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HIV InfectionsPhase 2/3NCT02720094

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

A Phase 2/3 study testing Cabotegravir Oral Tablet, TDF/FTC tablets and CAB LA in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 43 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
Cabotegravir Oral Tablet, TDF/FTC tablets and CAB LA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,570 participants
Where
43 sitesin 7 countries
Study dates
19 Dec 2016to 31 Mar 2025
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 22Show fewer
  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

43 sites in 7 countries.

43 sites in 7 countries

United States27 sites

  • The Ponce de Leon Center CRS

    Atlanta, Georgia, 30308-2012

  • Children's Hospital Colorado CRS

    Aurora, Colorado, 80045

  • Johns Hopkins University CRS

    Baltimore, Maryland, 21205

  • Alabama CRS

    Birmingham, Alabama, 35294

  • Fenway Health (FH) CRS

    Boston, Massachusetts, 02215-4302

  • Chapel Hill CRS

    Chapel Hill, North Carolina, 27599

  • Adolescent & Young Adult Research at The CORE Center (AYAR at CORE)

    Chicago, Illinois, 60612

  • UIC Project WISH CRS

    Chicago, Illinois, 60612

  • Cincinnati Clinical Research Site

    Cincinnati, Ohio, 45219

  • Ohio State University CRS

    Columbus, Ohio, 43210

  • The Hope Clinic of the Emory Vaccine Center CRS

    Decatur, Georgia, 30030

  • Greensboro CRS

    Greensboro, North Carolina, 27401

  • Houston AIDS Research Team CRS

    Houston, Texas, 77030

  • UCLA Vine Street Clinic CRS

    Los Angeles, California, 90024

  • UCLA CARE Center CRS

    Los Angeles, California, 90035

  • St. Jude Children's Research Hospital CRS

    Memphis, Tennessee, 38105-3678

  • New Orleans Adolescent Trials Unit CRS

    New Orleans, Louisiana, 70112

  • Weill Cornell Chelsea CRS

    New York, New York, 10010

  • Harlem Prevention Center CRS

    New York, New York, 10027

  • New York Blood Center CRS

    New York, New York, 10065

  • New Jersey Medical School Clinical Research Center CRS

    Newark, New Jersey, 07103

  • East Bay AIDS Center (EBAC) CRS

    Oakland, California, 94609

  • Penn Prevention CRS

    Philadelphia, Pennsylvania, 19104

  • Bridge HIV CRS

    San Francisco, California, 94143

  • Washington University Therapeutics (WT) CRS

    St Louis, Missouri, 63110-1010

  • Bronx Prevention Research Center CRS

    The Bronx, New York, 10451

  • George Washington Univ. CRS

    Washington D.C., District of Columbia, 20037-1894

Other trials in United States

Peru5 sites

  • CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS

    Bellavista, Provincia Constitucional del Callao, 15081

  • ACSA CRS

    Iquitos, Maynas, 1

  • Via Libre CRS

    Lima, 15001

  • Barranco CRS

    Lima, 15063

  • San Miguel CRS

    Lima, 32 - 15088

Other trials in Peru

Brazil4 sites

  • Hospital Nossa Senhora da Conceicao CRS

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

    Rio de Janeiro, 21040-360

  • Centro de Referencia e Treinamento DST/AIDS CRS

    São Paulo, São Paulo, 04121-000

  • Centro de Pesquisas Clínicas IC-HCFMUSP CRS

    São Paulo, 05403-010

Other trials in Brazil

Thailand3 sites

  • Silom Community Clinic CRS

    Bangkok, Changwat Nonthaburi, 11000

  • CMU HIV Prevention CRS

    Chiang Mai, 50202

  • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS

    Pathum Wan, Bangkok, 10330

Other trials in Thailand

Argentina2 sites

  • Fundacion Huesped CRS

    Buenos Aires, C1202ABB

  • Hospital General de Agudos JM Ramos Mejía CRS

    Ciudad de Buenos Aires, Buenos Aires, C1221ADC

Other trials in Argentina

South Africa1 site

  • Groote Schuur HIV CRS

    Cape Town, Western Cape, 7925

Other trials in South Africa

Vietnam1 site

  • Yen Hoa Health Clinic CRS

    Hanoi, 100000

Other trials in Vietnam

About this study

Official title: 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).

Read the 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.

Conditions
HIV Infections
Being tested
Cabotegravir Oral Tablet, TDF/FTC tablets, Placebo for TDF/FTC tablets, Placebo for cabotegravir oral tablet, CAB LA
Keywords
Pre-Exposure Prophylaxis, PrEP
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cabotegravir Oral TabletDrug

    Also called Oral cabotegravir

    30 mg tablet

  • TDF/FTC tabletsDrug

    Also called Truvada

    300 mg/200 mg fixed-dose combination tablets

  • Placebo for TDF/FTC tabletsDrug

    Also called Placebo for Truvada

  • Placebo for cabotegravir oral tabletDrug

    Also called Placebo for oral cabotegravir

  • CAB LADrug

    Also called Long acting cabotegravir, Injectable cabotegravir

    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 LADrug

    Also called Placebo for long acting cabotegravir

    Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Study groups in NCT02720094
Study groupRoleWhat they receive
Arm AExperimentalIn 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.
Receives: Drug: Cabotegravir Oral Tablet; Drug: TDF/FTC tablets; Drug: Placebo for TDF/FTC tablets; Drug: CAB LA
Arm BExperimentalIn 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.
Receives: Drug: TDF/FTC tablets; Drug: Placebo for cabotegravir oral tablet; Drug: Placebo for CAB LA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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.

  2. 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.

    Measured: 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 outcomes (13)

  1. 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

    Measured: 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.

  2. 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.

    Measured: Reported week 57 (injection visit #8) and week 105 (injection visit #14)

  3. 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.

    Measured: 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)

  4. 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: Measured from date of detection of infection, up to 4 years after study entry, with timing/intervals as determined by the HPTN laboratory center

  5. 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.

    Measured: 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).

  6. 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.

    Measured: 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).

  7. 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.

    Measured: 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).

  8. 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.

    Measured: 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).

  9. Changes in Fasting Glucose Levels From Baseline

    Changes in fasting glucose levels from baseline at week 57 and week 105 based on laboratory evaluations.

    Measured: Assessed at weeks 57 and 105.

  10. Changes in Fasting Lipid Profile From Baseline

    Changes in fasting lipid profile from baseline at week 57 and week 105 based on laboratory evaluations.

    Measured: Assessed at weeks 57 and 105.

  11. 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?'.

    Measured: Assessed at Week 17, 41

  12. Summary of Preference Based on Satisfaction With Study Product

    Summary of preference based on satisfaction with study product at Week 17 and Week 41

    Measured: Assessed at week 17, 41

  13. 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: Measured at enrollment, week 57 and week 105

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2016 (estimated)
  2. Study start19 Dec 2016
  3. Primary completion14 May 2020
  4. Study completion31 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,570 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02720094
Sponsor's protocol ID
HPTN 083
Other IDs
20725
Status last verified
Mar 2026
First submitted
21 Mar 2016
Last updated
19 Mar 2026
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 40590452

  • 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.

    PubMed 38783534

  • 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.

    PubMed 38709006

  • 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.

    PubMed 37952550

  • 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.

    PubMed 37783219

  • 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.

    PubMed 34379922

  • 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.

    PubMed 32497490

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cabotegravir Oral Tablet, TDF/FTC tablets and CAB LA in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 43 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Peru, Brazil, Thailand, Argentina and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Documented Incident HIV Infections During Steps 1 and 2 (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02720094, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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