The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP)

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: HIV Prevention Trials Network; National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Reverse Transcriptase Inhibitors; Tenofovir

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