Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men
NCT ID: NCT02720094
Last Updated: 2025-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
4570 participants
INTERVENTIONAL
2016-12-19
2025-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
Cabotegravir Oral Tablet
30 mg tablet
TDF/FTC tablets
300 mg/200 mg fixed-dose combination tablets
Placebo for TDF/FTC tablets
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
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.
TDF/FTC tablets
300 mg/200 mg fixed-dose combination tablets
Placebo for cabotegravir oral tablet
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
Interventions
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Cabotegravir Oral Tablet
30 mg tablet
TDF/FTC tablets
300 mg/200 mg fixed-dose combination tablets
Placebo for TDF/FTC tablets
Placebo for cabotegravir oral tablet
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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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ViiV Healthcare
INDUSTRY
Gilead Sciences
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Raphael J. Landovitz, MD, MSc
Role: STUDY_CHAIR
University of California, Los Angeles
Locations
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Alabama CRS
Birmingham, Alabama, United States
UCLA Vine Street Clinic CRS
Los Angeles, California, United States
UCLA CARE Center CRS
Los Angeles, California, United States
East Bay AIDS Center (EBAC) CRS
Oakland, California, United States
Bridge HIV CRS
San Francisco, California, United States
Children's Hospital Colorado CRS
Aurora, Colorado, United States
George Washington Univ. CRS
Washington D.C., District of Columbia, United States
The Ponce de Leon Center CRS
Atlanta, Georgia, United States
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, United States
Adolescent & Young Adult Research at The CORE Center (AYAR at CORE)
Chicago, Illinois, United States
UIC Project WISH CRS
Chicago, Illinois, United States
New Orleans Adolescent Trials Unit CRS
New Orleans, Louisiana, United States
Johns Hopkins University CRS
Baltimore, Maryland, United States
Fenway Health (FH) CRS
Boston, Massachusetts, United States
Washington University Therapeutics (WT) CRS
St Louis, Missouri, United States
New Jersey Medical School Clinical Research Center CRS
Newark, New Jersey, United States
Weill Cornell Chelsea CRS
New York, New York, United States
Harlem Prevention Center CRS
New York, New York, United States
New York Blood Center CRS
New York, New York, United States
Bronx Prevention Research Center CRS
The Bronx, New York, United States
Chapel Hill CRS
Chapel Hill, North Carolina, United States
Greensboro CRS
Greensboro, North Carolina, United States
Cincinnati Clinical Research Site
Cincinnati, Ohio, United States
Ohio State University CRS
Columbus, Ohio, United States
Penn Prevention CRS
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital CRS
Memphis, Tennessee, United States
Houston AIDS Research Team CRS
Houston, Texas, United States
Hospital General de Agudos JM Ramos Mejía CRS
Ciudad de Buenos Aires, Buenos Aires, Argentina
Fundacion Huesped CRS
Buenos Aires, , Argentina
Hospital Nossa Senhora da Conceicao CRS
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Referencia e Treinamento DST/AIDS CRS
São Paulo, São Paulo, Brazil
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, , Brazil
Centro de Pesquisas Clínicas IC-HCFMUSP CRS
São Paulo, , Brazil
ACSA CRS
Iquitos, Maynas, Peru
CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS
Bellavista, Provincia Constitucional del Callao, Peru
Via Libre CRS
Lima, , Peru
Barranco CRS
Lima, , Peru
San Miguel CRS
Lima, , Peru
Groote Schuur HIV CRS
Cape Town, Western Cape, South Africa
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
Pathum Wan, Bangkok, Thailand
Silom Community Clinic CRS
Bangkok, Changwat Nonthaburi, Thailand
CMU HIV Prevention CRS
Chiang Mai, , Thailand
Yen Hoa Health Clinic CRS
Hanoi, , Vietnam
Countries
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References
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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 Jul 1:ciaf221. doi: 10.1093/cid/ciaf221. Online ahead of print.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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20725
Identifier Type: REGISTRY
Identifier Source: secondary_id
HPTN 083
Identifier Type: -
Identifier Source: org_study_id
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