Clinical trial NCT02344290: Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults
Official title: Randomized Trial to Prevent Vascular Events in HIV - REPRIEVE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Cardiovascular Diseases
Keywords: HIV
Cardiovascular Disease
Myocardial Infarction
Inflammation
Statin
Computerized Tomography
Cholesterol
COVID-19
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Kowa Pharmaceuticals America, Inc.
name: Gilead Sciences
name: Massachusetts General Hospital
name: NEAT ID Foundation
First posted: 2015-01-22
Enrollment: 7769
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: People with HIV are at risk for cardiovascular disease (CVD). This study evaluated the use of pitavastatin to reduce the risk of CVD in adults with HIV on antiretroviral therapy (ART).

The REPRIEVE trial consisted of two parallel identical protocols:

* REPRIEVE (A5332) was funded by the NHLBI, with additional infrastructure support provided by the NIAID, and was conducted in U.S and select international sites (approximately 120 sites in 11 countries).
* REPRIEVE (EU5332) was co-sponsored by NEAT ID and MGH, and was conducted at 13 sites in Spain.

Detailed description: There are few strategies to prevent CVD in people with HIV (PWH), even though they are at high risk for developing CVD. Statin medications are used to lower cholesterol and may be effective at reducing the risk of CVD in PWH. The purpose of this study was to evaluate the use of pitavastatin to reduce the risk of CVD in PWH on ART.

This study enrolled PWH who were on any ART regimen (ART was not provided by the study) for at least 6 months before study entry and were at low to moderate risk of CVD using the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guideline thresholds for recommended statin initiation.

Participants were randomly assigned to receive 4 mg of pitavastatin or placebo once a day for their entire study duration. Pitavastatin or placebo could be discontinued and clinically indicated statin therapy initiated at the discretion of the site investigator or the participant's care provider, with the intention of following the participant according to the intention-to-treat trial design. Study visits occurred at study entry and Months 1 and 4. Starting at Month 4, study visits occurred every 4 months for the rest of the study. Depending on when participants enrolled, they were in the study for a total of 4 to 8 years. Study visits included medical and medication history reviews, physical examinations, blood collections, assessments and questionnaires, urine collections (for some participants), and an electrocardiogram (ECG) (at study entry only).

Participants at US sites had the option of enrolling in a substudy (Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers: Mechanistic Substudy of REPRIEVE \[A5333s\]). The substudy evaluated the effect of pitavastatin on the progression of non-calcified coronary atherosclerotic plaque (NCP) and inflammatory biomarkers in PWH. Participants in the substudy attended study visits at study entry and Months 4 and 24. The visits included questionnaires and assessments, a blood collection, and a coronary computed tomography angiography (CCTA). The Mechanistic Substudy closed to accrual on February 6, 2018, when its accrual target of 800 participants had been reached. Sites that enrolled participants into the Mechanistic Substudy are indicated with asterisk (\*) at the end of the institution names in the Contacts and Locations section.

Participants enrolled in REPRIEVE from select study sites, including international sites, through December, 2017, were included in the REPRIEVE Kidney Function Objectives Cohort to evaluate the effects of pitavastatin on parameters of kidney function in the setting of HIV. These objectives include evaluating high risk groups and mechanisms driving kidney function decline in the setting of HIV.

Women and men enrolled in REPRIEVE after February, 2016 were included in an observational cohort (REPRIEVE Women's Objectives Cohort) facilitating assessment of sex-specific mechanisms of CVD risk and risk reduction among PWH. This effort also included an evidence-based recruitment campaign to enhance women's participation in REPRIEVE.

In response to the SARS-CoV-2 pandemic, a supplemental objective was added in 2020. To better understand how COVID-19 affects PWH and if pitavastatin may reduce the risk of serious COVID-19 disease, we evaluated interrelated but independent key topics including epidemiology, host factors, and protective strategies. Starting from April 2020, COVID-19 assessment was completed at each study visit, and blood was collected for COVID-19 biomarkers.

