Last updated on December 2012

A Trial of Lopinavir/Ritonavir Dosed According to the Who Pediatric Weight Band Dosing Guidelines


Brief description of study

The main purpose of this study is to measure the amount of lopinavir/ritonavir (two anti-HIV medications) in the blood. Results from this study will be compared to the levels of the drugs that have been found in other studies that showed that these medications were safe and effective.

Detailed Study Description

This is a Phase II/III trial to assess the short-term pharmacokinetics, safety, and tolerance of LPV/r in HIV-infected infants and children initiating LPV/r therapy who weigh >3 and <25 kg and are dosed according to the WHO antiretroviral (ARV) weight band dosing guidelines. LPV/r will be administered as the heat-stable pediatric LPV/r 100/25 mg tablet in children who can swallow tablets or the liquid 80/20 mg/mL formulation in children who cannot swallow tablets. LPV/r will be dosed according to the WHO ARV weight band dosing schedule as part of a combination ARV regimen including two NRTIs as background therapy. The NRTI background will be prescribed by the health care provider according to local national and/or international guidelines for treatment of HIV-infected children. LPV/r will be provided as part of the study. The study duration, on treatment, will be 24 weeks.

Clinical Study Identifier: NCT01338038

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Marilyn J Crain .,, M.D., ...

University of Alabama Birmingham NICHD CRS (5096)
Birmingham, AL United States
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Audra Deveikis, MD

Miller Children's Hospital Long Beach NICHD CRS (5093)
Long Beach, CA United States
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Marvin E Belzer, M.D.

Childrens Hospital Los Angeles NICHD CRS (5090)
Los Angeles, CA United States
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Andrea Kovacs, M.D.

USC/Los Angeles County Medical Center NICHD CRS (5048)
Los Angeles, CA United States
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Jin Kim, BS

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
Los Angeles, CA United States
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Stephen A Spector, M.D.

Univ of California, San Diego (4601)
San Diego, CA United States
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Diana W Wara, M.D.

Univiversity of California San Francisco NICHD CRS (5091)
San Francisco,, CA United States
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Margaret Keller, MD

Harbor (UCLA) Medical Center NICHD CRS (5045)
Torrance, CA United States
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Myron Levin, MD

University of Colorado, Denver NICHD CRS (5052)
Aurora, CO United States
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Steven L Zeichner, M.D., Ph.D.

Children's National Med. Ctr. Washington DC NICHD CRS (5015)
Washington, WA United States
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Sohail R. Rana, MD

Howard University Washington, DC NICHD CRS (5044)
Washington, WA United States
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Menachem Miodovnik, M.D.

Washington Hospital Center NICHD CRS (5023)
Washington, WA United States
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Ana M. Puga, M.D.

South Florida CDC Ft. Lauderdale NICHD CRS (5055)
Ft. Lauderdale, FL United States
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Mobeen H. Rathore, M.D.

Univ. of Florida Jacksonville NICHD CRS (5051)
Jacksonville, FL United States
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Charles D. Mitchell, MD

University of Miami Pediatric Perinatal HIV/AIDS CRS (4201)
Miami, FL United States
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Patricia J. Emmanuel, M.D.

Tampa General Hospital NICHD CRS (5111)
Tampa, FL United States
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Patricia J. Emmanuel, M.D.

USF - Tampa NICHD CRS (5018)
Tampa, FL United States
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Ram Yogev, MD

Chicago Children's CRS (4001)
Chicago, IL United States
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James B. McAuley, MD, MPH

Rush University Cook County Hospital NICHD CRS (5083)
Chicago, IL United States
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Russell B. Van Dyke, MD

Tulane University NICHD CRS (5095)
New Orleans, LA United States
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Douglas Watson, M.D.

University of Maryland NICHD CRS (5094)
Baltimore, MD United States
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Jonathan M. Ellen, M.D.

Johns Hopkins University NICHD CRS (5092)
Baltimore, MD United States
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Stephen I. Pelton, MD

Boston Medical Center Ped. HIV Program NICHD CRS (5011)
Boston, MA United States
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Sandra Burchett, M.D.

Brigham and Women's Hospital NICHD CRS (5110)
Boston, MA United States
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Sandra K. Burchett, MD, MS

Children's Hospital of Boston NICHD CRS (5009)
Boston, MA United States
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Katherine Luzuriaga, MD

WNE Maternal Pediatric Adolescent AIDS CRS (7301)
Worcester, MA United States
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Chokechai Rongkavilit, MD

Wayne State University/Children's Hospital of Michigan NICHD CRS (5041)
Detroit, MI United States
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Theodore Jones, M.D.

Hutzel Hospital NICHD CRS (5089)
Detroit, MI United States
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Arry Dieudonne, MD

New Jersey Medical School CRS (2802)
Newark, NJ United States
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Murli U. Purswani, MD

Bronx-Lebanon Hospital IMPAACT CRS (6901)
Bronx, NY United States
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Marlene Burey

Jacobi Med. Ctr. Bronx NICHD CRS (5013)
Bronx, NY United States
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Philip S. LaRussa, M.D.

