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:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
NCT ID:
NCT00080106
Eligibility Criteria:
Inclusion Criteria
* HIV infected
* On a stable antiretroviral medication regimen (no changes to treatment within 4 weeks of study entry)
* Viral load less than 50 copies/ml
* Viral suppression for 2 years prior to study entry (documented viral loads less than 500 copies/ml)
* CD4 count of 500 cells/mm3 or greater
* Ad5 neutralizing antibody less than 200 units at screening
* Willing to stop antiretroviral medications for at least 16 weeks post-vaccination
* Hepatitis B surface antigen negative
* Weight more than 110 lbs
* Willing to use acceptable methods of contraception
Exclusion Criteria
* Two consecutive viral loads of 500 copies/ml or greater at least 14 days apart during the 24 months prior to study entry
* Two consecutive CD4 counts less than 200 cells/mm3 before starting antiretroviral medications
* History of anaphylaxis
* Allergy to vaccine components
* History of cardiac, pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurologic disease which, in the opinion of the study official, will compromise study participation
* Pregnancy or breastfeeding
* Contraindication to intramuscular injection, such as anticoagulant therapy or thrombocytopenia
* Immune globulin or blood products within 3 months prior to study entry
* Live vaccine within 30 days prior to study entry
* Inactivated vaccine within 14 days prior to study entry
* Previous HIV vaccine
* History of an AIDS-defining illness. Patients with a history of Kaposi's sarcoma limited to the skin may participate.
* Currently taking drugs or other substances not approved by the FDA. Patients may be on antiretroviral agents not yet approved by the FDA as part of a clinical trial or through an expanded access program.
* Immunomodulatory agents (interferon, IL-2, GM-CSF, systemic corticosteroids, etc.) within 30 days prior to study entry
* Active alcohol or substance abuse which may interfere with the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00080106
Study Brief:
Protocol Section:
NCT00080106