Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01302847
First received: February 15, 2011
Last updated: July 11, 2016
Last verified: July 2016
  Purpose
Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class. This study will test the safety of and immune response to DTG in HIV-1 infected infants, children, and adolescents.

Condition Intervention Phase
HIV Infections
Drug: Dolutegravir (DTG) film-coated tablets
Drug: DTG granules for suspension
Drug: DTG dispersible tablets
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Toxicity [ Time Frame: From Week 0 to Week 24 ] [ Designated as safety issue: Yes ]
    Defined as all adverse events or lab toxicities of Grade 3 or higher severity, adverse events or lab toxicities of Grade 3 or higher severity judged to be at least possibly attributable to the study medication, termination from treatment due to a drug-related adverse event, or death

  • Pharmacokinetics as assessed by the area under the curve (AUC) [ Time Frame: Over a single 24-hour period at the Day 5 (+5 days) study visit ] [ Designated as safety issue: No ]
    AUC defined as the area under the drug plasma concentration profile over time of dosing interval (predose to 24 hours)


Secondary Outcome Measures:
  • Toxicity [ Time Frame: From Week 0 to Week 48 and beyond ] [ Designated as safety issue: Yes ]
    Defined as all adverse events or lab toxicities of Grade 3 or higher severity, adverse events or lab toxicities of Grade 3 or higher severity judged to be at least possibly attributable to the study medication, termination from treatment due to a drug-related adverse event, or death

  • Plasma HIV-1 RNA less than 400 copies/ml [ Time Frame: At Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Plasma HIV-1 RNA less than 50 copies/ml [ Time Frame: At Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters [ Time Frame: At Day 5 (+5 days) and Weeks 4, 12, and 24 ] [ Designated as safety issue: No ]
    Drug concentration before dosing, after 24 hours, minimal observed concentration, maximum observed concentration, amount of time to clear the drug from the body, volume of distribution after terminal phase, and drug half-life

  • Change in CD4 and CD8 counts and percentages [ Time Frame: From baseline to Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Genotypic and phenotypic measures of resistance [ Time Frame: At baseline and at virologic failure ] [ Designated as safety issue: No ]
  • Disease progression as measured by change in Centers for Disease Control and Prevention (CDC) category [ Time Frame: From baseline to Week 48 or until virologic failure ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: March 2011
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort I: Adolescents 12 to younger than 18 years of age
DTG film-coated tablets
Drug: Dolutegravir (DTG) film-coated tablets

Stage I: Initial starting dose of DTG tablet(s) at approximately 1 mg/kg, to be taken orally once or twice daily.

Stage II: Stage I-approved dose of DTG to be taken orally once or twice daily.

Experimental: Cohort IIA: Children 6 to younger than 12 years of age
DTG film-coated tablets
Drug: Dolutegravir (DTG) film-coated tablets

Stage I: Initial starting dose of DTG tablet(s) at approximately 1 mg/kg, to be taken orally once or twice daily.

Stage II: Stage I-approved dose of DTG to be taken orally once or twice daily.

Experimental: Cohort IIB: Children 6 to younger than 12 years of age
DTG granules for suspension
Drug: DTG granules for suspension

Stage I: DTG granules for suspension, to be taken orally once or twice daily. Dose will vary for each participant.

Stage II: Stage I-approved dose of DTG to be taken orally once or twice daily. (Note: Cohort IIB will not be included in Stage II of the study).

Experimental: Cohort III: Children 2 to younger than 6 years of age
DTG granules for suspension
Drug: DTG granules for suspension

Stage I: DTG granules for suspension, to be taken orally once or twice daily. Dose will vary for each participant.

Stage II: Stage I-approved dose of DTG to be taken orally once or twice daily. (Note: Cohort IIB will not be included in Stage II of the study).

Experimental: Cohort III-DT: Children 2 to younger than 6 years of age
DTG dispersible tablets
Drug: DTG dispersible tablets

Stage I: DTG dispersible tablets, to be taken orally once or twice daily. Dose will vary for each participant.

