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:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-25 @ 3:07 AM
NCT ID:
NCT00046033
Eligibility Criteria:
Inclusion Criteria:
* HIV-infection
* Viral load \>= 5000 copies/ml within 45 days prior to study entry
* Documented reduction in LPV sensitivity based on results obtained within 45 days prior to study entry
* Prior experience with 2 or more NRTIs for at least 6 months each
* At least 12 weeks of stable antiretroviral treatment that includes at least one PI prior to study entry and may include TDF and/or T-20 for 8 weeks or more immediately prior to study entry
* Negative pregnancy test within 14 days prior to study entry
* Agree not to become pregnant or to impregnate and to use an acceptable form of contraception while receiving study drugs and for 4 weeks after stopping study drugs
Exclusion Criteria:
* Pregnant or breast-feeding.
* Certain drugs within 14 days prior to study entry
* Nonnucleoside reverse transcriptase inhibitors (NNRTIs) within 14 days prior to study entry
* History of intolerance to LPV/r, RTV, or TDF and/or their components
* Drug or alcohol use that, in the opinion of the investigator, would interfere with the study
* Require therapy and/or hospitalization due to a serious infection or medical illness that is potentially life-threatening within 14 days prior to study entry
* Any condition that, in the opinion of the investigator, would compromise ability to participate in the study
* Unexplained fever for 7 consecutive days or chronic diarrhea within 30 days prior to study entry
* Cancer requiring chemotherapy
* Any immune system drugs, HIV vaccine, or other experimental therapy within 30 days prior to study entry
* Plan to use any PI other than APV, SQV, or LPV/r in the initial study treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00046033
Study Brief:
Protocol Section:
NCT00046033