A5282. A RANDOMIZED PHASE II TRIAL TO COMPARE AN HPV TEST-AND-TREAT STRATEGY TO A CYTOLOGY-BASED STRATEGY FOR PREVENTION OF CIN 2+ IN HIV-INFECTED WOMEN.
- Registration Number
- PER-039-11
- Lead Sponsor
- El Instituto Nacional de Alergia y Enfermedades Infecciosas (NIAID) de los Estados Unidos,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 26
4.1.1 HIV-1 INFECTION, DOCUMENTED BY ANY LICENSED RAPID HIV TEST OR HIV ENZYME OR CHEMILUMINESCENCE IMMUNOASSAY (E/CIA) TEST KIT AT ANY TIME PRIOR TO STUDY ENTRY AND CONFIRMED BY A LICENSED WESTERN BLOT OR A SECOND ANTIBODY TEST BY A METHOD OTHER THAN THE INITIAL RAPID HIV AND/OR E/CIA, OR BY HIV-1 ANTIGEN, PLASMA HIV-1 RNA VIRAL LOAD.
NOTE: FOR SITES LOCATED IN COUNTRIES OTHER THAN THE UNITED STATES, THE TERM LICENSED REFERS TO A KIT THAT HAS BEEN CERTIFIED OR LICENSED BY AN OVERSIGHT BODY WITHIN THAT COUNTRY AND VALIDATED INTERNALLY.
WORLD HEALTH ORGANIZATION (WHO) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) GUIDELINES MANDATE THAT CONFIRMATION OF THE INITIAL TEST RESULTS MUST USE A TEST THAT IS DIFFERENT FROM THE ONE USED FOR THE INITIAL ASSESSMENT. A REACTVE INITIAL RAPID TEST SHOULD BE CONFIRMED BY EITHER ANOTHER TYPE OF RAPID ASSAY OR AN E/C1A THAT IS BASED ON A DIFFERENT ANTIGEN PREPARATION AND/OR DIFFERENT TEST PRINCIPLE (e.g., INDIRECT VERSUS COMPETITIVE), OR A WESTERN BLOT OR A PLASMA HIV-1 RNA VIRAL LOAD.
4.2.1 CURRENT PRIOR HISTORY OF CERVICAL, VAGINAL OR VULVAR CANCER.
4.2.2 PRIOR CERVICAL CRYOTHERAPY, LEEP, CERVICAL CONIZATION, OR TOTAL OR PARTIAL HYSTERECTOMY.
4.2.3 CERVICAL, VAGINAL OR VULVAR LESIONS THAT ARE SUSPICIOUS ON CLINICAL EXAM FOR CANCER.
4.2.4 VISUAL EVIDENCE OF BACTERIAL STIs OR SUSPICION OF PELVIC INFLAMMATORY DISEASE.
NOTE: CERVICITIS OR SUSPECTED PELVIC INFLAMMATORY DISEASE MUST BE TREATED WITH APPROPRIATE ANTIBIOTICS AT LEAST 7 DAYS PRIOR TO ENTRY.
4.2.5 PRIOR VACCINATION WITH AN HPV VACCINE.
4.2.6.HEMOPHILIA
4.2.7 CURRENTLY ON COAGULATION THERAPY OTHER THAN ACETYLSAJICYLIC ACID.
4.2.8 SERIOUS ILLNESS REQUIRING SYSTEMIC TREATMENT AND/OR HOSPITALIZATION WITHIN 21 DAYS PRIOR TO STUDY ENTRY.
4.2.9 ACTIVE DRUG OR ALCOHOL USE OR DEPENDENCE OR ANY OTHER CONDITION THAT, IN THE OPINION OF THE SITE INVESTIGATOR, WOULD INTERFERE WITH THE PARTICIPANT´S ABILITY TO ADHERE TO STUDY REQUIREMENTS.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method