Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    A5359
Previous Study | Return to List | Next Study

The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03635788
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
ViiV
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
The purpose of this study is to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC).

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Standard of Care (SOC) Oral ART Drug: Oral RPV Drug: Oral CAB Drug: RPV-LA Loading Dose Drug: CAB-LA Loading Dose Drug: RPV-LA Maintenance Dose Drug: CAB-LA Maintenance Dose Phase 3

Detailed Description:

This study will compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) with rilpivirine (RPV) LA and cabotegravir (CAB) LA versus all-oral standard of care (SOC).

The study includes four steps. In Step 1, participants will receive a SOC oral induction regimen consisting of an ART regimen that involves at least 3 drugs for 24 weeks. Participants who achieve milestones will receive conditional economic incentives at Weeks 2, 4, 8, 12, 16, and 20.

In Step 2, eligible participants will be randomized to receive either oral RPV + oral CAB for 4 weeks followed by RPV-LA + CAB-LA every 4 weeks for 48 weeks or to continue on SOC for 52 weeks.

At the completion of Step 2, eligible participants randomized to SOC will have the option to register to Step 3 and receive LA ART, which includes oral RPV + oral CAB for 4 weeks followed by RPV-LA + CAB-LA every 4 weeks for 48 weeks. Participants already receiving RPV-LA + CAB-LA in Step 2 will continue on this regimen in Step 3 for 52 weeks.

Eligible participants will enter Step 4 and be followed for 52 weeks on locally sourced oral ART.

Participants will be followed for up to a total of 180 weeks. Study visits, which will occur throughout the study, may include physical examinations; blood, urine, and hair collection; liver function tests; questionnaires; and an electrocardiogram (ECG).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-Adherent HIV-Infected Individuals
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 26, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Arm A: LA ART
In Step 1, participants will receive SOC oral ART regimen for 24 weeks. In Step 2, participants will receive oral RPV once daily and oral CAB once daily for 4 weeks, followed by a RPV-LA loading dose and a CAB-LA loading dose, followed in 4 weeks by a RPV-LA maintenance dose and a CAB-LA maintenance dose every 4 weeks for 44 weeks. In Step 3, participants will receive a RPV-LA maintenance dose and a CAB-LA maintenance dose every 4 weeks for 52 weeks. In Step 4, eligible participants will be followed until they complete 52 weeks on locally sourced oral ART.
Drug: Standard of Care (SOC) Oral ART
SOC oral ART regimen must include at least 3 drugs with 2 or more drugs predicted to be fully active, including a boosted protease inhibitor (PI) and/or an integrase strand transfer inhibitor (INSTI)

Drug: Oral RPV
RPV 25 mg tablets
Other Name: Rilpivirine

Drug: Oral CAB
CAB 30 mg tablets
Other Names:
  • Cabotegravir
  • GSK1265744

Drug: RPV-LA Loading Dose
900 mg administered as one 3 mL (900 mg) intramuscular injection in the gluteal muscle
Other Name: Rilpivirine Long-Acting Injectable

Drug: CAB-LA Loading Dose
600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle
Other Name: Cabotegravir Long-Acting Injectable

Drug: RPV-LA Maintenance Dose
600 mg administered as one 2 mL (600 mg) intramuscular injection in the gluteal muscle
Other Name: Rilpivirine Long-Acting Injectable

Drug: CAB-LA Maintenance Dose
400 mg administered as one 2 mL (400 mg) intramuscular injection in the gluteal muscle
Other Name: Cabotegravir Long-Acting Injectable

Active Comparator: Arm B: SOC Oral ART
In Step 1, participants will receive SOC oral ART regimen for 24 weeks. In Step 2, participants will continue SOC oral ART regimen for 52 weeks. In Step 3, participants will receive oral RPV once daily and oral CAB once daily for 4 weeks, followed by a RPV-LA loading dose and a CAB-LA loading dose, followed in 4 weeks by a RPV-LA maintenance dose and CAB-LA maintenance dose every 4 weeks for 44 weeks. In Step 4, eligible participants will be followed until they complete 52 weeks on locally sourced oral ART.
Drug: Standard of Care (SOC) Oral ART
SOC oral ART regimen must include at least 3 drugs with 2 or more drugs predicted to be fully active, including a boosted protease inhibitor (PI) and/or an integrase strand transfer inhibitor (INSTI)

