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 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT00766818
Eligibility Criteria:
Inclusion Criteria:
* HIV positive
* Pregnant (\<22 weeks)
* Currently taking or planning to start Kaletra
* ≥18 years of age
Exclusion Criteria:
* Active opportunistic or serious bacterial infection at the time of entry
* Past or present obstetrical complications (including, but not limited to: placentia previa, eclampsia, confirmed birth defects, multiple gestation pregnancies)
* Unable to maintain medication adherence, defined as ≥ 80% of doses taken between visits
* Currently receiving or expected to receive other protease inhibitors in conjunction with Kaletra®
* HIV genotype showing accumulation of protease inhibitor mutations expected to result in virologic failure on Kaletra® OR documented virologic failure on Kaletra®-containing regimen attributable to the Kaletra® component
* Chronic hepatitis B and/or C virus infection
* Cushing's Syndrome
* Untreated hypothyroidism or hyperthyroidism
* Serum Creatinine \> 1.5 mg/dL
* Amylase 1.5 times ULN and/or abnormal lipase
* Direct or total bilirubin levels \> Grade 1
* ALT/AST \> Grade 2 (based on the NIH Division of AIDS (DAIDS) Table for Grading the Severity of Adverse Events
* Bicarbonate \> Grade 2 (DAIDS)
* Hematology \> Grade 2 (DAIDS), except for anemia: exclude only women with Hb\< 9 g/dL and/or HCT , 27.3% (\< 8.5 mg/dL and/or HCT , 25.6% if currently on ZDV) at screening; all subjects with anemia who enroll in the study must be receiving or start hematinics, including iron and folate supplements, immediately upon enrollment and continue until anemia resolves or end of pregnancy. The hematinic supplements may be discontinued at the discretion of the investigator if they consider continuation would not be in the best interest of the subject.
* Receiving the following drugs: astemizole, terfenadine, rifampin, cisapride, ergot derivatives, simvastatin, lovastatin, St. John's wort, pimozide, midazolam, triazolam, carbamezapine, phenobarbital, phenytoin, or dexamethasone
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00766818
Study Brief:
Protocol Section:
NCT00766818