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 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT01737359
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥ 18 years old with HIV-1 RNA ≥ 2,000 copies/mL and currently failing therapy.
* Has M184I/V mutation in addition to 0-2 thymidine analog mutations (TAMs) at screening.
* Agree to be abstinent or use two reliable forms of contraception (for females) and one form for men when participating in sexual activity that could result in pregnancy.
Exclusion Criteria:
* Current or recent (last 30 days of study entry) AIDS defining diseases.
* Genotypic resistance testing at screening indicating K65R, L74V, Q151M mutation.
* Prior exposure to lopinavir/ritonavir or amdoxovir.
* Impaired hepatic function (ALT \> 5 x ULN).
* Women who are pregnant or breast feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01737359
Study Brief:
Protocol Section:
NCT01737359