None listed
Conditions
Interventions
STUDY PARTICIPANTS WILL BE RANDOMIZED TO ONE OF SIX REGIMEN SEQUENCES (SEQUENCE 1-6). EACH SEQUENCE WILL CONSIST OF THREE EIGHT WEEK PERIODS OF STUDY PRODUCT ADMINISTRATION FOLLOWED BY AT LEAST A ONE-
Sponsors
INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. MALE OR TRANSGENDER FEMALE > AGE OF 18 AT SCREENING, VERIFIED PER SITE SOP 2. ABLE AND WILLING TO PROVIDE WRITTEN INFORMED CONSENT 3. HIV-1 UNINFECTED AT SCREENING AND ENROLLMENT, PER APPLICABLE ALGORITHM IN APPENDIX II 4. ABLE AND WILLING TO PROVIDE ADEQUATE LOCATOR INFORMATION, AS DEFINED IN SITE SOP 5. AVAILABLE TO RETURN FOR ALL STUDY VISITS, BARRING UNFORESEEN CIRCUMSTANCES AND WILLING TO COMPLY WITH STUDY PARTICIPATION REQUIREMENTS 6. IN GENERAL GOOD HEALTH AT SCREENING AND ENROLLMENT, AS DETERMINED BY THE SITE LOR OR DESIGNEE 7. PER PARTICIPANT REPORT, A HISTORY OF CONSENSUAL RAI AT LEAST ONCE IN THE PAST 3 MONTHS 8. PER PARTICIPANT REPORT AT SCREENING AND ENROLLMENT, AGREES NOT TO ENGAGE IN RECEPTIVE OR INSERTIVE SEXUAL ACTIVITY WITH ANOTHER STUDY PARTICIPANT FOR THE DURATION OF STUDY PARTICIPATION. 9. WILLING TO USE STUDY-PROVIDED CONDOMS FOR THE DURATION OF THE STUDY FOR PENETRATIVE INTERCOURSE 10. WILLING TO NOT TAKE PART IN OTHER RESEARCH STUDIES INVOLVING DRUGS, MEDICAL DEVICES, VACCINES OR GENITAL PRODUCTS FOR THE DURATION OF STUDY PARTICIPATION (INCLUDING THE TIME BETWEEN SCREENING AND ENROLLMENT)
Exclusion criteria
Exclusion criteria: 1. AT SCREENING, PARTICIPANT-REPORTED SYMPTOMS, AND/OR CLINICAL OR LABORATORY DIAGNOSIS OF ACTIVE ANORECTAL OR REPRODUCTIVE TRACT INFECTION REQUIRING TREATMENT PER CURRENT WORLD HEALTH ORGANIZATION (WHO) GUIDELINES OR SYMPTOMATIC URINARY TRACT INFECTION (UTI). INFECTIONS REQUIRING TREATMENT INCLUDE SYMPTOMATIC CHLAMYDIA TRACHOMATIS (CT) INFECTION, NEISSERIA GONORRHEA (GC), SYPHILIS, ACTIVE HERPES SIMPLEX VIRUS (HSV) LESIONS, ANOGENITAL SORES OR ULCERS, OR SYMPTOMATIC GENITAL WARTS. NOTE: HSV-1 OR HSV-2 SEROPOSITIVE DIAGNOSIS WITH NO ACTIVE LESIONS IS ALLOWED, SINCE TREATMENT IS NOT REQUIRED. IN CASES OF NON-ANORECTAL GC/CT IDENTIFIED AT SCREENING, ONE RE-SCREENING 2 MONTHS AFTER THE SCREENING VISIT WILL BE ALLOWED 2. HISTORY OF INFLAMMATORY BOWEL DISEASE AS REPORTED BY PARTICIPANT HISTORY 3. AT SCREENING: A. POSITIVE FOR HEPATITIS B SURFACE ANTIGEN B. POSITIVE FOR HEPATITIS C ANTIBODY C. HEMOGLOBIN 15,000 CELLS/MM3 F. CALCULATED CREATININE CLEARANCE LESS THAN 60 ML/MIN BY THE COCKCROFT-GAULT FORMULA WHERE CREATININE CLEARANCE IN ML/MIN = (140 - AGE IN YEARS) X (WEIGHT IN KG) X (1 FOR MALE)/72 X (SERUM CREATININE IN MG/DL)
Countries
Peru, Thailand, United States
Contacts
Public ContactJorge Sanchez
ASOCIACION CIVIL IMPACTA, SALUD Y EDUCACION
Outcome results
None listed