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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT00006320
Eligibility Criteria:
INCLUSION CRITERIA:
HIV-1 positive as documented by ELISA and confirmed by Western Blot test
Positive urine pregnancy test or positive serum Beta-HCG
Age greater than or equal to 18 years
At least 14-week gestation at the time of screening as estimated by the subject's obstetrician
Having a normal pregnancy per the subject's obstetrician's assessment
Maintained on or to be started on a HAART regimen containing at least three antiretroviral agents
Hgb greater than or equal to 10 gm/dL, platelet greater than or equal to 100,000/mL, PT less than or equal to 14.0 sec
S.Cr. less than 2.0 mg/dL, ALT and AST less than or equal to 2 times the upper limit of normal
EXCLUSION CRITERIA:
Receiving treatment for an active HIV-related opportunistic infection
Significant medical conditions such as diabetes (including gestational diabetes), hypertension, coronary artery disease, seizure disorder, asthma, or other medical conditions that in the investigators' opinion will not be safe for the subject to participate in this study
History of significant obstetric complications during prior pregnancy(ies)
Concurrent illicit drug or alcohol abuse
Not receiving ongoing medical care for HIV infection and pregnancy
Efavirenz as part of HAART regimen
Combination of didanosine and stavudine as part of HAART regimen
Presence of persistent diarrhea or history of malabsorption that will interfere with the subject's ability to absorb the antiretroviral drugs
Refusal to allow the investigators to obtain medical records from her HIV care provider and her obstetricians during the course of the study
Unable to obtain venous access for blood draw
Refusal to agree to allow the specimen to be stored for future research
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00006320
Study Brief:
Protocol Section:
NCT00006320