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HIV prevention breakthrough: a shot every two months could replace daily pills

NCT ID NCT02720094

Prevention Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This large study tested whether an injectable drug called cabotegravir, given every two months, could prevent HIV infection as well as or better than daily Truvada pills. It enrolled over 4,500 HIV-negative men and transgender women who have sex with men and are at high risk for HIV. The goal was to see if the shot is safe and effective for pre-exposure prophylaxis (PrEP).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cabotegravir (injectable)
What this could lead to
If it works, this could offer a long-acting injection every two months instead of daily pills for HIV prevention.
What could go wrong
This is a completed phase 2b/3 trial, but results may not apply to all populations. Side effects like injection site reactions or kidney issues are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

4,570 people

The number who actually took part.

Started

Dec 2016

Finished

Mar 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections

Contacts and locations

Locations

  • ACSA CRS

    Iquitos, Maynas, 1, Peru

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

    Chicago, Illinois, 60612, United States

  • Alabama CRS

    Birmingham, Alabama, 35294, United States

  • Barranco CRS

    Lima, 15063, Peru

  • Bridge HIV CRS

    San Francisco, California, 94143, United States

  • Bronx Prevention Research Center CRS

    The Bronx, New York, 10451, United States

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

    Bellavista, Provincia Constitucional del Callao, 15081, Peru

  • CMU HIV Prevention CRS

    Chiang Mai, 50202, Thailand

  • Centro de Pesquisas Clínicas IC-HCFMUSP CRS

    São Paulo, 05403-010, Brazil

  • Centro de Referencia e Treinamento DST/AIDS CRS

    São Paulo, São Paulo, 04121-000, Brazil

  • Chapel Hill CRS

    Chapel Hill, North Carolina, 27599, United States

  • Children's Hospital Colorado CRS

    Aurora, Colorado, 80045, United States

  • Cincinnati Clinical Research Site

    Cincinnati, Ohio, 45219, United States

  • East Bay AIDS Center (EBAC) CRS

    Oakland, California, 94609, United States

  • Fenway Health (FH) CRS

    Boston, Massachusetts, 02215-4302, United States

  • Fundacion Huesped CRS

    Buenos Aires, C1202ABB, Argentina

  • George Washington Univ. CRS

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

  • Greensboro CRS

    Greensboro, North Carolina, 27401, United States

  • Groote Schuur HIV CRS

    Cape Town, Western Cape, 7925, South Africa

  • Harlem Prevention Center CRS

    New York, New York, 10027, United States

  • Hospital General de Agudos JM Ramos Mejía CRS

    Ciudad de Buenos Aires, Buenos Aires, C1221ADC, Argentina

  • Hospital Nossa Senhora da Conceicao CRS

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Houston AIDS Research Team CRS

    Houston, Texas, 77030, United States

  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

    Rio de Janeiro, 21040-360, Brazil

  • Johns Hopkins University CRS

    Baltimore, Maryland, 21205, United States

  • New Jersey Medical School Clinical Research Center CRS

    Newark, New Jersey, 07103, United States

  • New Orleans Adolescent Trials Unit CRS

    New Orleans, Louisiana, 70112, United States

  • New York Blood Center CRS

    New York, New York, 10065, United States

  • Ohio State University CRS

    Columbus, Ohio, 43210, United States

  • Penn Prevention CRS

    Philadelphia, Pennsylvania, 19104, United States

  • San Miguel CRS

    Lima, 32 - 15088, Peru

  • Silom Community Clinic CRS

    Bangkok, Changwat Nonthaburi, 11000, Thailand

  • St. Jude Children's Research Hospital CRS

    Memphis, Tennessee, 38105-3678, United States

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

    Pathum Wan, Bangkok, 10330, Thailand

  • The Hope Clinic of the Emory Vaccine Center CRS

    Decatur, Georgia, 30030, United States

  • The Ponce de Leon Center CRS

    Atlanta, Georgia, 30308-2012, United States

  • UCLA CARE Center CRS

    Los Angeles, California, 90035, United States

  • UCLA Vine Street Clinic CRS

    Los Angeles, California, 90024, United States

  • UIC Project WISH CRS

    Chicago, Illinois, 60612, United States

  • Via Libre CRS

    Lima, 15001, Peru

  • Washington University Therapeutics (WT) CRS

    St Louis, Missouri, 63110-1010, United States

  • Weill Cornell Chelsea CRS

    New York, New York, 10010, United States

  • Yen Hoa Health Clinic CRS

    Hanoi, 100000, Vietnam

More trials for these conditions

Other studies related to the condition(s) this trial covers.