The data and safety monitoring board (DSMB) recommended stopping the trial for efficacy at the second planned review on March 30, 2023, and concluded that no unexpected safety concerns had been reported. Following the DSMB action, participants were asked to return for the final study visit. All final visits were completed by August 21, 2023. We here present the results based on the final trial database, including the full follow-up out to closeout visits.

Eligibility criteria: Inclusion Criteria:

* Individual with HIV-1
* Combination antiretroviral therapy (ART) for at least 180 days prior to study entry
* CD4+ cell count greater than 100 cells/mm\^3
* Acceptable screening laboratories including:

  * Fasting low-density lipoprotein (LDL) cholesterol as follows:

    * If ASCVD risk score was less than 7.5%, LDL cholesterol must have been less than 190 mg/dL.
    * If ASCVD risk score was greater than or equal to 7.5% and less than or equal to 10%, LDL must have been less than 160 mg/dL.
    * If ASCVD risk score was greater than 10% and less than or equal to 15%, LDL must have been less than 130 mg/dL.
    * Participants with LDL less than 70 mg/dL were eligible regardless of the 10-year ASCVD risk score, in line with the ACC/AHA 2013 Prevention Guidelines.
  * Fasting triglycerides less than 500 mg/dL
  * Hemoglobin greater than or equal to 8 g/dL for female participants and greater than or equal to 9 g/dL for male participants
  * Glomerular filtration rate (GFR) greater than or equal to 60 mL/min/1.73m\^2 or creatinine clearance (CrCl) greater than or equal to 60 mL/min
  * Alanine aminotransferase (ALT) less than or equal to 2.5 x the upper limit of normal (ULN)
* For persons with known chronic active hepatitis B or C, calculated fibrosis 4 score (FIB-4) must have been less than or equal to 3.25
* Ability and willingness of participant or legal representative to provide written informed consent

Exclusion Criteria:

* Clinical ASCVD, as defined by 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines, including a previous diagnosis of any of the following:

  * Acute myocardial infarction (AMI)
  * Acute coronary syndromes
  * Stable or unstable angina
  * Coronary or other arterial revascularization
  * Stroke
  * Transient ischemic attack (TIA)
  * Peripheral arterial disease presumed to be of atherosclerotic origin
* Current diabetes mellitus with LDL greater than or equal to 70 mg/dL
* 10-year ASCVD risk score estimated by Pooled Cohort Equations greater than 15%
* Active cancer within 12 months prior to study entry, except successfully treated non-melanomatous skin cancer and Kaposi sarcoma without visceral organ involvement
* Known decompensated cirrhosis
* History of myositis or myopathy with active disease in the 180 days prior to study entry
* Known untreated symptomatic thyroid disease
* History of allergy or severe adverse reaction to statins
* Use of specific immunosuppressants or immunomodulatory agents including but not limited to tacrolimus, sirolimus, rapamycin, mycophenolate, cyclosporine, tumor necrosis factor (TNF)-alpha blockers or antagonists, azathioprine, interferon, growth factors, or intravenous immunoglobulin (IVIG) in the 30 days prior to study entry.
* Current use of erythromycin, colchicine, or rifampin
* Use of any statin drugs, gemfibrozil, or PCSK9 inhibitors in the 90 days prior to study entry
* Current use of an investigational new drug that would be contraindicated
* Serious illness or trauma requiring systemic treatment or hospitalization in the 30 days prior to study entry
* Current pregnancy or breastfeeding
* Alcohol or drug use that, in the opinion of the site investigator, would interfere with completion of study procedures
* Other medical, psychiatric, or psychological condition that, in the opinion of the site investigator, would interfere with completion of study procedures and or adherence to study drug

