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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT00498056
Eligibility Criteria:
Inclusion Criteria:
* At risk for HIV-1 sexual exposure within 24 weeks prior to study entry. More information about this criterion is available in the protocol.
* HIV uninfected within 6 weeks prior to study entry
* Willing to undergo HIV testing and counseling
* Willing to receive HIV test results
* Willing to use highly reliable method for contraception for at least the first 6 months of study
Exclusion Criteria:
* Participation in a clinical trial of another investigational product within 12 weeks prior to study entry
* Contraindication to intramuscular injections, history of bleeding disorder, or use of anticoagulant therapy in the 4 weeks prior to study entry
* Previously received an investigational HIV vaccine
* History of severe local or systemic reactogenicity to vaccines or severe allergic reactions or recurrent rash for unknown reasons in the 5 years prior to study entry
* Received an inactivated vaccine within the 2 weeks prior to study entry or of live attenuated within 4 weeks of study entry
* Received any blood products or any immunomodulatory agents within 12 weeks of study entry
* History of cancer. Participants with a history of localized squamous cell or basal cell carcinoma of the skin are not excluded.
* History of clinically significant autoimmune disease or immune deficiency syndrome
* Use of immunosuppressive medications within 24 weeks of study entry. Participants who have completed a short course of steroids more than 2 weeks prior to study entry, or using inhaled or topical steroids are not excluded.
* Seizure disorder. Participants who have had seizures with fever under the age of 2, seizures secondary to alcohol withdrawal more than 3 years prior to study entry, or a singular seizure more than 3 years ago that has not recurred or required treatment within the last 3 years are not excluded.
* Any medical condition or acute medical illness that, in the opinion of the investigator, would interfere with the study
* Pregnancy, plan to become pregnant, or breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00498056
Study Brief:
Protocol Section:
NCT00498056