Stage II: Stage I-approved dose of DTG to be taken orally once or twice daily.

Experimental: Cohort IV: Children 6 months to younger than 2 years of age
DTG granules for suspension
Drug: DTG granules for suspension

Stage I: DTG granules for suspension, to be taken orally once or twice daily. Dose will vary for each participant.

Stage II: Stage I-approved dose of DTG to be taken orally once or twice daily. (Note: Cohort IIB will not be included in Stage II of the study).

Experimental: Cohort IV-DT: Children 6 months to younger than 2 years of age
DTG dispersible tablets
Drug: DTG dispersible tablets

Stage I: DTG dispersible tablets, to be taken orally once or twice daily. Dose will vary for each participant.

Stage II: Stage I-approved dose of DTG to be taken orally once or twice daily.

Experimental: Cohort V: Infants 4 weeks to younger than 6 months of age
DTG granules for suspension
Drug: DTG granules for suspension

Stage I: DTG granules for suspension, to be taken orally once or twice daily. Dose will vary for each participant.

Stage II: Stage I-approved dose of DTG to be taken orally once or twice daily. (Note: Cohort IIB will not be included in Stage II of the study).

Experimental: Cohort V-DT: Infants 4 weeks to younger than 6 months of age
DTG dispersible tablets
Drug: DTG dispersible tablets

Stage I: DTG dispersible tablets, to be taken orally once or twice daily. Dose will vary for each participant.

Stage II: Stage I-approved dose of DTG to be taken orally once or twice daily.


Detailed Description:

DTG is an HIV medicine in the integrase inhibitor drug class. The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of DTG in HIV-1 infected infants, children, and adolescents.

Participation in this study will last approximately 48 weeks, followed by long-term safety follow-up that will last at least 3 years. Participants may be receiving other antiretroviral (ARV) medications while in this study; these medications will be prescribed by participants' doctors and will not be provided by the study. This study has two stages. Stage I will evaluate the short term tolerability and safety of DTG, allowing the selection of a dose for further study in Stage II. Stage II will then provide long-term safety, tolerability, and efficacy data for DTG. Participants will be assigned to one of nine cohorts depending on age (4 weeks to younger than 18 years of age). Participants in cohorts I and IIA will receive DTG film-coated tablets orally once or twice daily, depending on which other ARV medications they are receiving; participants in cohorts IIB, III, IV, and V will receive DTG granules for oral suspension once or twice daily, depending on which other ARV medications they are receiving; and participants in cohorts III-DT, IV-DT, and V-DT will receive DTG dispersible tablets orally once or twice daily, depending on which other ARV medications they are receiving. (All nine cohorts will be included in Stage I of the study; however, Stage II of the study will not include cohort IIB).

Stage I participants will undergo a physical examination and have blood drawn at each of 10 study visits, occurring on Day 0; Day 5 (+5 days); and Weeks 4, 8, 12, 16, 24, 32, 40, and 48. Stage I participants will also have their blood drawn 8 times over 24 hours during the Day 5 (+5 days) study visit to measure the amount of drug in the blood stream. Stage II participants will undergo a physical examination and have blood drawn at each study visit (Day 0; Day 10; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48). Blood, plasma, and urine will also be stored and tested to measure immune response. Females of childbearing potential will undergo pregnancy testing at every study visit. Questionnaires and assessments will be performed at select study visits.

After 48 weeks, all participants will enter long-term safety follow-up and will continue to receive DTG. During this time, participants will undergo a physical examination, blood collection, and questionnaires at most study visits (every 12 weeks for a minimum of 3 years).