Primary outcomes:
measure: Incidence Rate of Major Adverse Cardiovascular Event (MACE)
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
Secondary outcomes:
measure: Incidence Rate of Cardiac Ischemia or Myocardial Infarction
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Cerebrovascular Event (Stroke or TIA)
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Peripheral Arterial Ischemia
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Death From CV Causes
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Death From CV or Undetermined Causes
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Cardiac Catheterization or Revascularization
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Carotid or Cerebrovascular Revascularization
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Peripheral Arterial Revascularization
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of MACE or Death
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Death (All-cause)
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Non-CV Clinical Diagnoses
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Non-AIDS-defining Cancer
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of AIDS-defining Event
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of End-Stage Renal Disease
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of End-Stage Liver Disease
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Non-fatal Serious Adverse Event
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Diabetes
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Myalgia, Muscle Weakness or Myopathy
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Rhabdomyolysis
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Grade 3 or Higher ALT
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of Adverse Event (AE)
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Fasting Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: At entry and months 12, 24, 36, 48, 60, 72, 84. Participants' follow-up time on study varied, depending on their time of enrollment.
measure: Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
timeFrame: At entry and months 12, 24, 36, 48, 60, 72, 84. Participants' follow-up time on study varied, depending on their time of enrollment.
measure: Incidence Rate of Serious COVID-19
timeFrame: From January 1, 2020 through end of study; the median follow-up time was 3.3 years.
measure: Incidence Rate of COVID-19
timeFrame: From January 1, 2020 through end of study; the median follow-up time was 3.3 years.
measure: For Mechanistic Substudy: Change in Non-Calcified Plaque (NCP) Volume From Baseline to Year 2
timeFrame: Entry and Year 2.
measure: For Mechanistic Substudy: Number of Participants With Progression of NCP From Baseline to Year 2
timeFrame: Entry and year 2.
measure: For Mechanistic Substudy: Change in Total Plaque Volume From Baseline to Year 2
timeFrame: Entry and year 2.
measure: For Mechanistic Substudy: LpPLA2 Level
timeFrame: Entry and month 24.
measure: For Mechanistic Substudy: Change in LpPLA2 From Baseline
timeFrame: Entry and month 24.
measure: For Mechanistic Substudy: HsCRP Level
timeFrame: Entry and month 24.
measure: For Mechanistic Substudy: Change in HsCRP From Baseline
timeFrame: Entry and month 24.
measure: For Mechanistic Substudy: Soluble CD163 Level
timeFrame: Entry and month 24.
measure: For Mechanistic Substudy: Change in Soluble CD163 From Baseline
timeFrame: Entry and month 24.
Other outcomes:
measure: Incidence Rate of MACE by Sex
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
measure: Incidence Rate of MACE by Race
timeFrame: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
Locations:
city: Birmingham
country: United States
facility: Alabama CRS*
state: Alabama
city: Tucson
country: United States
facility: University of Arizona CRS
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California CRS*
state: California
city: Los Angeles
country: United States
facility: UCLA CARE Center CRS*
state: California
city: Los Angeles
country: United States
facility: Mills Clinical Research CRS
state: California
city: Los Angeles
country: United States
facility: VA West Los Angeles Medical Center CRS
state: California
city: Los Angeles
country: United States
facility: Los Angeles LGBT Center CRS
state: California
city: Palm Springs
country: United States
facility: Eisenhower Health Center at Rimrock CRS
state: California
city: Palo Alto
country: United States
facility: Stanford AIDS Clinical Trials Unit CRS
state: California
city: San Diego
country: United States
facility: UCSD Antiviral Research Center CRS*
state: California
city: San Francisco
country: United States
facility: Ucsf Hiv/Aids Crs*
state: California
city: Torrance
country: United States
facility: Harbor-UCLA CRS*
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital CRS*
state: Colorado
city: Denver
country: United States
facility: Denver Public Health CRS
state: Colorado
city: New Haven
country: United States
facility: Yale University CRS
state: Connecticut
city: West Haven
country: United States
facility: VA Connecticut Healthcare System CRS
state: Connecticut
city: Washington
country: United States
facility: Whitman-Walker Health CRS
state: District of Columbia
