Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men

A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine For Pre-Exposure Prophylaxis in HIV-Uninfected Men and Transgender Women Who Have Sex With Men

This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: CAB LA; Drug: Cabotegravir Oral Tablet; Drug: TDF/FTC tablets; Drug: Placebo for TDF/FTC tablets; Drug: Placebo for cabotegravir oral tablet; Drug: Placebo for CAB LA

Detailed Description

The purpose of this study is to evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).

This study will enroll HIV-uninfected MSM and TGW at risk for acquiring HIV infection. Participants will be followed for a total of 4 years.

This study will take place in three steps. Participants will be randomly assigned to one of two arms:

Arm A:

Step 1: Participants will receive daily oral CAB tablets and daily oral TDF/FTC placebo tablets for 5 weeks.

Step 2: Participants will receive an intramuscular (IM) injection of CAB LA at two time points 4 weeks apart and every 8 weeks thereafter and daily oral TDF/FTC placebo tablets to Week 153.

Arm B:

Step 1: Participants will receive daily oral TDF/FTC tablets and daily oral CAB placebo tablets for 5 weeks.

Step 2: Participants will receive daily oral TDF/FTC tablets and an IM injection of placebo at two time points 4 weeks apart and every 8 weeks thereafter to Week 153.

In Step 3, all participants (Arms A and B) will receive daily oral TDF/FTC tablets starting at Week 153 (last day of Step 2)/Day 0 (first day of Step 3) and continue for 48 weeks.

Participants will attend up to 47 study visits throughout the study. Visits may include physical examinations, blood collection, urine collection, an electrocardiogram (ECG), and rectal swab collection. Some participants may have a bone mineral density-energy x-ray absorptimetry (DXA) scan at select visits.

All participants will be transitioned to locally available HIV prevention services, including services for PrEP, if available, at the end of their participation in the study.

HPTN 083-01 is a sub-study of HPTN 083. The purpose of this study is to evaluate the safety, tolerability, and acceptability of CAB LA for the prevention of HIV among adolescent males. Participants will receive oral CAB for 5 weeks, followed by 29 weeks on CAB LA, then quarterly visits for 48 weeks after final injection. All participants who have received at least one injection will be followed for 48 weeks after their last injection. Total study duration per participant will be approximately 21 months.

HPTN 083-02 is a qualitative sub-study of participants enrolled in HPTN 083. The purpose of this study is to explore potential barriers, facilitators, and potentially modifiable issues related to adherence to clinic visits in the context of injectable PrEP; to learn about preferences and decision making regarding the use of oral versus injectable PrEP, or other biomedical prevention products; and to gather explanatory qualitative data regarding participants' experiences in HPTN 083 to better interpret study results and guide next prevention strategies. Participants in this sub-study will complete one individual semi-structured qualitative interview.