  Eligibility

Ages Eligible for Study:   up to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 4 weeks but younger than 18 years of age at study entry
  • Confirmed HIV-1 infection defined as positive results from two samples collected at different time points (see protocol for more information)
  • Subjects must belong to one of the ARV exposure groups below:
  • 1) ARV-treatment experienced (not including receipt of ARVs as prophylaxis or PMTCT)

    • Previously took ARVs as treatment, but not currently taking ARVs:
    • Must have been off treatment for greater than or equal to 4 weeks, OR
    • Currently taking ARVs for treatment but failing:
    • Must be on an unchanged, failing therapeutic regimen within the 4 to 12 weeks prior to screening (less than or equal to 1 log drop in HIV-1 RNA within the 4 to 12 weeks prior to screening). NOTE: Dose adjustments for growth or formula substitutions (i.e., switching from single agent to fixed dose combination) are permitted during this 4 to 12 week period. Substitutions of one ARV within the same class for toxicity or tolerability management, or discontinuation of ARVs are also allowed within the 4 to 12 weeks period. OR
    • For subjects less than 2 years of age, initiated ARVs for treatment less than 4 weeks prior to screening.
  • 2) ARV treatment naive (no exposure to ARVs for treatment; could have received ARVs for prophylaxis or PMTCT)

    • Age less than 2 years
  • If an infant has received nevirapine (NVP) as prophylaxis to prevent mother to child transmission (PMTCT), he or she must have not received NVP for at least 14 days prior to enrollment into Stage I or II.
  • HIV-1 RNA viral load greater than 1,000 copies/mL of plasma at screening. NOTE: For subjects enrolling into cohorts IV, IV-DT, V, and V-DT, the HIV RNA test performed at screening may be pending at the time of enrollment. If the screening HIV RNA is less than or equal to 1000 c/mL, the subject should discontinue study drug (see the protocol for more information).
  • Demonstrated ability or willingness to swallow assigned study medications. NOTE: Film coated tablets MAY NOT be crushed or dissolved. Dispersible tablets MAY NOT be cut and must be used in five milligram intervals.
  • Parent or legal guardian able and willing to provide signed informed consent.
  • Female subjects who are of child bearing potential and who are engaging in sexual activity that could lead to pregnancy, must use two adequate birth control methods while on study and for two weeks after stopping study drug. Hormonal birth control alone (e.g., pills, shots, or slow release inserts placed under/on the skin) would not be considered adequate. An effective, medically accepted barrier method of contraception (e.g., female/male condoms, diaphragm or cervical cap with a cream or gel that kills sperm (excluding nonoxydyl-9), intrauterine device [IUD], others) also must be used during the study. Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV-1 transmission.
  • Males engaging in sexual activity that could lead to HIV-1 transmission must use a condom.
  • Optimized background therapy (OBT):

    • Subjects aged greater than or equal to 2 years of age (Cohorts I, II, III, and III-DT) must have available at least one fully active drug for the OBT to enroll. Historical genotypes obtained within 1 year of screening will be considered by the Protocol Team for determination of fully active drugs if screening genotype testing is inconclusive.
    • Subjects less than 2 years of age (Cohorts IV, IV-DT, V, and V-DT) can enroll if genotype testing has been obtained with results pending. Note: Subjects enrolled with genotype results pending but found to have no active drugs per genotype performed at screening should discontinue study drug (more information can be found in the protocol). However, such subjects who have a greater than 1 log drop in HIV RNA by 4 weeks can continue study drug with approval by the Protocol Team.

Exclusion Criteria:

