ACTIVE_NOT_RECRUITING

Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical study is to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for prevention of HIV in the cisgender women in the US. The primary objectives of this study are: 1) to characterize the pharmacokinetics (PK) of LEN in United States (US) cisgender women; 2) to evaluate the safety of LEN and F/TDF for pre-exposure prophylaxis (PrEP) in US cisgender women; and 3) to evaluate the general acceptability of LEN injections and oral F/TDF in US cisgender women.

Official Title

A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in Cisgender Women in the United States

Quick Facts

Study Start:2023-11-17
Study Completion:2028-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06101329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Report at least 1 episode of condomless vaginal or anal sex with a cisgender man in the 12 months before enrollment.
  2. * Hepatitis B virus (HBV) surface antigen (HBsAg) negative.
  3. * Self-report one or more of the following in the past 12 months (except for incarceration, which could have occurred in the past 5 years):
  4. * Negative local rapid HIV-1/2 antibody (Ab)/antigen (Ag) test, central HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT).
  5. * Estimated glomerular filtration rate (GFR) at least 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr).
  1. * Self-reported history of previous positive results on an HIV test.
  2. * One or more reactive or positive HIV test result at screening or enrollment, even if HIV infection is not confirmed.
  3. * Past or current participation in HIV vaccine or HIV broadly neutralizing antibody study unless individual provides documentation of receipt of placebo (ie, not active product).
  4. * Prior use of long-acting systemic pre-exposure prophylaxis (PrEP) (including cabotegravir (CAB) or islatravir studies).
  5. * Acute viral hepatitis A or acute or chronic hepatitis B or C infection.
  6. * Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding, etc).

Contacts and Locations

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

UAB, 1917 Research Clinic
Birmingham, Alabama, 35222
United States
UCSD Antiviral Research Center (AVRC)
San Diego, California, 92103
United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
United States
Ponce de Leon Center Clinical Research Site
Atlanta, Georgia, 30303
United States
Fenway Health
Boston, Massachusetts, 02215
United States
Rutgers New Jesey Medical School - Clinical Research Center
Newark, New Jersey, 07103
United States
Cornell Clinical Trials Unit, New York Presbyterian Hospital - Weill Cornell Medicine
New York, New York, 10010
United States
Harlem Prevention Center CRS
New York, New York, 10027
United States
ICAP at Columbia University - Bronx Prevention Center
The Bronx, New York, 10451
United States
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Penn Prevention Research Unit
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Gilead Sciences

  • Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-17
Study Completion Date2028-10

Study Record Updates

Study Start Date2023-11-17
Study Completion Date2028-10

Terms related to this study

Additional Relevant MeSH Terms

  • Pre-Exposure Prophylaxis of HIV Infection