• Study Type: Interventional
• Enrollment (Actual): 4570
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1202ABB
    • Fundacion Huesped CRS
  • Buenos Aires
    • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1221ADC
      • Hospital General de Agudos JM Ramos Mejía CRS
• Brazil
  • Rio de Janeiro, Brazil, 21040-360
    • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
  • São Paulo, Brazil, 05403-010
    • Centro de Pesquisas Clínicas IC-HCFMUSP CRS
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Hospital Nossa Senhora da Conceicao CRS
  • São Paulo
    • São Paulo, São Paulo, Brazil, 04121-000
      • Centro de Referencia e Treinamento DST/AIDS CRS
• Peru
  • Lima, Peru, 15063
    • Barranco CRS
  • Lima, Peru, 32 - 15088
    • San Miguel CRS
  • Lima, Peru, 15001
    • Via Libre CRS
  • Maynas
    • Iquitos, Maynas, Peru, 1
      • ACSA CRS
  • Provincia Constitucional del Callao
    • Bellavista, Provincia Constitucional del Callao, Peru, 15081
      • CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS
• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7925
      • Groote Schuur HIV CRS
• Thailand
  • Chiang Mai, Thailand, 50202
    • CMU HIV Prevention CRS
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
  • Changwat Nonthaburi
    • Bangkok, Changwat Nonthaburi, Thailand, 11000
      • Silom Community Clinic CRS
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Alabama CRS
  • California
    • Los Angeles, California, United States, 90035
      • UCLA CARE Center CRS
    • Los Angeles, California, United States, 90024
      • UCLA Vine Street Clinic CRS
    • Oakland, California, United States, 94609
      • East Bay AIDS Center (EBAC) CRS
    • San Francisco, California, United States, 94143
      • Bridge HIV CRS
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado CRS
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037-1894
      • George Washington Univ. CRS
  • Georgia
    • Atlanta, Georgia, United States, 30308-2012
      • The Ponce de Leon Center CRS
    • Decatur, Georgia, United States, 30030
      • The Hope Clinic of the Emory Vaccine Center CRS
  • Illinois
    • Chicago, Illinois, United States, 60612
      • UIC Project WISH CRS
    • Chicago, Illinois, United States, 60612
      • Adolescent & Young Adult Research at The CORE Center (AYAR at CORE)
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • New Orleans Adolescent Trials Unit CRS
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University CRS
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-4302
      • Fenway Health (FH) CRS
  • Missouri
    • St Louis, Missouri, United States, 63110-1010
      • Washington University Therapeutics (WT) CRS
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • New Jersey Medical School Clinical Research Center CRS
  • New York
    • New York, New York, United States, 10027
      • Harlem Prevention Center CRS
    • New York, New York, United States, 10065
      • New York Blood Center CRS
    • New York, New York, United States, 10010
      • Weill Cornell Chelsea CRS
    • The Bronx, New York, United States, 10451
      • Bronx Prevention Research Center CRS
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Chapel Hill CRS
    • Greensboro, North Carolina, United States, 27401
      • Greensboro CRS
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Cincinnati Clinical Research Site
    • Columbus, Ohio, United States, 43210
      • Ohio State University CRS
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Prevention CRS
  • Tennessee
    • Memphis, Tennessee, United States, 38105-3678
      • St. Jude Children's Research Hospital CRS
  • Texas
    • Houston, Texas, United States, 77030
      • Houston AIDS Research Team CRS
• Vietnam
  • Hanoi, Vietnam, 100000
    • Yen Hoa Health Clinic CRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• MSM and TGW, 18 years or older at the time of screening (male at birth)
• Willing to provide informed consent for the study

• At high risk for sexually acquiring HIV infection based on self-report of at least one of the following:

  • Any condomless receptive anal intercourse in the 6 months prior to enrollment (condomless anal intercourse within a monogamous HIV seronegative concordant relationship does not meet this criterion)
  • More than five partners in the 6 months prior to enrollment (regardless of condom use and HIV serostatus, as reported by the enrollee)
  • Any stimulant drug use in the 6 months prior to enrollment
  • Rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to enrollment
  • SexPro score of less than or equal to 16 (U.S. sites only)

• In general good health, as evidenced by the following laboratory values, which must be from specimens obtained within 45 days prior to study enrollment:

  • Non-reactive / negative HIV test results. More information on this criterion can be found in the protocol.
  • Hemoglobin greater than 11 g/dL,
  • Absolute neutrophil count greater than 750 cells/mm^3
  • Platelet count greater than or equal to 100,000/mm^3

  • Calculated creatinine clearance greater than or equal to 60 mL/minute using the 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
  • Alanine aminotransferase (ALT) less than 2 times the upper limit of normal (ULN)
  • Total bilirubin less than or equal to 2.5 times ULN
  • Hepatitis B virus (HBV) surface antigen (HBsAg) negative
  • Hepatitis C virus (HCV) Ab negative
  • No Grade 3 or higher laboratory abnormalities on any laboratory tests obtained at screening, including tests obtained as part of a panel of tests ordered to obtain the protocol-required laboratory test results.
• No medical condition that, in the opinion of the study investigator, would interfere with the conduct of the study (e.g., provided by self-report, or found upon medical history and examination or in available medical records)
• Willing to undergo all required study procedures