  • Presence of any active AIDS-defining opportunistic infection
  • At enrollment, subject weighs less than 3.0 kg
  • Known Grade 3 or greater of any of the following laboratory toxicities within 30 days prior to study entry: neutrophil count, hemoglobin, platelets, aspartate aminotransferase (AST), alanine transaminase (ALT), lipase, serum creatinine and total bilirubin. A single repeat within the 30 days is allowed for eligibility determination. NOTE: Grade 3 or greater total bilirubin is allowable, if the subject is on atazanavir (ATV).
  • ANY known Grade 4 laboratory toxicities within 30 days prior to study entry. NOTE: Grade 4 total bilirubin is allowable, if the subject is on ATV.
  • The following liver toxicities within 30 days prior to study entry: ALT greater than 3x the upper limit of normal (ULN) AND direct bilirubin is greater than 2x ULN
  • Any prior history of malignancy, with the exception of localized malignancies such as squamous cell or basal cell carcinoma of the skin
  • Clinical or symptomatic evidence of pancreatitis, as determined by the clinician
  • Use of any disallowed medications at time of screening (see the protocol for a complete list of disallowed medications)
  • Known history of exposure to integrase inhibitor treatment by the subject or subject's mother prior to delivery/cessation of breastfeeding
  • Known resistance to an integrase inhibitor
  • Women who are pregnant or breastfeeding.
  • Subject is currently participating in or has participated in a study with a compound or device that is not commercially available within 30 days of signing informed consent, unless permission from both Protocol Teams is granted
  • Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study to a non-IMPAACT study site
  • Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise the outcome of this study
  • Subject has used, or anticipates using, chronic systemic immunosuppressive agents or systemic interferon (e.g., for treatment of hepatitis C virus [HCV] infection) within 30 days prior to beginning DTG study treatment. Systemic corticosteroids (e.g., prednisone or equivalent up to 2 mg/kg/day) for replacement therapy or short courses (less than or equal to 30 days) are permitted. (See protocol for more information on disallowed medications.)
  • Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
  • Active tuberculosis (TB) disease and/or requirement for treatment that includes rifampin at the time of the screening visit. However, subjects who need rifampin treatment while on DTG will be allowed to continue in P1093 provided the DTG dose is adjusted according to the protocol.
  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: NCT01302847

