The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP)
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Daily dosing; Time-driven dosing; Event-driven dosing
Intervention description: A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate.; TDF/FTC twice weekly with a post-exposure dose; TDF/FTC as needed with a post exposure dose
Intervention MeSH terms: Tenofovir; Emtricitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One arm is daily TDF/FTC. One arm is twice weekly TDF/FTC with a post-exposure dose. One arm is as needed TDF/FTC with a post-exposure dose.
Masking: None (Open Label)
Enrollment: 622.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Administration Schedule; Nucleoside Reverse Transcriptase Inhibitors; Pharmacokinetics

Summary:

      Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of
      antiretroviral (ARV) medications before exposure to HIV. This study will examine the
      feasibility of different methods of dosing for a PrEP regimen. Three methods of delivery will
      be compared: daily, time-based, and event-based.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Literacy in one of the study languages (Thai, Xhosa, and/or English)

          -  Able to provide written informed consent

          -  Able to provide weekly telephonic updates

          -  Within 70 days of enrollment:

               1. Serum creatinine less than or equal to the upper limit of normal (ULN) and
                  calculated creatinine clearance of at least 70 mL/min by the Cockcroft-Gault
                  formula. More information on this criterion can be found in the protocol.

               2. Serum phosphate greater than or equal to the lower limit of normal (LLN)

               3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or
                  equal to 2 times ULN

               4. Hemoglobin greater than 10 g/dL

               5. Hepatitis B surface antigen (HBsAg)-negative

               6. Willing and able to provide adequate locator information

        Inclusion Criteria for MSM/TGW:

          -  Male at birth

          -  Reporting anal intercourse and/or receptive neovaginal intercourse with at least one
             man or transgender woman in the past 6 months

          -  One or more of the following risk factors for HIV acquisition in the past 6 months
             according to self-report: sexual intercourse with more than one man or transgender
             woman; history of an acute sexually transmitted infection (STI); sex in exchange for
             money, goods, or favors; condomless intercourse (oral, anal, vaginal, or neovaginal)
             with a partner known to be HIV-infected or of unknown HIV infection status according
             to self report

        Inclusion Criteria for Women Who Have Sex With Men (WSM):

          -  Female at birth or self identify as female

          -  Not pregnant or breastfeeding

          -  Not able to or not intending to become pregnant during the next year

          -  If able to become pregnant, self reported use of an effective method of contraception
             at Enrollment, and intending to use an effective method for the next 34 weeks

          -  One or more of the following risk factors for HIV acquisition in the past 6 months
             according to self report: sexual intercourse with more than one man; history of an
             acute STI; sex in exchange for money, goods or favors; condomless intercourse (oral,
             anal, or vaginal) with a partner known to be HIV-infected or of unknown HIV infection
             status

        Exclusion Criteria:

          -  Proteinuria 2+ or greater at screening

          -  Glucosuria 2+ or greater at screening

          -  Serious and active medical or mental illness

          -  One or both HIV rapid tests is reactive at screening or enrollment, regardless of
             subsequent HIV diagnostic test results

          -  Signs or symptoms suggestive of acute HIV infection

          -  Use of hypoglycemic agents for diabetes or agents with known nephrotoxic potential

          -  Use of ARV therapy (e.g., for post-exposure prophylaxis [PEP] or PrEP) in the 90 days
             prior to study entry

          -  Serum phosphate level below site laboratory LLN

          -  Current participation (or participation within 3 months of screening) in any HIV
             prevention study

          -  Previous or current participation in the active arm of an HIV vaccine trial

          -  Acute or chronic hepatitis B (HBV) infection (refers to chronic active HBV infection
             evidenced by a positive test for hepatitis B surface antigen (HBsAg)

          -  Presence of a psychological or social condition or an addictive disorder that would
             preclude compliance with the protocol

          -  Any other reason or condition that in the opinion of the investigator would interfere
             with participation, complicate interpretation of study outcome data, or otherwise
             interfere with achieving the study objectives