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 @ 4:22 PM
Ignite Modification Date:
2025-12-24 @ 4:22 PM
NCT ID:
NCT00621166
Eligibility Criteria:
Inclusion Criteria:
* Documented positive test for HIV-1 infection
* Subject is at least 18 and not older than 40 years of age at the day of the first dosing of study medication
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
* Pregnant for a maximum of 30 weeks at the day of first dosing of study medication
Exclusion Criteria:
* History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the trial.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* Inability to understand the nature and extent of the trial and the procedures required.
* Abnormal serum transaminases or creatinine, determined as levels being \> 3 times upper limit of normal.
* Concomitant use of medications that interfere with Generic lopinavir/ritonavir pharmacokinetics
* Active hepatobiliary or hepatic disease (N.B. chronic hepatitis B/C co-infection is allowed)
* Documented previous virological failure of a lopinavir/ritonavir containing regimen or documented resistance to lopinavir/ritonavir prior to dosing
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00621166
Study Brief:
Protocol Section:
NCT00621166