city: Washington
country: United States
facility: Georgetown University CRS (GU CRS)
state: District of Columbia
city: Washington
country: United States
facility: Capital Medical Associates, PC CRS
state: District of Columbia
city: Washington
country: United States
facility: Infectious Diseases Clinic, Washington DC Veterans Affairs Medical Center CRS
state: District of Columbia
city: Gainesville
country: United States
facility: Malcom Randall VA Medical Center CRS
state: Florida
city: Miami
country: United States
facility: AHF-The Kinder Medical Group CRS
state: Florida
city: Miami
country: United States
facility: The University of Miami AIDS Clinical Research Unit (ACRU) CRS
state: Florida
city: Miami
country: United States
facility: University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS
state: Florida
city: Miami
country: United States
facility: AHF - South Beach CRS
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center CRS
state: Florida
city: Sarasota
country: United States
facility: Community AIDS Network/Comprehensive Care Clinic CRS
state: Florida
city: Tampa
country: United States
facility: Florida Department of Health - Hillsborough County
state: Florida
city: Vero Beach
country: United States
facility: AIDS Research and Treatment Center of the Treasure Coast CRS
state: Florida
city: Atlanta
country: United States
facility: The Ponce de Leon Center CRS
state: Georgia
city: Augusta
country: United States
facility: Augusta University Research Institute, Inc. CRS
state: Georgia
city: Chicago
country: United States
facility: Northwestern University CRS*
state: Illinois
city: Chicago
country: United States
facility: Rush University CRS*
state: Illinois
city: Chicago
country: United States
facility: UIC Project WISH CRS
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Infectious Diseases Research CRS
state: Indiana
city: Iowa City
country: United States
facility: Department of Internal Medicine, University of Iowa Hospitals & Clinics CRS
state: Iowa
city: Lexington
country: United States
facility: Bluegrass Care Clinic/University of Kentucky Research Foundation CRS
state: Kentucky
city: Louisville
country: United States
facility: 550 Clinic -University of Louisville CRS
state: Kentucky
city: New Orleans
country: United States
facility: Tulane - Louisiana Community AIDS Research Program (T-LaCARP) CRS
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University CRS*
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center CRS
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital CRS (MGH CRS)*
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS*
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center CRS
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Infectious Diseases Clinical Research CRS
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hosp. CRS
state: Michigan
city: Southfield
country: United States
facility: St. John Newland Medical Associates CRS
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital CRS
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center CRS
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University Therapeutics (WT) CRS*
state: Missouri
city: Omaha
country: United States
facility: Specialty Care Center CRS
state: Nebraska
city: Camden
country: United States
facility: Cooper Univ. Hosp. CRS
state: New Jersey
city: Newark
country: United States
facility: New Jersey Medical School Clinical Research Center CRS*
state: New Jersey
city: Bronx
country: United States
facility: James J Peters VA Medical Center CRS
state: New York
city: New York
country: United States
facility: Mount Sinai Beth Israel CRS*
state: New York
city: New York
country: United States
facility: VA New York Harbor Healthcare System (NYHHS), NY Campus CRS
state: New York
city: New York
country: United States
facility: Weill Cornell Chelsea CRS*
state: New York
city: New York
country: United States
facility: Mount Sinai Downtown CRS*
state: New York
city: New York
country: United States
facility: Mount Sinai West Samuels CRS*
state: New York
city: New York
country: United States
facility: Mount Sinai St. Luke's Morningside CRS*
state: New York
city: New York
country: United States
facility: Infectious Disease Clinical and Translational Research Center (CTRC) CRS
state: New York
city: New York
country: United States
facility: Columbia P&S CRS*
state: New York
city: New York
country: United States
facility: Weill Cornell Uptown CRS*
state: New York
city: Rochester
country: United States
facility: University of Rochester Adult HIV Therapeutic Strategies Network CRS*
state: New York
city: Chapel Hill
country: United States
facility: Chapel Hill CRS*
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center CRS
state: North Carolina
city: Greensboro
country: United States
facility: Greensboro CRS*
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center CRS
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Clinical Research Site*
state: Ohio
city: Cleveland
country: United States
facility: Case Clinical Research Site*
state: Ohio
city: Columbus
country: United States
facility: Ohio State University CRS*
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center CRS
