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 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT00016718
Eligibility Criteria:
Inclusion Criteria:
* HIV infected
* Antiretroviral naive OR have received no more than 56 days of drugs to prevent mother-to-child transmission of HIV OR have received less than 7 total days of antiretroviral therapy
* Viral load of 5,000 copies/ml or more
* Any Center for Disease Control (CDC) classification and immune status
* Able to swallow study medications
* Parent or guardian willing to provide informed consent, if applicable
* Willing to use acceptable forms of contraception
* female subjects of childbearing potential with a negative serum beta human chronic gonadotropin
Exclusion Criteria:
* Allergic to study medications or their formulations
* Kidney disease
* Positive for hepatitis B or C
* Acute opportunistic infection (OI) or bacterial infection requiring treatment at study entry
* Taking drugs to treat tuberculosis
* Taking anti-HIV drugs other than those included in this study
* Hemoglobin \>= grade 3 at screening
* Absolute Neutrophil counts \>= grade 2 at screening
* Platelets \>= Grade 2 at screening
* Bilirubin \>= Grade 2 at screening
* SGOT (AST), SGPT(ALT) \>= Grade 2 at screening
* Non-fasting triglycerides \>= Grade 2 at screening. Confirmed by a 2nd determination \>=100 mg/dl at fasting state
* Pancreatic amylase or total amylase+ lipase \>= Grade 2 at screening
* Taking any investigational drugs
* Anti-cancer drugs within 1 year of study screening
* Serious medical event within 21 days of study screening
* Active or history of pancreatitis
* Require certain medications. Patients requiring short courses of steroids (less than 14 days) for asthma are not excluded.
* Active or history of significant peripheral neuropathy
* Difficulty with food or severe chronic diarrhea within 30 days before study entry
* Unable to eat at least 1 meal per day (or to feed at least 3 times per day, for infants) because of chronic nausea, vomiting, swallowing problems, or stomach upset
* Unable to swallow oral medications
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
90 Days
Maximum Age:
21 Years
Study:
NCT00016718
Study Brief:
Protocol Section:
NCT00016718