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 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT00335192
Eligibility Criteria:
Inclusion Criteria:
1. HIV+ patients aged above 18 years.
2. Undetectable HIV viral load in the last determination
3. Patients capable of correct compliance according to clinical criteria.
4. Patients on triple HAART therapy for the previous 3 months including 3TC and/or ABV and TDF, with a PI (Lopinavir/ritonavir) or an NNRTI (Nevirapine)
5. Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.
6. Ability to provide informed consent.
Exclusion Criteria:
1. Incorrect therapeutic compliance over the four weeks before the beginning of the study.
2. Interruption or withdrawal from therapy during follow-up.
3. Concomitant treatment with any drug which according to the clinician's criterion may interact with the investigational antiretrovirals, such as other antiretrovirals.
4. Triple HAART therapy including Nevirapine (for phase II)
5. Documented or suspected resistance to ABV, 3TC or lopinavir/rtv (for phase II).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00335192
Study Brief:
Protocol Section:
NCT00335192