Columbia IMPAACT CRS (4101)
New York, NY United States
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William Borkowsky, MD

New York University NY NICHD CRS (5012)
New York, NY United States
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Marukh Bamji, MD

Metropolitan Hospital NICHD CRS (5003)
New York, NY United States
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Geoffrey A Weinberg, MD

Strong Memorial Hospital, University of Rochester NICHD CRS (5057)
Rochester, NY United States
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Sharon A. Nachman, MD

SUNY Stony Brook NICHD CRS (5040)
Stony Brook, NY United States
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Coleen K. Cunningham, MD

Duke University Medical Center (DUMC) Pediatric CRS (4701)
Durham, NC United States
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Richard M. Rutstein, M.D.

The Children's Hospital of Philadelphia IMPAACT CRS (6701)
Philadelphia, PA United States
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Edwin Thorpe, MD

Regional Medical Center at Memphis (6502)
Memphis, TN United States
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Patricia M. Flynn, MD, MS

St. Jude/UTHSC CRS (6501)
Memphis, TN United States
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William T Shearer, M.D., Ph.D

Texas Children's Hosp. CRS (3801)
Houston, TX United States
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Jane Hitti, M.D., MPH

University of Washington NICHD CRS (5029)
Seattle, WA United States
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Jane Hitti, M.D

Harborview Medical Center NICHD CRS (5027)
Seattle, WA United States
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Lisa M. Frenkel, M.D.

Seattle Children's Hospital NICHD CRS (5017)
Seattle, WA United States
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Marcelo H. Losso, M.D.

Hospital General de Agudos Buenos Aires Argentina NICHD CRS (5082)
Buenos Aires, Argentina
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Anthony C. Ogwu, B.S.M.B.

Gaborone Prevention/Treatment Trials CRS (12701)
Gaborone, Botswana
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Jorge Pinto, M.D.,D.Sc.

SOM Federal University Minas Gerais Brazil NICHD CRS (5073)
Belo Horizonte, Brazil
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Regis Kreitchmann, M.D,Ph.D.

Hospital Santa Casa NICHD CRS (5098)
Porto Alegre, Brazil
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Breno Riegel Santos, M.D.

Hospital Nossa Senhora da Conceicao CRS (12201)
Porto Alegre, Brazil
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Esau Custódio João (Filho), M.D.

Hospital dos Servidores Rio de Janeiro NICHD CRS (5072)
Rio de Janeiro, Brazil
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Ricardo Hugo S. Oliveira, M.D.

Universidade Federal do Rio de Janeiro NICHD CRS (5071)
Rio de Janeiro, Brazil
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Jose H. da Silva Pilotto, ...

Hospital Geral De Nova Igaucu Brazil NICHD CRS (5097)
Rio de Janeiro, Brazil
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Marinella Della Negra, Ph.D.

Insituto de Infectologia Emilio Ribas NICHD CRS (5075)
Sao Paulo, Brazil
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Marisa M. Mussi-Pinhata, M.D., Ph.D.

Univ of Sao Paulo Brazil NICHD CRS (5074)
Sao Paulo, Brazil
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Irma L. Febo Rodriguez, M.D.

University of Puerto Rico Pediatric HIV/AIDS CRS (6601)
San Juan, Puerto Rico
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Midnela Acevedo-Flores, M.T., M.D.

San Juan City Hosp. PR NICHD CRS (5031)
San Juan, Puerto Rico
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Raziya Bobat, MD

Durban Pediatric HIV CRS (20201)
Durban, South Africa
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Mark F. Cotton, MMed, Ph.D.

Stellenbosch University CRS (8950)
Cape Town, South Africa
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Avye Violari, MD

Soweto IMPAACT CRS (8052)
Johannesburg, South Africa
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Harry Moultrie, M.D.

Harriet Shezi Children's Clinic (8051)
Johannesburg, South Africa
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John A Crump, MB, ChB

Kilimanjaro Christian Medical CRS (12901)
IDC Research Offices, Tanzania
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Kulkanya Chokephaibulkit, M.D.

Siriraj Hospital Mahidol University CRS (8251)
Bangkok, Thailand
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Napawadee Impoolsup, M.D.

Bhumibol Adulyadej Hospital (8355)
Bangkok, Thailand
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Prapap Yuthavisuthi, M.D.

Prapokklao Hospital CRS (8354)
Chantaburi, Thailand
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Sineenart Nimsakul, MD

Chaing Mai University (20101)
Chiang Mai, Thailand
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Pacharee Kantipong, M.D.

Chiang Rai Regional Hospital CRS (8352)
Chiang Rai, Thailand
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Chureeratana Bowonwatanuwong, M.D.

Chonburi Hosp. CRS (8356)
Chonburi, Thailand
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Guttiga Halue, M.D.

Phayao Provincial Hospital CRS (8353)
Phayao, Thailand
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Mary G. Fowler, MD

Makerere University - JHU Research Collaboration (30293)
Kampala, Uganda
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