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 @ 7:14 PM
Ignite Modification Date:
2025-12-24 @ 7:14 PM
NCT ID:
NCT00443703
Eligibility Criteria:
Inclusion Criteria:
* Patient is at least 18 years of age
* Patient is Human Immunodeficiency Virus (HIV) positive
* Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) \<50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen
* Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy
* Patient has no documentation of HIV RNA \>50 copies/mL for at least 3 months while on the KALETRA based regimen
Exclusion Criteria:
* Patient is or plans to become pregnant, or nursing a child
* Patient plans to donate eggs or impregnate/donate sperm
* Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy
* Patient is currently receiving a second protease inhibitor in addition to KALETRA
* Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids
* Patient has used another experimental HIV-integrase inhibitor
* Patient has a current (active) diagnosis of acute hepatitis due to any cause
* Patient has used systemic immunosuppressive therapy within one month prior to treatment in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00443703
Study Brief:
Protocol Section:
NCT00443703