Drug: Oral RPV
RPV 25 mg tablets
Other Name: Rilpivirine

Drug: Oral CAB
CAB 30 mg tablets
Other Names:
  • Cabotegravir
  • GSK1265744

Drug: RPV-LA Loading Dose
900 mg administered as one 3 mL (900 mg) intramuscular injection in the gluteal muscle
Other Name: Rilpivirine Long-Acting Injectable

Drug: CAB-LA Loading Dose
600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle
Other Name: Cabotegravir Long-Acting Injectable

Drug: RPV-LA Maintenance Dose
600 mg administered as one 2 mL (600 mg) intramuscular injection in the gluteal muscle
Other Name: Rilpivirine Long-Acting Injectable

Drug: CAB-LA Maintenance Dose
400 mg administered as one 2 mL (400 mg) intramuscular injection in the gluteal muscle
Other Name: Cabotegravir Long-Acting Injectable




Primary Outcome Measures :
  1. Time to regimen failure in Step 2 [ Time Frame: Measured through Step 2, Week 52 ]
    Time will be measured from Step 2 randomization to the first of the following two events: virologic failure or permanent discontinuation of randomized study treatment


Secondary Outcome Measures :
  1. Time to virologic failure in Step 2 [ Time Frame: Measured through Step 2, Week 52 ]
    Virologic failure is defined as confirmed HIV-1 RNA greater than 200 copies/mL after Step 2 randomization

  2. Time to the treatment-related failure in Step 2 [ Time Frame: Measured through Step 2, Week 52 ]
    Time will be measured from the Step 2 randomization to the first of the following events: virologic failure or treatment discontinuation due to adverse event (AE)

  3. Number of participants with virologic success [ Time Frame: Measured through Step 2, Week 48 ]
    Virologic success will be defined by the US Food and Drug Administration (FDA) Snapshot algorithm

  4. Number of participants with plasma HIV-1 RNA level less than 50 copies/mL [ Time Frame: Measured through Step 2, Week 52 ]
  5. Frequency of AEs [ Time Frame: Measured through Step 2, Week 52 ]
    AEs will be graded based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017

  6. Time to discontinuation of randomized treatment in Step 2 [ Time Frame: Measured through Step 2, Week 52 ]
    Time will be measured from Step 2 randomization to the permanent discontinuation of randomized study treatment.

  7. Summary score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) [ Time Frame: Measured through Step 2, Week 52 ]
  8. Pill count in Step 1 [ Time Frame: Measured through Step 1, Week 24 ]
  9. Pill count for participants who randomized to SOC arm in Step 2 [ Time Frame: Measured through Step 2, Week 52 ]
  10. Frequency of missed or delayed injections for participants who received LA ART in Step 2 [ Time Frame: Measured through Step 2, Week 52 ]
  11. Summary scores of HIV Treatment Adherence Self-Efficacy Scale [ Time Frame: Measured through Step 2, Week 52 ]
  12. Frequency of new drug-resistance mutations in participants with virologic failure in Step 2 [ Time Frame: Measured through Step 2, Week 52 ]
    Summarized and tabulated by randomized treatments

  13. Frequency of Injection Site Reactions (ISR) during Step 2 [ Time Frame: Measured through Step 2, Week 52 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Step 1 Inclusion Criteria

  • HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.

    • NOTE: The term "licensed" refers to a FDA-approved kit, which is required for all IND studies.
    • WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.
  • HIV-1 Plasma viral load (VL) greater than 200 copies/mL within 60 days prior to study entry by any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent.
  • Evidence of non-adherence to ART according to at least one of the following criteria:

