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MainTitle

Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men

This study is currently recruiting participants. (see Contacts and Locations)

Verified October 2017 by National Institute of Allergy and Infectious Diseases (NIAID)

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator
ViiV Healthcare
Gilead Sciences

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT02720094

First received: March 21, 2016
Last updated: October 2, 2017
Last Verified: October 2017
History of Changes
Purpose

Purpose

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).

Condition Intervention Phase
HIV Infections

Drug : Cabotegravir tablets
Drug : TDF/FTC tablets
Drug : TDF/FTC placebo tablets
Drug : CAB placebo tablets
Drug : CAB LA
Drug : Placebo for CAB LA
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures

  • Number of documented incident HIV infections in Steps 1 and 2 [ Time Frame: Measured through participant's last study visit, up to 4.5 years after study entry ]
  • Number of Grade 2 or higher clinical and laboratory adverse events [ Time Frame: Measured through participant's last study visit, up to 4.5 years after study entry ]
Secondary Outcome Measures:
  • Number of documented incident HIV infections in Step 2 [ Time Frame: Measured through participant's last study visit, up to 4.5 years after study entry ]
  • Number of documented incident HIV infections in Steps 1, 2, and 3 [ Time Frame: Measured through participant's last study visit, up to 4.5 years after study entry ]
  • Number of documented incident HIV infections in Step 3 [ Time Frame: Measured through participant's last study visit, up to 4.5 years after study entry ]
  • Number of documented incident HIV infections in Step 2 and 3 [ Time Frame: Measured through participant's last study visit, up to 4.5 years after study entry ]
  • Changes from baseline in creatinine and creatinine clearance levels [ Time Frame: Measured through participant's last study visit, up to 4.5 years after study entry ]
  • Number of Grade 3 or 4 liver-related adverse events (AEs) [ Time Frame: Measured through participant's last study visit, up to 4.5 years after study entry ]
    (laboratory assessment of alanine aminotransferase (ALT), aspartate aminotransferase (AST), TBili, creatine phosphokinase (CPK), or clinical assessment of jaundice/icterus).
  • Changes in Z-score from baseline and DXA criteria for osteopenia and osteoporosis [ Time Frame: Measured through participant's last study visit, up to 4.5 years after study entry ]
  • Incidence of resistance mutations to study products (including but not limited to K65R, M184V/I, Q148R) among seroconverters [ Time Frame: Measured through participant's last study visit, up to 4.5 years after study entry ]

Estimated Enrollment: 4500
Study Start Date: December 2016
Estimated Primary Completion Date: September 30, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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. In Step 3, participants will receive daily oral TDF/FTC no later than 8 weeks after the last injection, for up to 48 weeks.
Drug: Cabotegravir tablets

30 mg tablets

Drug: TDF/FTC tablets

300 mg/200 mg fixed-dose combination tablets

Drug: TDF/FTC placebo tablets
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

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. In Step 3, participants will receive daily oral TDF/FTC no later than 8 weeks after the last injection, for up to 48 weeks.
Drug: TDF/FTC tablets

300 mg/200 mg fixed-dose combination tablets

Drug: CAB placebo tablets
Drug: Placebo for CAB LA

Administered as one 3 mL (600 mg) injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

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 remain in the study between 1.5 years to 4.5 years, depending on when they enroll in the study.
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.
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.
In Step 3, all participants (Arms A and B) will receive daily oral TDF/FTC tablets no later than 8 weeks after the last injection, for up to 48 weeks.
Participants will attend up to 57 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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

Criteria

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
    • 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
  • 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).
  • 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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02720094

