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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT00004735
Eligibility Criteria:
Inclusion Criteria
* HIV infected
* CD4 percentage less than 15%
* Beginning an anti-HIV drug regimen (HAART) that includes at least 3 drugs. Two of the drugs must be new to the patient. One of the new drugs must be a protease inhibitor or a nonnucleoside reverse transcriptase inhibitor (NNRTI). As of May 2005, patients who have previously taken NNRTIs will have the option of taking Fuzeon as an alternative component of their HAART regimen
* Consent of parent or legal guardian
* As of May 2005, females who become pregnant during the study can continue to participate as long as they become pregnant after receiving all vaccinations
Exclusion Criteria
* Active opportunistic (AIDS-related) or bacterial infection
* Cancer
* Immunity to hepatitis A
* Severe drug toxicity
* Previous severe or allergic reaction to tetanus vaccine
* Taking IVIG, IL-2, or other drugs which affect the immune system
* Taking hydroxyurea
* Pregnancy at screening visit
* Pregnancy before all vaccinations have been administered
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
24 Years
Study:
NCT00004735
Study Brief:
Protocol Section:
NCT00004735