  Hide Study Locations
Locations
United States, California
University of California, UC San Diego CRS Recruiting
La Jolla, California, United States, 92093-0672
Contact: Daniel R. Szpak, A.D.N., R.N.    858-534-9216    dszpak@ucsd.edu   
Miller Children's Hosp. Long Beach CA NICHD CRS Recruiting
Long Beach, California, United States, 90806
Contact: Janielle Jackson-Alvarez    562-933-8666    jjackson-alvarez@memorialcare.org   
Usc La Nichd Crs Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Eva A. Operskalski, Ph.D.    323-865-1554    eva@usc.edu   
David Geffen School of Medicine at UCLA NICHD CRS Recruiting
Los Angeles, California, United States, 90095-1752
Contact: Michele F. Carter, B.S., R.N.    310-206-6369    mfcarter@mednet.ucla.edu   
Univ. of California San Francisco NICHD CRS Completed
San Francisco, California, United States, 94143
Harbor UCLA Medical Ctr. NICHD CRS Withdrawn
Torrance, California, United States, 90502
United States, Colorado
Univ. of Colorado Denver NICHD CRS Recruiting
Aurora, Colorado, United States, 80045
Contact: Emily Barr, C.P.N.P., CNP, C.N.M., M.S.N.    1-720-777-6752    emily.barr@childrenscolorado.org   
United States, District of Columbia
Howard Univ. Washington DC NICHD CRS Recruiting
Washington, District of Columbia, United States, 20060
Contact: Patricia Houston, M.S.    202-865-4578    phouston@howard.edu   
Children's National Med. Ctr. Washington DC NICHD CRS Withdrawn
Washington, District of Columbia, United States, 20010
United States, Florida
South Florida CDTC Ft Lauderdale NICHD CRS Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Dayana Leon, L.P.N.    954-728-1054    dleon@browardhealth.org   
Pediatric Perinatal HIV Clinical Trials Unit CRS Not yet recruiting
Miami, Florida, United States, 33136
Contact: Monica M. Stone, M.D., M.Sc.    305-243-4447    m.stone@med.miami.edu   
USF - Tampa NICHD CRS Recruiting
Tampa, Florida, United States, 33606
Contact: Denise Casey, R.N., B.S.N., C.C.R.P.    813-259-8674    Dcasey1@health.usf.edu   
United States, Georgia
Emory University School of Medicine NICHD CRS Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Bridget A. Wynn    404-966-1487    bwynn@emory.edu   
United States, Illinois
Rush Univ. Cook County Hosp. Chicago NICHD CRS Recruiting
Chicago, Illinois, United States, 60612
Contact: Maureen McNichols, R.N., M.S.N., C.C.R.C.    312-572-4541    maureen_mcnichols@rush.edu   
Lurie Children's Hospital of Chicago (LCH) CRS Recruiting
Chicago, Illinois, United States, 60614-3393
Contact: Margaret Ann Sanders, M.P.H.    312-227-8275    msanders@luriechildrens.org   
United States, Louisiana
Tulane Univ. New Orleans NICHD CRS Withdrawn
New Orleans, Louisiana, United States, 70112
United States, Maryland
Univ. of Maryland Baltimore NICHD CRS Withdrawn
Baltimore, Maryland, United States, 21201
Johns Hopkins Univ. Baltimore NICHD CRS Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Thuy Anderson, R.N., B.S.N.    443-287-8942    tander34@jhmi.edu   
United States, Massachusetts
Boston Medical Center Ped. HIV Program NICHD CRS Recruiting
Boston, Massachusetts, United States, 02118
Contact: Debra McLaud, RN    617-414-5813    demclaud@bmc.org   
Children's Hosp. of Boston NICHD CRS Completed
Boston, Massachusetts, United States, 02115
WNE Maternal Pediatric Adolescent AIDS CRS Withdrawn
Worcester, Massachusetts, United States, 01605
United States, Michigan
Children's Hospital of Michigan NICHD CRS Withdrawn
Detroit, Michigan, United States, 48201
United States, New Jersey
Rutgers - New Jersey Medical School CRS Withdrawn
Newark, New Jersey, United States, 07103
United States, New York
Bronx-Lebanon CRS Withdrawn
Bronx, New York, United States, 10457
Bronx-Lebanon Hospital Center NICHD CRS Recruiting
Bronx, New York, United States, 10457
Contact: Martha Cavallo, A.N.P., C.R.N.P.    718-960-1010    mcavallo@bronxleb.org   
Jacobi Med. Ctr. Bronx NICHD CRS Recruiting
Bronx, New York, United States, 10461
Contact: Marlene Burey    718-918-4783    marlene.burey@nbhn.net   
Nyu Ny Nichd Crs Withdrawn
New York, New York, United States, 10016
Metropolitan Hosp. NICHD CRS Completed
New York, New York, United States, 10029
SUNY Stony Brook NICHD CRS Not yet recruiting
Stony Brook, New York, United States, 11794-8111
Contact: Denise Ferraro    631-444-8225    denise.ferraro@stonybrook.edu   
United States, North Carolina
DUMC Ped. CRS Completed
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Philadelphia IMPAACT Unit CRS Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sheri McDougall, M.H.S.Ed., C.C.R.C.    1-215-590-0416    MCDOUGALL@email.chop.edu   