Locations

United States, Alabama
Alabama CRS Recruiting
Birmingham, Alabama, United States, 35294
Contact: Edgar T. Overton, M.D.    205-934-5191    eoverton@uabmc.edu
United States, California
UCLA Vine Street Clinic CRS Recruiting
Los Angeles, California, United States, 90024
Contact: Marisa Briones    310-461-3106    mbriones@mednet.ucla.edu
UCLA CARE Center CRS Recruiting
Los Angeles, California, United States, 90035
Contact: Arezou S. Akha, M.D., M.S.    310-557-3798    asadighi@mednet.ucla.edu
East Bay AIDS Center (EBAC) CRS Recruiting
Oakland, California, United States, 94609
Contact: Jamie Carroll-Mandelke, R.N.    510-869-8490    mandelj@sutterhealth.org
Bridge HIV CRS Recruiting
San Francisco, California, United States, 94143
Contact: Theresa M. Wagner, M.P.H.    415-437-7436    Theresa.Wagner@sfdph.org
United States, Colorado
Children's Hospital Colorado CRS Recruiting
Aurora, Colorado, United States, 80045
Contact: Emily Barr, C.P.N.P., C.N.M., M.S.N.    720-777-6752    emily.barr@childrenscolorado.org
United States, District of Columbia
George Washington Univ. CRS Recruiting
Washington, D.C., District of Columbia, United States, 20037-1894
Contact: Matt Levy, M.S.    202-350-0073    mattelevy@gwu.edu
United States, Florida
The University of Miami AIDS Clinical Research Unit (ACRU) CRS Recruiting
Miami, Florida, United States, 33136
Contact: Hancy Brignol, B.S.N., M.H.S.A.    305-243-3838    hbrignol@med.miami.edu
United States, Georgia
The Ponce de Leon Center CRS Recruiting
Atlanta, Georgia, United States, 30308-2012
Contact: Ericka Patrick, M.S.N.    404-616-6313    erpatri@emory.edu
The Hope Clinic of the Emory Vaccine Center CRS Recruiting
Decatur, Georgia, United States, 30030
Contact: Shashikala Nagar, B.Sc., M.P.H.    404-712-1370    shashi.nagar@emory.edu
United States, Illinois
Adolescent & Young Adult Research at The CORE Center (AYAR at CORE) Recruiting
Chicago, Illinois, United States, 60612
Contact: Kelly Bojan, R.N., C.F.N.P., A.P.N., D.N.P.    312-572-4571    kbojan@cookcountyhhs.org
UIC Project WISH CRS Recruiting
Chicago, Illinois, United States, 60612
Contact: Regina Harden, B.A    312-413-5897    ginaha@uic.edu
United States, Louisiana
New Orleans Adolescent Trials Unit CRS Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Leslie Kozina, R.N., C.C.R.C.    504-988-5348    lkozina@tulane.edu
United States, Maryland
Johns Hopkins University CRS Recruiting
Baltimore, Maryland, United States, 21205
Contact: Ilene Wiggins, R.N.    410-614-2766    iwiggin1@jhmi.edu
United States, Massachusetts
Fenway Health (FH) CRS Recruiting
Boston, Massachusetts, United States, 02215-4302
Contact: Marcy Gelman, R.N., M.S.N., M.P.H., A.R.N.P    617-927-6021    mgelman@fenwayhealth.org
United States, Missouri
Washington University Therapeutics (WT) CRS Recruiting
Saint Louis, Missouri, United States, 63110-1010
Contact: Michael K. Klebert    314-747-1098    mklebert@dom.wustl.edu
United States, New Jersey
New Jersey Medical School Clinical Research Center CRS Recruiting
Newark, New Jersey, United States, 07103
Contact: Baljinder Singh    973-972-3811    singhba@njms.rutgers.edu
United States, New York
Weill Cornell Chelsea CRS Recruiting
New York, New York, United States, 10010
Contact: Todd Stroberg, R.N., B.S.N.    212-746-7198    tstrober@med.cornell.edu
Harlem Prevention Center CRS Recruiting
New York, New York, United States, 10027
Contact: Avelino Loquere, R.N., CCRC, C.C.R.P.    646-448-0941    al2061@cumc.columbia.edu
New York Blood Center CRS Recruiting
New York, New York, United States, 10065
Contact: Debbie Lucy    212-388-0008    dlucy@nybc.org
Bronx Prevention Research Center CRS Recruiting
The Bronx, New York, United States, 10451
Contact: Rita Sondengam, M.P.H.    347-590-7280    RS2227@cumc.columbia.edu
United States, North Carolina
Chapel Hill CRS Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Susan Pedersen    919-966-6713    spederse@med.unc.edu
Greensboro CRS Recruiting
