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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT00006066
Eligibility Criteria:
Inclusion Criteria
A child may be eligible for this trial if he/she:
* Is HIV-positive.
* Is 2 to 18 years old (consent of parent or guardian required if under 18).
* Has received 12 or more weeks of anti-HIV drug therapy, consisting of at least 3 drugs. This combination may include a nucleoside reverse transcriptase inhibitor (NRTI), a nonnucleoside reverse transcriptase inhibitor, or a protease inhibitor, or 3 NRTIs. Combinations of NRTIs may not include abacavir (ABC). Patients may have taken ABC if it was not in combination with 2 other NRTIs. (This reflects a change in the requirement for anti-HIV therapy.)
* Has a plasma HIV RNA level of less than 10,000 copies/ml.
* Has evidence of a weakened immune system (based on CD4 cell counts and absolute CD4 percentage less than 25 percent). (This reflects a change in how a weakened immune system is defined.)
* Has a parent or guardian who is willing to comply with study requirements.
* Has symptoms of HIV infection.
Exclusion Criteria
A child will not be eligible for this study if he/she:
* Has an active opportunistic (AIDS-related) infection.
* Is pregnant.
* Is taking certain medications, such as steroids or other drugs that affect the immune system, within 6 weeks prior to study entry.
* Is taking ABC.
* Is taking certain antibodies.
* (Exclusion criteria reflect changes.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT00006066
Study Brief:
Protocol Section:
NCT00006066