Exclusion Criteria:

• One or more reactive or positive HIV test result at Screening or Enrollment, even if HIV infection is not confirmed
• Active or recent use of any illicit intravenous drugs ("recent" defined as in the 90 days prior to enrollment)
• Co-enrollment in any other interventional research study or other concurrent studies that may interfere with this study (as provided by self-report or other available documentation. Exceptions may be made if appropriate after consultation with the CMC.)
• Past or current participation in HIV vaccine trial. An exception will be made for participants that can provide documentation of receipt of placebo (not active arm). Note: Past participation in a monoclonal antibody study is not exclusionary, effective as of Version 1.0 of HPTN 083.
• 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 intramuscular (IM) injections, per the discretion of the Investigator of Record. Mild skin conditions may not be exclusionary at the discretion of the Investigator of Record (IoR) or designee in consultation with the CMC
• Has a tattoo or other dermatological condition overlying the buttock region which in the opinion of the IoR or designee, in consultation with the CMC, may interfere with interpretation of injection site reactions
• 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)
• Coagulopathy (primary or iatrogenic) which would contraindicate IM injection (concomitant anticoagulant or anti-platelet therapy use should be discussed with the CMC)
• Active or planned use of prohibited medications as described in the Investigator's Brochure or listed in the Study Specific Procedures (SSP) Manual (provided by self-report, or obtained from medical history or medical records). In particular, future use of TDF/FTC at any point during the study.
• Known or suspected allergy to study product components (active or placebo), including egg or soy products (egg and soy products are contained in Intralipid)
• Surgically-placed or injected buttock implants or fillers, per self-report. Contact the CMC for guidance regarding questions about individual cases.
• Alcohol or substance use that, in the opinion of the study investigator, would jeopardize the safety of the participant on study (e.g., provided by self-report, or found upon medical history and examination or in available medical records).
• History of seizure disorder, per self-report
• QTc interval (B or F) greater than 500 msec

