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Clinical Trials/PACTR202003492130332
PACTR202003492130332
Not yet recruiting
Phase 3

A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women

Division of HIV and AIDS0 sites200 target enrollmentStarted: February 17, 2020Last updated:
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ConditionsHIV/AIDS

Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Division of HIV and AIDS
Enrollment
200
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
19 Year(s) to 44 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •Born female
  • •18\-45 years at the time of screening
  • •Willing and able to provide informed consent
  • •Willing and able to undergo all required study procedures
  • •Non\-reactive HIV test results at Screening and Enrollment\*
  • •Sexually active (i.e., vaginal intercourse on a minimum of two separate days in the 30 days prior to Screening)
  • •Score of \>5 using a modified VOICE risk score51
  • •No plans to re\-locate or travel away from the site for \>8 consecutive weeks during study participation
  • •Creatinine clearance \=60 mL/min (using Cockcroft\-Gault equation) (use sex at birth for calculation)
  • •Although not protocol exclusionary, sites should carefully consider the advisability of enrolling participants with calculated creatinine clearance between 60\-70 mL/min, as limited changes in creatinine clearance during study conduct will lead to protocol\-mandated product holds and may alter the risk\-benefit considerations of study participation

Exclusion Criteria

  • •One or more reactive HIV test results at Screening or Enrollment, even if HIV infection is not confirmed
  • •Pregnant or currently breastfeeding, or intends to become pregnant and/or breastfeed during the study • Co\-enrollment in any other HIV interventional research study (provided by self\-report or other available documentation), with one exception: IMPAACT 2026 (co\-enrollment in IMPAACT 2026 is permitted for participants who become pregnant) • Current or past enrollment in an HIV vaccine or broadly neutralizing antibody trial • Current or chronic history of liver disease (e.g., non\-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy)
  • •HPTN 084, FINAL, Version 2\.0 46 of 150
  • •6 November 2019
  • •History of seizure disorder, per self\-report
  • •Clinically significant cardiovascular disease, as defined by history/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease
  • •Inflammatory skin conditions that compromise the safety of IM injections, per the discretion of the Investigator of Record (IoR). Mild skin conditions may not be exclusionary at the discretion of the IoR or designee
  • •Has a tattoo or other dermatological condition overlying the buttock region which in the opinion of the IoR or designee may interfere with interpretation of ISRs
  • •Coagulopathy (primary or iatrogenic) which would contraindicate IM injection
  • •Active or planned use of prohibited medications as described in the IB or listed in the SSP Manual (provided by self\-report, or obtained from medical history or medical records)

Investigators

Sponsor
Division of HIV and AIDS

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