Greensboro, North Carolina, United States, 27401
Contact: Kim Epperson, R.N., B.S.N., CRC    336-832-3262    kim.epperson@conehealth.com
United States, Ohio
Cincinnati Clinical Research Site Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Sharon Kohrs, R.N., B.S.N.    513-584-6383    kohrssd@ucmail.uc.edu
Ohio State University CRS Recruiting
Columbus, Ohio, United States, 43210
Contact: Kathy Watson, B.S.N.    614-293-5856    kathy.watson@osumc.edu
United States, Pennsylvania
Penn Prevention CRS Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Debora Dunbar, M.S.N., C.R.N.P.    215-746-3713    ddunbar@mail.med.upenn.edu
United States, Tennessee
St. Jude Children's Research Hospital CRS Recruiting
Memphis, Tennessee, United States, 38105-3678
Contact: Sandra Jones, P.N.P.    901-595-5059    Sandra.Jones2@STJUDE.org
United States, Texas
Houston AIDS Research Team CRS Recruiting
Houston, Texas, United States, 77030
Contact: Maria L. Martinez    713-500-6718    Maria.L.Martinez@uth.tmc.edu
Argentina
Fundacion Huesped CRS Recruiting
Buenos Aires, Argentina, C1202ABB
Contact: Marcelo de las Heras, Ph.D.    54-11-49817777 ext 132    marcelo.delasheras@huesped.org.ar
Brazil
Hospital Nossa Senhora da Conceicao CRS Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
Contact: Rita d. Lira, M.D.    55-51-33572603    Lrita@ghc.com.br
Centro de Referencia e Treinamento DST/AIDS CRS Recruiting
São Paulo, Sao Paulo, Brazil, 04121-000
Contact: Priscilla de Lima e Menezes, R.N.    55-11-50840357    pmenezes@crt.saude.sp.gov.br
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS Recruiting
Rio de Janeiro, Brazil, 21040-360
Contact: Sandra W. Cardoso, Ph.D., M.D.    55-21-22707064    sandra.wagner@ipec.fiocruz.br
Centro de Pesquisas Clínicas IC-HCFMUSP CRS Recruiting
Sao Paulo, Brazil, 05403-000
Contact: Zelinda M. Nakagawa, M.Sc.    55-11-26613344    zelinda.bartolomei@gmail.com
Peru
CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales - Unidad de Ensayos Clínicos CRS Recruiting
Bellavista, Callao, Peru, 15081
Contact: Sara Tume    51-1-3736803    stume@citbm.pe
ACSA CRS Recruiting
Iquitos, Maynas, Peru, 1
Contact: Ana P. Quiroz    51-65-236277 ext 137    arimachi@acsaperu.org
Barranco CRS Recruiting
Lima, Peru, 04
Contact: Fanny Rosas, R.N.    51-1-2067800 ext 401    frosas@impactaperu.org
San Miguel CRS Recruiting
Lima, Peru, 32
Contact: Carla J. Porcile, R.N.    51-1-5621600 ext 644    cporcile@impactaperu.org
Via Libre CRS Recruiting
Lima, Peru
Contact: Fernando Roman    51-12-039900 ext 151    asistente.investigaciones.vl@gmail.com
South Africa
Groote Schuur HIV CRS Recruiting
Cape Town, Western Cape Province, South Africa, 7925
Contact: Christie Heiberg, B.Sc.    27-21-6503621    Christie.Heiberg@hiv-research.org.za
Thailand
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS Recruiting
Pathumwan, Bangkok, Thailand, 10330
Contact: Parawee Thongpaeng    662-6523040 ext 106    parawee.t@hivnat.org
Silom Community Clinic CRS Recruiting
Bangkok, Nonthaburi, Thailand, 11000
Contact: Chaiwat Ungsedhapand, M.D.    66-26-446290    yis1@cdc.gov
CMU HIV Prevention CRS Recruiting
Chiang Mai, Thailand, 50202
Contact: Pongpun Saokhieo, B.S.N., M.P.H.    66-5-3945055    pongpun@rihes.org
Vietnam
Yen Hoa Health Clinic CRS Recruiting
Hanoi, Vietnam, 100000
Contact: Tran Viet Ha    84-29-12785886    vietha@live.unc.edu

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
ViiV Healthcare
Gilead Sciences

Investigators

Study Chair: Raphael J. Landovitz, MD, MSc University of California, Los Angeles
More Information

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT02720094   History of Changes  
Other Study ID Numbers: HPTN 083  
  20725  
Study First Received: March 21, 2016  
Last Updated: October 2, 2017  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Pre-Exposure Prophylaxis
PrEP

Additional relevant MeSH terms:
HIV Infections
Tenofovir
Emtricitabine

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.