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.	Drug: CAB LA; Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter; Other Names: Long acting cabotegravir; Injectable cabotegravir; Drug: Cabotegravir Oral Tablet; 30 mg tablet; Other Names: Oral cabotegravir; Drug: TDF/FTC tablets; 300 mg/200 mg fixed-dose combination tablets; Other Names: Truvada; Drug: Placebo for TDF/FTC tablets; Other Names: Placebo for Truvada
Experimental: Arm B; In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.	Drug: TDF/FTC tablets; 300 mg/200 mg fixed-dose combination tablets; Other Names: Truvada; Drug: Placebo for cabotegravir oral tablet; Other Names: Placebo for oral cabotegravir; Drug: Placebo for CAB LA; Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter; Other Names: Placebo for long acting cabotegravir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Documented Incident HIV Infections During Steps 1 and 2	All HIV infections included in this analysis have been reviewed and confirmed by an independent, blinded Endpoint Adjudication Committee (EAC).	HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.
Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events	The primary safety endpoint analyses included Grade 2 or higher clinical and laboratory AEs during Steps 1 and 2.	Treatment emergent AE* measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes From Baseline in Creatinine and Creatinine Clearance Levels	Change from baseline at each visit is the difference between the creatine (and creatinine clearance) value as measured on the date of visit, compared to the value as measured at the enrollment visit.	Reported week 57 (injection visit #8) and week 105 (injection visit #14)
Number of Participants With Grade 3 or 4 Liver-related Adverse Events (AEs)	Laboratory assessment of alanine aminotransferase (ALT), aspartate aminotransferase (AST), TBili, creatine phosphokinase (CPK), or clinical assessment of jaundice/icterus.	Treatment emergent AE measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is first. Assessed at each visit. (Injection visits q 8 weeks and safety visits q 8 weeks)
Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters	Frequency of the detection of specific viral mutations known to confer resistance to specific classes of antiviral drugs as identified in specimens collected from infected participants during follow-up after HIV infection.	Measured from date of detection of infection, up to 4 years after study entry, with timing/intervals as determined by the HPTN laboratory center
Changes in Weight From Baseline	Change in weight from baseline is the difference between the weight (kg) as collected at each study visit and the weight collected at the enrollment visit.	Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Collected at each injection visit (every 8 weeks).
Changes in Pulse Rate From Baseline	Change in pulse rate from baseline is the difference between the pulse rate as collected at each study visit and the pulse rate collected at the enrollment visit.	Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).
Changes in Fasting Glucose Levels From Baseline	Changes in fasting glucose levels from baseline at week 57 and week 105 based on laboratory evaluations.	Assessed at weeks 57 and 105.
Changes in Fasting Lipid Profile From Baseline	Changes in fasting lipid profile from baseline at week 57 and week 105 based on laboratory evaluations.	Assessed at weeks 57 and 105.
Number of Participants With Documented Incident HIV Infections in Step 2	Evaluate incident HIV-1infections occurring only during Step 2, using the Injection Step 2 Efficacy population	HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.
Changes in Systolic Blood Pressure From Baseline	Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole.	Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).
Changes in Diastolic Blood Pressure From Baseline	Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole.	Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).
Summary of Overall Satisfaction With Study Product	Summary of overall satisfaction with study product at Week 17 and Week 41. 0 represents None of the time and 6 represents All of the times for the questions 'How often is it inconvenient or difficult to receive oral study medication as recommended?' and 'How often do you find it inconvenient or difficult to receive your injection as recommended?', 0 represents None at all and 6 represent A very great deal for the questions 'How much pain or discomfort have you experienced with your oral study medication (tablets)?' and 'How much pain or discomfort have you experienced with your injection?'.	Assessed at Week 17, 41
Summary of Preference Based on Satisfaction With Study Product	Summary of preference based on satisfaction with study product at Week 17 and Week 41	Assessed at week 17, 41
Change From Baseline of Mean Z-scores of Bone Mineral Density	Change from baseline of mean standard scores (Z-scores) to week 57 and week 105 in the bone mineral density (BMD) at femoral neck, lumbar spine, and total hip region were summarized using DEXA subset. BMD z-scores from Hologic instrument scans were standardized by race, age, and gender using the Hologic DXA Reference Data. Male reference values were used for men who have sex with men and female reference values for transgender women. A z-score of 0 represents the mean of the analysis population standardized by race, age, and gender. Higher z-scores in BMD indicate a better outcomes. A z-score of -2.0 or lower is generally considered below the expected range, potentially indicating secondary osteoporosis requiring further medical evaluation.	Measured at enrollment, week 57 and week 105

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Gilead Sciences; ViiV Healthcare
• Investigators: Study Chair: Raphael J. Landovitz, MD, MSc, University of California, Los Angeles