    • Poor virologic response within 18 months prior to study entry (defined as less than 1 log10 decrease in HIV-1 RNA or HIV-1 RNA greater than 200 copies/mL at two time points at least 4 weeks apart) in individuals who have been prescribed ART for at least 6 consecutive months.
    • Lost to clinical follow-up within 18 months prior to study entry with ART non-adherence for greater than or equal to 6 consecutive months.
    • NOTE: Lost to clinical follow-up is defined as either no contact with provider or missed greater than or equal to 2 appointments in a 6-month period. ART non-adherence is defined as a lapse in ART greater than or equal to 7 days (consecutive or non-consecutive), in the 6-month period where they were lost to clinical follow-up per participant report.
  • No evidence of any clinically relevant RPV or INSTI resistance-associated mutations (see Manual of Procedures [MOPS] for list of exclusionary mutations) through commercially available genotypic (or phenotypic, if available) analyses from any laboratory that has a CLIA certification or its equivalent within 60 days of study entry (see protocol for more information), nor history of such mutations on review of prior resistance tests by the site investigator. Genotypic analysis using proviral (i.e., archived) DNA is not allowed.
  • Ability of site clinician, in conjunction with participant, to construct an oral induction antiretroviral (ARV) regimen that must include at least three ARVs of which at least two must be predicted to be fully active. The regimen must, include PI/cobi and/or an INSTI based on screening and/or historic resistance testing.
  • Laboratory values obtained within 60 days prior to study entry by any laboratory that has a CLIA certification or its equivalent:

    • Hemoglobin greater than or equal to 9.0 g/dL
    • Absolute neutrophil count (ANC) greater than or equal to 600/mm^3
    • Alanine aminotransferase (ALT) less than or equal to 3 x upper limit of normal (ULN)
    • Creatinine Clearance (CrCl) greater than or equal to 50 mL/min estimated by Cockcroft-Gault
    • NOTE: A calculator for estimating the CrCl can be found at www.fstrf.org/ACTG/ccc.html.
  • For women of reproductive potential, negative serum or urine pregnancy test with a sensitivity of less than or equal to 25 mIU/mL at screening. This will be repeated again at study entry.

    • NOTE: Female participants are considered to be NOT of reproductive potential if: 1) they have had amenorrhea for at least 12 consecutive months prior to study entry ((i.e., who have had no menses within 12 months prior to study entry), and have a documented follicle-stimulating hormone (FSH) greater than 40 IU/mL; OR 2) an FSH level is not available, but they have had 24 consecutive months of amenorrhea (in the absence of medications known to induce amenorrhea); OR 3) they report having undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation/hysteroscopic tubal occlusion).
  • Contraception requirements

    • Female Participants of Reproductive Potential: Female participants of reproductive potential, who are participating in sexual activity that could lead to pregnancy, must agree to use at least one of the listed highly effective methods for contraception from 30 days prior to the first dose of study medication, while receiving the study drugs, and for 30 days after stopping oral medications, or the duration specified in the product label if receiving study drugs not supplied by the study, or 52 weeks after stopping RPV-LA or CAB-LA. Acceptable methods of contraception include:

      • Contraceptive subdermal implant
      • Intrauterine device or intrauterine system
      • Combined estrogen and progestogen oral contraceptive
      • Injectable progestogen
      • Contraceptive vaginal ring
      • Percutaneous contraceptive patches
    • Female Participants Who Are Not of Reproductive Potential: Women who are not of reproductive potential are eligible to start study drugs without requiring the use of contraceptives. Any statement of self-reported sterility or that of her partner's must be entered in the source documents.
    • NOTE A: Acceptable documentation of lack of reproductive potential is the woman's self-reported history of surgical sterilization, menopause, or male partner's azoospermia.
    • NOTE B: ALL participants in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner.
  • Age greater than or equal to 18 years.
  • Ability and willingness of participant or legal guardian/representative to provide written informed consent.

Step 1 Exclusion Criteria

  • Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding.
  • Participants determined by the Site Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder.

    • NOTE: A participant with a prior history of seizure may be considered for enrollment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the A5359 protocol leadership team (actg.leada5359@fstrf.org) prior to enrollment.
  • Advanced liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) OR history of liver cirrhosis.
  • Chronic Hepatitis C (HCV) with planned or anticipated use of anti-HCV therapy prior to the completion of Step 2.
  • History of or current active hepatitis B (HBV) infection defined as positive HBV surface antigen test or any detectable HBV DNA in participants with isolated HBcAb and HBV DNA as follows:

    • Participants positive for HBsAg are excluded
    • Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and any detectable HBV DNA are excluded
    • NOTE: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
  • Current or anticipated need for chronic anti-coagulation therapy.
  • Unwilling to receive injections, or unable to receive gluteal injections.
  • Tattoo or other condition over gluteus region, which may interfere with interpretation of injection site reaction.
  • Previous use of CAB.
  • Acute or serious illness requiring systemic treatment and/or hospitalization within 7 days prior to entry.
  • QTc greater than 450 ms using either Bazett or Fridericia method within 60 days prior to study entry: Whichever method is used at screening must be used throughout study period.
  • Any serious medical or psychiatric condition, which may render the participant unable to receive study medication in the opinion of the site investigator.
  • Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
  • Requirement for any medication that is prohibited with a study medication (refer to protocol specific web page [PSWP]).