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma State University Center for Health Sciences CRS
state: Oklahoma
city: Philadelphia
country: United States
facility: Division of Infectious Diseases Clinical Research Center- Drexel University CRS
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Therapeutics, CRS*
state: Pennsylvania
city: Philadelphia
country: United States
facility: Center of Translational AIDS Research, Lewis Katz School of Medicine at Temple University CRS
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Positive Health Clinic CRS
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh CRS*
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital Clinical Research Site (TMH CRS) CRS*
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina: Division of Infectious Diseases CRS
state: South Carolina
city: Columbia
country: United States
facility: Prisma Health CRS
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Therapeutics (VT) CRS*
state: Tennessee
city: Dallas
country: United States
facility: Trinity Health and Wellness Center CRS
state: Texas
city: Dallas
country: United States
facility: Dallas VA Medical Center CRS
state: Texas
city: Dallas
country: United States
facility: UT Southwestern HIV/ID Clinical Trials Unit CRS
state: Texas
city: Houston
country: United States
facility: Houston AIDS Research Team CRS*
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VAMC REPRIEVE CRS
state: Texas
city: Falls Church
country: United States
facility: Inova Heart and Vascular Institute CRS
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University CRS
state: Virginia
city: Seattle
country: United States
facility: University of Washington AIDS CRS*
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin, Inc. CRS
state: Wisconsin
city: Gaborone
country: Botswana
facility: Gaborone CRS
state: South-East District
city: Manaus
country: Brazil
facility: Tropical Medicine Foundation Dr. Heitor Vieira Dourado CRS
state: Amazonas
city: Belo Horizonte
country: Brazil
facility: School of Medicine, Federal University of Minas Gerais CRS
state: Minas Gerais
city: Nova Iguacu
country: Brazil
facility: HGNI HIV Family Care Clinic - HHFCC CRS
state: Rio De Janeiro
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao CRS
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Centro de Referencia e Treinamento DST/AIDS CRS
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Projeto Praça Onze Pesquisa em Saúde CRS
city: Rio de Janeiro
country: Brazil
facility: Hospital Federal dos Servidores do Estado CRS
city: Rio de Janeiro
country: Brazil
facility: Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
city: Sao Paulo
country: Brazil
facility: Instituto de Infectologia Emilio Ribas CRS
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisas Clínicas IC-HCFMUSP CRS
city: Vancouver
country: Canada
facility: Vancouver ID Research & Care Centre Society CRS
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Special Immunology Services Clinic CRS
state: Ontario
city: Toronto
country: Canada
facility: Maple Leaf Research CRS
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital CRS
state: Ontario
city: Montreal
country: Canada
facility: Chronic Viral Illness Service CRS
state: Quebec
city: Quebec City
country: Canada
facility: Centre hospitalier de l'Université Laval CRS
state: Quebec
city: Port-au-Prince
country: Haiti
facility: GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
city: Port-au-Prince
country: Haiti
facility: Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
city: Pune
country: India
facility: Byramjee Jeejeebhoy Medical College (BJMC) CRS
state: Maharashtra
city: Chennai
country: India
facility: Chennai Antiviral Research and Treatment (CART) CRS
state: Tamil Nadu
city: Lima
country: Peru
facility: Barranco CRS
city: Lima
country: Peru
facility: San Miguel CRS
city: San Juan
country: Puerto Rico
facility: Puerto Rico AIDS Clinical Trials Unit CRS*
city: Johannesburg
country: South Africa
facility: Soweto ACTG CRS
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits Helen Joseph Hospital CRS (Wits HJH CRS)
state: Gauteng
city: Durban
country: South Africa
facility: Durban International Clinical Research Site CRS
state: Kwa Zulu Natal
city: Cape Town
country: South Africa
facility: University of Cape Town Lung Institute (UCTLI) CRS
state: Western Cape Province
city: Tygerberg
country: South Africa
facility: Famcru Crs
state: Western Cape Province
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Universitario Valle d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto de Basurto
city: Elche
country: Spain
facility: Hospital General Universitario De Elche
city: Madrid
country: Spain
facility: Hospital Gregorio Universitario Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Bangkok
country: Thailand
facility: Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
city: Chiang Mai
country: Thailand
facility: Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
city: Kampala
country: Uganda
facility: Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site
city: Harare
country: Zimbabwe
facility: Milton Park CRS
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Steven Grinspoon, MD
role: STUDY_CHAIR
References:
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