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 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT01082692
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 infection
* On a stable HAART regimen for ≥3 months before the time of enrollment
* CD4-+ lymphocyte count ≥400 cells/μL on two occasions within 60 days of enrollment
* HIV-1 \< 75 copies/mL on two occasions within 60 days of enrollment
* Body mass index (BMI) ≤30 kg/m\^2
* Laboratory values obtained within 30 days prior to study entry:
* Hemoglobin \> 9 g/dL (female subjects) \> 9.5 g/dL (male subjects)
* Absolute neutrophil count \> 1000 cells/μL
* Platelet count \> 75,000/μL
* ALT, AST and alkaline phosphatase \< 2.5 x upper limit of normal range
* Total bilirubin \< 2.5 x upper limit of the laboratory normal range
* Serum creatinine \<1.5 mg/dL X upper limit of normal (ULN)
* Female subjects of reproductive potential must have a negative serum pregnancy test performed within 30 days of initiating the protocol-specified vaccination and a negative urine pregnancy test at Day 0 (enrollment)
* Ability and willingness of subject or legal guardian/representative to give written informed consent
Exclusion Criteria:
* Any active or past AIDS-defining illness with the exception of minimal (less than 10 lesions) cutaneous Kaposi's sarcoma
* History of a CD4+ T-cell count ≤200/μL
* Grade 2 or higher CPK laboratory result
* Use of any known immunomodulatory therapy within 4 weeks prior to study entry
* Any malignancy requiring systemic or local toxic chemotherapy. Local radiation will be allowed
* Pregnancy or breast-feeding
* Uncontrolled diabetes mellitus
* Major organ transplantation
* Active alcohol or substance abuse or psychiatric illness, which in the opinion of the investigator will interfere with adherence to study requirements
* Clinically significant neurological disorder occurring within 1 year prior to study entry
* Use of systemic corticosteroids for 4 weeks within 3 months prior to study entry
* Presence of any chronic disease that in the opinion of the investigator might affect subject safety
* History of previous vaccination with an HIV-1 vaccine except where documentation of placebo is available
* History of cardiac arrhythmia
* History or evidence of autoimmune disease
* Allergies to bupivacaine or similar anesthetic
* Metal implants at the site of injection
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness
* Any other conditions judged by the investigator that would limit the evaluation of a subject
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01082692
Study Brief:
Protocol Section:
NCT01082692