A PHASE 2 RANDOMIZED SEQUENCE OPEN LABEL EXPANDED SAFETY AND ACCEPTABILITY STUDY OF ORAL EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLET AND RECTALLY-APPLIED TENOFOVIR REDUCED-GLYCERIN 1 % GE

Not Applicable

• Registration Number: PER-099-12
• Lead Sponsor: INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-04
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 38

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

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 < 10.0 G/DL
D. PLATELET COUNT LESS THAN 100,000/MM3
E. WHITE BLOOD CELL COUNT < 2,000 CELLS/M M3 OR > 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified