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 @ 12:55 PM
Ignite Modification Date:
2025-12-24 @ 12:55 PM
NCT ID:
NCT00152061
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 seropositive patients \>= 18 years of age
* Willingness and ability to understand and sign a written informed consent and comply with the protocol procedure
* Prior treatment with nucleoside reverse transcriptase inhibitors (NRTI's), non-nucleoside reverse transcriptase inhibitors (NNRTI's) and protease inhibitor (PI)-containing regimens
* On a stable PI and 3TC or FTC -containing regimen for \>= 2 months
* Plasma HIV-1 RNA \>5000 copies/ml
* CD4 \>100
* Documented M184V or I on genotype within 3 months of study entry
* At least 3 PI-associated resistance mutations on genotype within 3 months of study entry, (including known resistance mutations at codons 10, 30, 46, 50, 54, 71, 82, 84, and 90)
Exclusion Criteria:
* In the opinion of the investigator a patient that is either unwilling or unable to be adherent to antiretroviral drugs
* Requirement for concomitant treatment with medicines that interfere with the therapy prescribed in the study
* Patients who have never taken 3TC or FTC, or with no prior documentation of the M184V mutation
* Active hepatitis B infection
* Vaccination within 2 weeks of entering the study
* An acute opportunistic illness within 4 weeks of entering the study; chronic infections will not be excluded
* Use of immunomodulatory medications such as IL-2
* Planned use of enfuvirtide, (T20) in salvage regimen, (in T20 naïve subjects)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00152061
Study Brief:
Protocol Section:
NCT00152061