United States, Tennessee
St. Jude Children's Research Hospital CRS Not yet recruiting
Memphis, Tennessee, United States, 38105-3678
Contact: Sandra Jones, P.N.P.    901-595-5059    Sandra.Jones2@STJUDE.org   
United States, Texas
Texas Children's Hospital CRS Not yet recruiting
Houston, Texas, United States, 77030-2399
Contact: Chivon D. McMullen-Jackson, B.S.N., A.D.N., R.N.    832-824-1339    cdmcmull@texaschildrens.org   
United States, Washington
Seattle Children's Research Institute CRS Recruiting
Seattle, Washington, United States, 98101
Contact: Amanda Robson Nuss, B.S.    206-884-1535    amanda.robson@seattlechildrens.org   
Argentina
Hosp. General de Agudos Buenos Aires Argentina NICHD CRS Not yet recruiting
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1221ADC
Contact: Silvia A. Ivalo, M.D.    54-11-49315252    sivalo@hivramos.org.ar   
Botswana
Molepolole CRS Not yet recruiting
Gaborone, Kweneng District, Botswana
Contact: Ayotunde Omoz-Oarhe, MDCM, M.D.    267-3910388    aomozoarhe@bhp.org.bw   
Gaborone CRS Not yet recruiting
Gaborone, South-East District, Botswana
Contact: Tebogo Kakhu    267-3931353    tkakhu@bhp.org.bw   
Brazil
SOM Federal University Minas Gerais Brazil NICHD CRS Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30.130-100
Contact: Flavia G. Ferreira, M.D., D.Sc.    55-31-34099111    ffaleiroferreira@gmail.com   
Hospital Nossa Senhora da Conceicao NICHD CRS Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
Contact: Rita d. Lira, M.D.    55-51-33572603    Lrita@ghc.com.br   
Hospital Federal dos Servidores do Estado NICHD CRS Not yet recruiting
Rio de Janeiro, Brazil, 20221-903
Contact: Leon C. Sidi, M.D.    55-21-22330018    leon@diphse.com.br   
Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS Recruiting
Rio de Janeiro, Brazil, 21941-612
Contact: Maria da Conceicao C. Sapia, M.D.    55-21-31482255    macher.rlk@terra.com.br   
Hosp. Geral De Nova Igaucu Brazil NICHD CRS Recruiting
Rio de Janeiro, Brazil, 26030
Contact: Gisely G. Falco    55-21-26676059    gisely.falco@gmail.com   
Univ. of Sao Paulo Brazil NICHD CRS Recruiting
Sao Paulo, Brazil, 14049-900
Contact: Adriana A. Barbaro    55-1632345516    a.tiraboschi@uol.com.br   
Puerto Rico
San Juan City Hosp. PR NICHD CRS Withdrawn
San Juan, Puerto Rico, 00936
South Africa
Shandukani Research CRS Recruiting
Johannesburg, Gauteng, South Africa, 2001
Contact: Hermien Gous, Pharm.D.    27-11-3585500 ext 5502    hgous@wrhi.ac.za   
Umlazi CRS Recruiting
Durban, KwaZulu-Natal, South Africa, 4001
Contact: Vani Chetty    27-31-2601998    Chettyv1@ukzn.ac.za   
Fam-Cru Crs Recruiting
Tygerberg, Western Cape Province, South Africa, 7505
Contact: Joan Coetzee    27-21-9384157    joan@sun.ac.za   
Tanzania
Kilimanjaro Christian Medical Centre (KCMC) Recruiting
Moshi, Tanzania
Contact: Cynthia A. Asiyo    255-753698484    casiyo@gmail.com   
Thailand
Siriraj Hospital ,Mahidol University NICHD CRS Recruiting
Bangkok, Bangkoknoi, Thailand, 10700
Contact: Watcharee Lermankul    66-2-4197000 ext 5695    watchareeped@gmail.com   
Siriraj Hospital Mahidol University CRS Withdrawn
Bangkok, Bangkoknoi, Thailand, 10700
Chiang Mai University Pediatrics-Obstetrics CRS Withdrawn
Chiang Mai, Thailand, 50200
Chiangrai Prachanukroh Hospital NICHD CRS Recruiting
Chiang Mai, Thailand, 50100
Contact: Pra-ornsuda Sukrakanchana    66-81-7468858    Pra-ornsuda.Sukrakanchana@phpt.org   
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS Recruiting
Chiang Mai, Thailand, 50200
Contact: Daralak Tavornprasit, R.N., M.Sc.    66-898507866    daralak@rihes-cmu.org   
Institut de Recherche pour Developpement (IRD) - PHPT CRS Withdrawn
Chiang Mai, Thailand, 50100
Chonburi Hosp. CRS Withdrawn
Chonburi, Thailand, 20000
Zimbabwe
Harare Family Care CRS Not yet recruiting
Harare, Zimbabwe
Contact: Sukunena J. Maturure, RGN    263-712437682    sjmaturure@uzcrc.co.zw   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Andrew Wiznia, M.D. Jacobi Medical Center
Study Chair: Theodore Ruel, M.D. University of California, San Francisco
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01302847     History of Changes
Other Study ID Numbers: P1093  11773  2010-020988-20  IMPAACT P1093 
Study First Received: February 15, 2011
Last Updated: July 11, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Integrase Inhibitors
Infant
Child
Adolescent

Additional relevant 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
Dolutegravir
Integrase Inhibitors
HIV Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 24, 2016