Publications and helpful links

General Publications

• Landovitz RJ, Donnell D, Clement ME, Hanscom B, Cottle L, Coelho L, Cabello R, Chariyalertsak S, Dunne EF, Frank I, Gallardo-Cartagena JA, Gaur AH, Gonzales P, Tran HV, Hinojosa JC, Kallas EG, Kelley CF, Losso MH, Madruga JV, Middelkoop K, Phanuphak N, Santos B, Sued O, Valencia Huamani J, Overton ET, Swaminathan S, Del Rio C, Gulick RM, Richardson P, Sullivan P, Piwowar-Manning E, Marzinke M, Hendrix C, Li M, Wang Z, Marrazzo J, Daar E, Asmelash A, Brown TT, Anderson P, Eshleman SH, Bryan M, Blanchette C, Lucas J, Psaros C, Safren S, Sugarman J, Scott H, Eron JJ, Fields SD, Sista ND, Gomez-Feliciano K, Jennings A, Kofron RM, Holtz TH, Shin K, Rooney JF, Smith KY, Spreen W, Margolis D, Rinehart A, Adeyeye A, Cohen MS, McCauley M, Grinsztejn B; HPTN 083 Study Team. Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women. N Engl J Med. 2021 Aug 12;385(7):595-608. doi: 10.1056/NEJMoa2101016.
• Scarsi KK. Chasing the cabotegravir tail: implications for prevention. Lancet HIV. 2020 Jul;7(7):e451-e453. doi: 10.1016/S2352-3018(20)30165-X. Epub 2020 Jun 1. No abstract available.
• Psaros C, Goodman GR, Lee JS, Rice W, Kelley CF, Oyedele T, Coelho LE, Phanuphak N, Singh Y, Middelkoop K, Griffith S, McCauley M, Rooney J, Rinehart AR, Clark J, Go V, Sugarman J, Fields SD, Adeyeye A, Grinsztejn B, Landovitz RJ, Safren SA; HPTN 083-02 Study Team. HPTN 083-02: factors influencing adherence to injectable PrEP and retention in an injectable PrEP study. J Int AIDS Soc. 2024 May;27(5):e26252. doi: 10.1002/jia2.26252.
• Han K, Patel P, McCallister S, Rinehart AR, Gandhi Y, Spreen W, Landovitz RJ, Delany-Moretlwe S, Marzinke MA, McKeon T, Budnik P, van Wyk J, Ford SL. Long-acting cabotegravir pharmacokinetics with and without oral lead-in for HIV PrEP. Antimicrob Agents Chemother. 2024 Jun 5;68(6):e0147523. doi: 10.1128/aac.01475-23. Epub 2024 May 6.
• Landovitz RJ, Hanscom BS, Clement ME, Tran HV, Kallas EG, Magnus M, Sued O, Sanchez J, Scott H, Eron JJ, Del Rio C, Fields SD, Marzinke MA, Eshleman SH, Donnell D, Spinelli MA, Kofron RM, Berman R, Piwowar-Manning EM, Richardson PA, Sullivan PA, Lucas JP, Anderson PL, Hendrix CW, Adeyeye A, Rooney JF, Rinehart AR, Cohen MS, McCauley M, Grinsztejn B; HPTN 083 Study Team. Efficacy and safety of long-acting cabotegravir compared with daily oral tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection in cisgender men and transgender women who have sex with men 1 year after study unblinding: a secondary analysis of the phase 2b and 3 HPTN 083 randomised controlled trial. Lancet HIV. 2023 Dec;10(12):e767-e778. doi: 10.1016/S2352-3018(23)00261-8. Epub 2023 Nov 9.
• Marzinke MA, Hanscom B, Wang Z, Safren SA, Psaros C, Donnell D, Richardson PA, Sullivan P, Eshleman SH, Jennings A, Feliciano KG, Jalil E, Coutinho C, Cardozo N, Maia B, Khan T, Singh Y, Middelkoop K, Franks J, Valencia J, Sanchez N, Lucas J, Rooney JF, Rinehart AR, Ford S, Adeyeye A, Cohen MS, McCauley M, Landovitz RJ, Grinsztejn B; HPTN 083 study group. Efficacy, safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis in transgender women: a secondary analysis of the HPTN 083 trial. Lancet HIV. 2023 Nov;10(11):e703-e712. doi: 10.1016/S2352-3018(23)00200-X. Epub 2023 Sep 29.
• Brown TT, Arao RF, Warsi M, Phanuphak N, Vasconcelos R, Oyedele T, Sullivan PA, Hanscom B, Rooney JF, Rinehart AR, McCauley M, Grinsztejn B, Landovitz RJ. Bone Changes With Long-Acting Cabotegravir or Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Prevention in Cisgender Men and Transgender Women: HPTN 083. Clin Infect Dis. 2025 Dec 24;81(5):983-986. doi: 10.1093/cid/ciaf221.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2016
• Primary Completion (Actual): May 14, 2020
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimated): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PrEP; Pre-Exposure Prophylaxis
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Nucleic Acids, Nucleotides, and Nucleosides; Purines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Organophosphorus Compounds; Nucleosides; Deoxyribonucleosides; Organophosphonates; Adenine; Drug Combinations; Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; cabotegravir
• Other Study ID Numbers: HPTN 083; 20725 (DAIDS ES)