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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT00950859
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 infected male or female adults at least 18 years of age with a plasma HIV-1 RNA \> 1,000 copies/mL at study entry. Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol)
* ART-experienced (defined as on stable ART for at least the last 2 months) and is either currently experiencing virologic failure to RAL or experienced virologic failure to RAL \> 8 weeks prior to Screening
* Must have documented RAL genotypic resistance on study entry genotype
* Must have documented genotypic or phenotypic resistance to at least one drug from each of three or more of all approved classes of ART
* For Cohort II, Subjects MUST be able to receive at least one fully active drug as part of the Day 11 optimised background regimen
* Willing and able to understand and provide signed and dated written informed consent prior to screening
Exclusion Criteria:
* Any pre-existing mental, physical, or substance abuse disorder which, which could compromise ability to comply with the protocol or compromise subject safety
* Women who are pregnant or breastfeeding
* An active AIDS-defining condition at the screening visit
* Currently take and/or anticipated need for EFV, NVP, FPV/RTV or TPV/RTV during the study
* Treatment with any of the following medications within 15 days of starting study drug, or anticipated to need, during the course of the study: Etravirine (unless co-administered with LPV/RTV or DRV/RTV), rifampin, rifabutin, phenytoin, phenobarbital, barbiturates, glucocorticoids, modafinil, oxcarbazepine, pioglitazone, troglitazone, carbamazepine, St. Johns wort
* Previous participation in an experimental drug and/or vaccine trial(s) within 30 days or 5 half-lives
* History of ongoing or clinically relevant pancreatitis or hepatitis within the previous 6 months
* Expected to require treatment for HCV infection during the first 24 weeks of the study
* Evidence of cirrhosis with or without hepatitis viral co-infection
* History of upper gastrointestinal bleed and/or active peptic ulcer disease
* Screening haemoglobin \<10g/dL (100g/L)
* Subject suffers from a serious medical condition which could compromise the safety of the subject.
* Any condition that could interfere with the absorption, distribution, metabolism or excretion of the drug or render the subject unable to take oral medication
* Screening lipase 3 times the upper limit of normal (ULN)
* Any acute or Grade 4 laboratory abnormality at screening
* Screening alanine aminotransferase (ALT) \>5xULN
* Screening ALT 3xULN and bilirubin 1.5xULN (with 35% direct bilirubin)
* Personal or family history of prolonged QT syndrome.
* Any clinically significant finding, as specified in the protocol, on screening or baseline electrocardiograph (ECG)
* History of allergy to the study drugs or their components or drugs of their class
* Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to screening, or future need of treatment with these agents during the study
* Treatment with immunomodulators within 28 days prior to screening or subject has received an HIV-1 vaccine within 90 days prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00950859
Study Brief:
Protocol Section:
NCT00950859