Step 2 Inclusion Criteria

  • HIV-1 RNA less than 50 copies/mL at Step 1, week 20, or HIV-1 RNA of 50-399 copies/mL at Step 1, week 20, followed by HIV-1 RNA less than 50 copies/mL by Step 1, week 24.

Step 2 Exclusion Criteria

  • Permanent discontinuation of study treatment for any reason during Step 1.
  • Participants who never started study treatment in Step 1 (see protocol for more information)

Step 3 Inclusion Criteria

  • Willingness to continue for those in Arm A or begin to receive LA ART for those in Arm B.
  • Arm B participants: HIV-1 RNA less than 50 copies/mL at Step 2, week 48, or HIV-1 RNA of 50-399 copies/mL at Step 2, week 48, followed by HIV-1 RNA less than 50 copies/mL by Step 2, week 52.

Step 3 Exclusion Criteria

  • Permanent discontinuation of study treatment for any reason during Step 2.

Step 4 Inclusion Criteria

  • Any participant who has received at least one dose of CAB-LA or RPV-LA AND does not have access to commercially available LA ART,
  • OR does not wish to continue LA ART.

Step 4 Exclusion Criteria

  • There are no exclusion criteria for Step 4.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635788


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Alabama CRS Recruiting
Birmingham, Alabama, United States, 35294
Contact: Pamela Cunningham, R.N., B.S.N., M.P.H.    205-975-2841    pamelacunningham@uabmc.edu   
United States, California
University of Southern California CRS Recruiting
Los Angeles, California, United States, 90033-1079
Contact: Luis M. Mendez    323-343-8283    lmendez@usc.edu   
UCLA CARE Center CRS Recruiting
Los Angeles, California, United States, 90035
Contact: Aleen Khodabakhshian    310-557-9027    akhodabakhshian@mednet.ucla.edu   
UCSD Antiviral Research Center CRS Recruiting
San Diego, California, United States, 92103
Contact: Steven Hendrickx, R.N.    619-543-6968    smhendrickx@ucsd.edu   
Ucsf Hiv/Aids Crs Recruiting
San Francisco, California, United States, 94110
Contact: Jay Dwyer    415-476-4082 ext 353    Jay.Dwyer@ucsf.edu   
Harbor-UCLA CRS Recruiting
Torrance, California, United States, 90502
Contact: Mario Guerrero    424-201-3000 ext 7318    mguerrero@labiomed.org   
United States, Colorado
University of Colorado Hospital CRS Recruiting
Aurora, Colorado, United States, 80045
Contact: Suzanne Fiorillo, M.S.P.H.    303-724-5931    suzanne.fiorillo@ucdenver.edu   
United States, Florida
Univ. of Florida Jacksonville NICHD CRS Recruiting
Jacksonville, Florida, United States, 32209
Contact: Saniyyah Mahmoudi, A.R.N.P.    904-244-5331    saniyyah.mahmoudi@jax.ufl.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   
United States, Illinois
Northwestern University CRS Recruiting
Chicago, Illinois, United States, 60611
Contact: Baiba Berzins, M.P.H.    312-695-5012    Baiba@northwestern.edu   
Rush University CRS Recruiting
Chicago, Illinois, United States, 60612
Contact: Antoinette Lewis    312-942-2050    antoinette_lewis@rush.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
Massachusetts General Hospital CRS (MGH CRS) Recruiting
Boston, Massachusetts, United States, 02114
Contact: Theresa Flynn, R.N., M.S.N., A.N.P., B.S.N.    617-724-0072    tflynn@partners.org   
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS Recruiting
Boston, Massachusetts, United States, 02115
Contact: Cheryl E. Keenan, R.N.    617-732-5635    CKeenan@BWH.Harvard.edu   
United States, Missouri
Washington University Therapeutics (WT) CRS Recruiting
Saint Louis, Missouri, United States, 63110-1010
Contact: Michael K. Klebert    314-747-1098    mklebert@wustl.edu   
United States, New Jersey
New Jersey Medical School Clinical Research Center CRS Recruiting
Newark, New Jersey, United States, 07103
Contact: Rondalya DeShields, R.N., B.S.N.    973-972-3729    deshierd@njms.rutgers.edu   
United States, New York
Jacobi Med. Ctr. Bronx NICHD CRS Recruiting
