Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR

HIV Prevention Trials Network

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: HIV Infections; Pregnancy

Treatments: Drug: DPP; Drug: 2PR; Drug: Free Choice

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT07288190

HPTN 104

UM1AI068619 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

To evaluate adherence to a single dual-prevention pill (DPP) compared with a two-pill regimen (2PR) for pre-exposure prophylaxis (PrEP) and pregnancy prevention in women without HIV.

Full description

To evaluate adherence to a single DPP consisting of co-formulated Tenofovir Disoproxil Fumarate and Emtricitabine (FTC/TDF) plus combined ethinyl estradiol/levonorgestrel oral contraceptive (COC), compared with a two-pill regimen (2PR) consisting of daily oral FTC/TDF pill and combined COC pill, for pre-exposure prophylaxis PrEP and pregnancy prevention in women without HIV.

Enrollment: 300 estimated patients

Sex: Female

Ages: 16 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 16 through 39 years old (inclusive) at Screening.
• Adults must be able and willing to provide informed consent. Adolescents (16- and 17-year-olds) will be consented according to applicable local guidelines, by obtaining participant assent and where applicable parental or guardian permission.
• Able and willing to provide adequate locator information.
• Able and willing to comply with all study procedures.
• Must be post-menarche and pre-menopausal and could potentially become pregnant.
• Sexually active, defined as having had penile-vaginal sex within the 3 months before Screening (per self-report)
• Negative pregnancy test at Screening and Enrollment.
• Does not intend to become pregnant within the next 12 months.
• Willing to use COCs for at least 48 weeks as their method of contraception.
• HIV negative at Screening and Enrollment.
• Willing to use oral PrEP for at least 48 weeks.
• Hepatitis B (HBV) surface antigen (HbsAg) negative per blood test at Screening.
• Hepatitis C (HCV) negative at Screening.
• Normal estimated creatinine clearance (eCrCl) ≥ 60 ml/min per blood test at Screening.

Exclusion criteria

• Intolerance, adverse reaction, or laboratory abnormality associated with PrEP use in the past.
• Unable to become pregnant e.g., had a tubal ligation or hysterectomy or otherwise lacks a uterus, or is currently using another form of contraception.
• Medically ineligible for combined hormonal contraception and specifically COCs per World Health Organization (WHO) medical eligibility criteria for contraceptive use or similar local medical eligibility guidelines (e.g., Centers for Disease Control and Prevention eligibility criteria).
• Medically ineligible for PrEP based on WHO and/or local guidelines.
• Using or planning to use another pregnancy prevention product other than oral contraception (condoms are permitted) during the next 48 weeks.
• Using or planning to use another HIV prevention product other than condoms during the next 48 weeks.
• Any other condition the clinician feels would jeopardize the health and wellbeing of the participant

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

DPP/2PR/Choice

Experimental group

Description:

Daily DPP for 12 weeks followed by daily 2PR for 12 weeks followed by 24 weeks of Choice

Treatment:

Drug: Free Choice

Drug: 2PR

Drug: DPP

2PR/DPP/Choice

Experimental group

Description:

Daily 2PR for 12 weeks followed by daily DPP for 12 weeks followed by 24 weeks of Choice

Treatment:

Drug: Free Choice

Drug: 2PR

Drug: DPP