Bronx, New York, United States, 10461
Contact: Marlene Burey, R.N., M.S.N., P.N.P.    718-918-4783    marlene.burey@nychhc.org   
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   
Columbia P&S CRS Recruiting
New York, New York, United States, 10032-3732
Contact: Steven Palmer, P.A. -C    212-342-2958    sp500@cumc.columbia.edu   
Weill Cornell Uptown CRS Recruiting
New York, New York, United States, 10065
Contact: Rebecca Fry, M.S.N., FNP    212-746-4166    ref2007@med.cornell.edu   
SUNY Stony Brook NICHD CRS Recruiting
Stony Brook, New York, United States, 11794
Contact: Erin Infanzon    631-444-8832    Erin.Infanzon@stonybrookmedicine.edu   
United States, North Carolina
Chapel Hill CRS Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Becky Straub, B.S.N., M.P.H., R.N.    919-843-9975    bstraub@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   
Case Clinical Research Site Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jane Baum, R.N.    216-844-2546    jb@clevelandactu.org   
Ohio State University CRS Recruiting
Columbus, Ohio, United States, 43210
Contact: Kathy Watson, B.S.N., R.N.    614-293-5856    kathy.watson@osumc.edu   
United States, Pennsylvania
Penn Therapeutics, CRS Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Eileen B. Donaghy, C.R.N.P.    215-349-8092    eileen.donaghy2@uphs.upenn.edu   
University of Pittsburgh CRS Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Dawn R. Weinman    412-383-1748    drw38@pitt.edu   
United States, Rhode Island
The Miriam Hospital Clinical Research Site (TMH CRS) CRS Recruiting
Providence, Rhode Island, United States, 02906
Contact: Pamela Poethke, R.N.    401-793-4971    ppoethke@lifespan.org   
United States, Tennessee
Vanderbilt Therapeutics (VT) CRS Recruiting
Nashville, Tennessee, United States, 37204
Contact: Beverly O. Woodward, M.S.N., R.N.    615-936-8516    beverly.o.woodward@vumc.org   
United States, Texas
Trinity Health and Wellness Center CRS Recruiting
Dallas, Texas, United States, 75208
Contact: Lauren Rogers, CCRC    972-807-7370    lauren.rogers@aidsarms.org   
Houston AIDS Research Team CRS Recruiting
Houston, Texas, United States, 77030
Contact: Maria L. Martinez    713-500-6718    Maria.L.Martinez@uth.tmc.edu   
United States, Washington
University of Washington AIDS CRS Recruiting
Seattle, Washington, United States, 98104-9929
Contact: Sher Storey, P.A. -C    206-744-3732    sstorey@uw.edu   
Puerto Rico
Puerto Rico AIDS Clinical Trials Unit CRS Recruiting
San Juan, Puerto Rico, 00935
Contact: Sylvia I. Davila Nieves, M.Sc.    787-767-9192    sylvia.davila1@upr.edu   
San Juan City Hosp. PR NICHD CRS Recruiting
San Juan, Puerto Rico, 00936
Contact: Elvia Perez-Hernandez, M.A., M.P.H., B.S., M.Ed.    787-764-3083    eperez@sanjuanciudadpatria.com   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
ViiV
Investigators
Layout table for investigator information
Study Chair: Jose Castillo-Mancilla, M.D. University of Colorado Hospital CRS
Study Chair: Aadia Rana, M.D. Alabama CTU

Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03635788     History of Changes
Other Study ID Numbers: ACTG A5359
30104 ( Registry Identifier: DAIDS-ES Registry Number )
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie results in the publication, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.
Access Criteria:
  • With whom?

    • Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.
  • For what types of analyses?

    • To achieve aims in the proposal approved by the AIDS Clinical Trials Group.
  • By what mechanism will data be made available?

    • Researchers may submit a request for access to data using the AIDS Clinical Trials Group "Data Request" form at: https://actgnetwork.org/about-actg/templates-and-forms. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Rilpivirine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents