| 1 |
NCT01618305 |
Active, not recruiting |
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission |
|
- Drug: Lamivudine/zidovudine
- Drug: Efavirenz
- Drug: Raltegravir
|
Interventional
|
Phase 4 |
- Westat
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Plasma HIV-1 viral load less than 200 copies/mL
- Number of participants who discontinue efavirenz or raltegravir (whichever was assigned) prior to labor and delivery for any reason (including loss to follow-up)
- Maternal adverse events of greater than or equal to Grade 3 as defined in the Division of AIDS (DAIDS) toxicity table
- (and 13 more...)
|
394 |
Female |
16 Years and older (Child, Adult, Older Adult) |
NCT01618305 |
P1081
10770
NICHD P1081 |
|
July 2013 |
August 2018 |
July 2019 |
June 13, 2012 |
March 2, 2018 |
|
- University of Southern California Medical Center
Los Angeles, California, United States - David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, United States - Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States - (and 23 more...)
|
|
| 2 |
NCT00099359 |
Completed
Has Results |
Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission |
- Disease Transmission, Vertical
- Vertical Human Immunodeficiency Virus Transmission
- HIV Infections
|
- Drug: Zidovudine
- Drug: Nevirapine (NVP)
- Drug: Epivir (3TC)
- Drug: Nelfinavir (NFV)
|
Interventional
|
Phase 3 |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Infant HIV Infection Status
- Participants With Serious Adverse Events
- Infant HIV-1 Infection Status
- (and 5 more...)
|
1735 |
All |
up to 2 Days (Child) |
NCT00099359 |
NICHD/HPTN 040 (P1043) |
|
February 2004 |
February 2011 |
February 2011 |
December 13, 2004 |
December 4, 2012 |
December 4, 2012 |
- Miller Children's Hospital
Long Beach, California, United States - University of FL
Gainesville, Florida, United States - University of FL-HSC
Jacksonville, Florida, United States - (and 14 more...)
|
|
| 3 |
NCT00341302 |
Completed |
A Prospective, Observational Study of HIV-Infected Pregnant Women and Their Infants at Clinical Sites in Latin American and Caribbean Countries |
|
|
Observational
|
|
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Primary Outcome Measure: To describe the characteristics of HIV-infected pregnant women and their HIV-exposed children in Latin America, including the rates of and risk factors for mother-to-child transmission
- Secondary Outcome Measure: To characterize adverse events according to receipt of and exposure to ARVs (by HIV-infected women during pregnancy and postpartum and by their HIV-exposed but uninfected children in utero and during the first few week...
|
3554 |
Female |
up to 50 Years (Child, Adult) |
NCT00341302 |
999902261
02-CH-N261 |
|
July 25, 2002 |
|
|
June 21, 2006 |
June 13, 2018 |
|
- Hospital General de Agudos "Jose Maria Ramos Mejia"
Buenos Aires, Argentina - Universidade de Caxias do Sul
Caxias do Sul, Brazil - Universidade Federal de Minas Gerais
Minas Gerais, Brazil - (and 9 more...)
|
|
| 4 |
NCT00339612 |
Completed |
NISDI Pediatric Latin American Countries Epidemiologic Study (PLACES): A Prospective Observational Study of HIV-Infected Children at Clinical Sites in Latin American Countries |
|
|
Observational
|
|
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Other
|
- HIV RNA copies
- CD4 + T cell count
|
2129 |
All |
up to 21 Years (Child, Adult) |
NCT00339612 |
999902270
02-CH-N270 |
|
July 30, 2002 |
|
|
June 21, 2006 |
April 5, 2018 |
|
- Universidade Federal de Minas Gerais
Belo Horizonte, Brazil - Ricardo de Souza STD/HIV Clinic-Caxias do Sul
Caxias do Sul, Brazil - Hospital Conceicao
Porto Alegre, Brazil - (and 11 more...)
|
|
| 5 |
NCT01203332 |
Completed |
Identifying Undiagnosed Asymptomatic HIV Infection in Hispanic/Latino Adolescents and Young Adults |
|
- Behavioral: Effectiveness of different strategies in HIV testing and linkage to care
|
Observational
|
|
- University of North Carolina, Chapel Hill
- National Institute on Drug Abuse (NIDA)
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Observational Model: Ecologic or Community
- Time Perspective: Cross-Sectional
|
- Effectiveness of AVT strategy with SSNIT
- Facilitators & barriers to HIV testing
- Sub-group differences
|
1917 |
All |
13 Years to 24 Years (Child, Adult) |
NCT01203332 |
ATN 096 |
|
July 2010 |
January 2013 |
January 2013 |
September 16, 2010 |
February 28, 2017 |
|
- Childrens Hospital Los Angeles
Los Angeles, California, United States - University of California San Francisco
San Francisco, California, United States - Childrens National Medical Center
Washington, District of Columbia, United States - (and 10 more...)
|
|
| 6 |
NCT01701635 |
Active, not recruiting |
SANKOFA Pediatric HIV Disclosure Intervention |
|
- Behavioral: Disclosure intervention
- Behavioral: Enhanced usual care
|
Interventional
|
Not Applicable |
- Yale University
- Purdue University
- University of Ghana
- Kwame Nkrumah University of Science and Technology
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- HIV disclosure rate
- Baseline characteristics of caregiver predictive of disclosure to the child his/her HIV status
- Medication adherence of children
- (and 2 more...)
|
446 |
All |
7 Years to 18 Years (Child, Adult) |
NCT01701635 |
R01HD074253
NIH/NICHD |
|
January 2013 |
June 30, 2017 |
June 30, 2018 |
October 5, 2012 |
January 25, 2018 |
|
- Komfo Anoky Teaching Hospital
Kumasi, Ashanti Region, Ghana - Korle-Bu Teaching Hospital
Accra, Greater Accra Region, Ghana
|
|
| 7 |
NCT00921557 |
Completed
Has Results |
Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents |
|
- Drug: Alendronate
- Drug: Placebo
- Dietary Supplement: Calcium carbonate/vitamin D
|
Interventional
|
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Percent Change From Baseline to Weeks 24 and 48 in Lumbar Spine BMD
- Percentage of Participants Developing New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures
- Percent Change From Baseline to Weeks 24 and 48 in Whole Body (With Head) BMD
- (and 17 more...)
|
52 |
All |
11 Years to 24 Years (Child, Adult) |
NCT00921557 |
P1076
10669
IMPAACT P1076 |
|
November 2009 |
January 2016 |
January 2017 |
June 16, 2009 |
July 21, 2017 |
March 28, 2017 |
- David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, United States - Pediatric Perinatal HIV Clinical Trials Unit CRS
Miami, Florida, United States - USF - Tampa NICHD CRS
Tampa, Florida, United States - (and 7 more...)
|
|
| 8 |
NCT00341796 |
Completed |
Interventions to Decrease the Risk of Mother-to-Child Transmission of HIV in India |
|
|
Observational
|
|
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
400 |
Female |
Child, Adult, Older Adult |
NCT00341796 |
999902214
02-CH-N214 |
|
June 2002 |
|
August 2006 |
June 21, 2006 |
March 4, 2008 |
|
- National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States
|
|
| 9 |
NCT02366533 |
Completed |
CDC-ATN Linkage Evaluation |
|
|
Observational
|
|
- University of North Carolina, Chapel Hill
- National Institute on Drug Abuse (NIDA)
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Administrative Data
- Primary Research Data
|
2133 |
All |
up to 99 Years (Child, Adult, Older Adult) |
NCT02366533 |
ATN 093 |
SMILES and LTC |
May 2010 |
June 2012 |
June 2012 |
February 19, 2015 |
February 28, 2017 |
|
- Children's Hopsital of Los Angeles
Los Angeles, California, United States - Univ of Califormia at San Francisco
San Francisco, California, United States - Children's Hosp National Med Center
Washington, District of Columbia, United States - (and 12 more...)
|
|
| 10 |
NCT00340548 |
Completed |
Host Genetic Factors Influencing HIV1 and HCV Viral Loads and AIDS Clinical Progression in a Hemophilia Cohort (HGDS-3) |
|
|
Observational
|
|
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
333 |
All |
4 Years to 100 Years (Child, Adult, Older Adult) |
NCT00340548 |
999902173
02-C-N173 |
|
April 9, 2002 |
|
|
June 21, 2006 |
April 5, 2018 |
|
- University of California, San Diego
La Jolla, California, United States - Childrens Hospital, Los Angeles
Los Angeles, California, United States - St. Vincent Hospital & Health Care Center
Indianapolis, Indiana, United States - (and 12 more...)
|
|
| 11 |
NCT00065819 |
Completed |
HIV Symptom Management Program for African American Mothers |
|
- Behavioral: HIV Symptom Education Program
|
Interventional
|
Phase 3 |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institute of Nursing Research (NINR)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
|
Female |
Child, Adult, Older Adult |
NCT00065819 |
R01NR004416
RR000466GCRC |
|
September 1996 |
|
August 1999 |
August 4, 2003 |
June 24, 2005 |
|
- University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
|
|
| 12 |
NCT02717494 |
Active, not recruiting |
Safety and Immunogenicity of Anti-Pneumococcal Vaccines in HIV-Infected Pregnant Women |
- PNC Vaccine
- HIV-infected Pregnant Women
|
- Biological: PPV-23
- Biological: PCV-10
- Other: NaCl
|
Interventional
|
Phase 2 |
- Westat
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Safety of PCV10 and PPV23 administered in pregnancy
- Maternal Immunogenicity of PPV23 and PCV10
- Persistence of Transplacentally Transmited Maternal Antibodies to PNC Vaccine Serotypes in the Infant
- (and 2 more...)
|
345 |
Female |
Child, Adult, Older Adult |
NCT02717494 |
NICHD P1091 |
|
March 2016 |
May 2019 |
May 2019 |
March 23, 2016 |
April 26, 2018 |
|
- FUNDEP (Belo Horizonte)
Belo Horizonte, Minas Gerais, Brazil - Hospital Geral de Nova Iguaçu Avenida Henrique Duque Estrada Mayer
Nova Iguaçu, Rio De Janeiro, Brazil - Hospital dos Servidores (Rio de Janeiro)
Saude, Rio De Janeiro, Brazil - (and 5 more...)
|
|
| 13 |
NCT00107549 |
Completed |
Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy |
|
- Biological: rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)])
- Biological: rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349])
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Development of any adverse events of Grade 3 or higher
- Development of adverse events of Grade 3 or higher attributed to the study vaccines
- Viral breakthrough to greater than 1,000 copies/ml
|
20 |
All |
18 Years to 24 Years (Adult) |
NCT00107549 |
P1059
10051
PACTG P1059 |
|
|
|
February 2009 |
April 6, 2005 |
May 18, 2012 |
|
- Children's Hospital Los Angeles NICHD CRS
Los Angeles, California, United States - Usc La Nichd Crs
Los Angeles, California, United States - Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States - (and 6 more...)
|
|
| 14 |
NCT00494273 |
Completed |
HIV Prevention in Haitian American Adolescents |
|
- Behavioral: Cognitive Behavioral and Standard Care with Healthy Living
|
Interventional
|
Phase 1
Phase 2 |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single
- Primary Purpose: Prevention
|
- The BART Condition will reduce HIV transmission risk behavior over time more than the SC. Assessments will be completed prior, after, 4 , 8 and 12 months after the intervention. Measure examples are
- Sexual and Condom Attitudes
- Self-Efficacy Scale
- (and 10 more...)
|
320 |
All |
14 Years to 17 Years (Child) |
NCT00494273 |
R01HD038458 |
|
December 2002 |
December 2006 |
December 2006 |
June 29, 2007 |
October 29, 2014 |
|
- Center for Haitian Studies
Miami, Florida, United States
|
|
| 15 |
NCT00067522 |
Unknown † |
Preventing Unplanned Pregnancies in HIV Infected Zambian Couples |
|
- Behavioral: User-independent contraception program
- Behavioral: Future Planning Perspectives program
|
Interventional
|
Not Applicable |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Single
- Primary Purpose: Prevention
|
|
5000 |
All |
16 Years to 38 Years (Child, Adult) |
NCT00067522 |
HD40125
1R01HD040125-01A1 |
|
January 2002 |
|
|
August 25, 2003 |
June 29, 2007 |
|
- Zambia Emory HIV Research Project
Lusaka, Zambia
|
|
| 16 |
NCT00000751 |
Completed |
A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT) |
|
- Drug: Anti-HIV Immune Serum Globulin (Human)
- Drug: Globulin, Immune
- Drug: Zidovudine
|
Interventional
|
Phase 3 |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
|
|
1600 |
Female |
13 Years to 60 Years (Child, Adult) |
NCT00000751 |
ACTG 185 |
|
|
|
August 2007 |
August 31, 2001 |
September 30, 2008 |
|
- UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States - Los Angeles County - USC Med Ctr
Los Angeles, California, United States - UCLA Med Ctr / Pediatric
Los Angeles, California, United States - (and 48 more...)
|
|
| 17 |
NCT03263195 |
Recruiting |
Prospective Cohort Study of HIV and Zika in Infants and Pregnancy |
- HIV
- Zika Virus
- Pregnant Women
|
|
Observational
|
|
- Westat
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Enrollment (150 HIV-infected and 50 HIV-uninfected pregnant women within one year, with a minimum of 20 of these women having HIV/ZIKV co-infection by their end of pregnancy).
- Viral suppression (in HIV-infected women with ZIKV co-infection compared to those without ZIKV co-infection during pregnancy and at the time of delivery).
- Incidence of ZIKV infection (among pregnant women with HIV infection compared to those without HIV infection).
- (and 8 more...)
|
3800 |
Female |
15 Years and older (Child, Adult, Older Adult) |
NCT03263195 |
HIV-ZIP |
HIV ZIP |
August 23, 2017 |
July 2024 |
July 2024 |
August 28, 2017 |
February 7, 2018 |
|
- University of Miami Pediatric/Prenatal HIV/AIDS
Miami, Florida, United States - South Florida Children's Diagnostic and Treatment Center, Inc.
Pompano Beach, Florida, United States - Bronx-Lebanon Hospital Center NICHD CRS
Bronx, New York, United States - (and 7 more...)
|
|
| 18 |
NCT00016718 |
Completed
Has Results |
Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs |
|
- Drug: Didanosine (ddI)
- Drug: Efavirenz (EFV)
- Drug: Emtricitabine (FTC)
|
Interventional
|
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment.
- Proportion of Participants With Suppression of HIV Viral Load to Less Than 400 Copies/ml at Week 16
- Proportion of Participants With Suppression of HIV Viral Load to Less Than 50 Copies/ml at Week 16
|
43 |
All |
90 Days to 21 Years (Child, Adult) |
NCT00016718 |
P1021
10038
ACTG P1021
PACTG P1021
IMPAACT P1021 |
|
August 2001 |
January 2009 |
January 2009 |
August 31, 2001 |
October 17, 2017 |
October 17, 2017 |
- UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States - UCSF Pediatric AIDS CRS
San Francisco, California, United States - Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States - (and 15 more...)
|
|
| 19 |
NCT00006324 |
Completed |
Hormonal Birth Control and the Risk of Acquiring HIV |
|
- Drug: Ethinyl estradiol/levonorgestrel
- Drug: Medroxyprogesterone acetate
|
Interventional
|
Not Applicable |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Primary Purpose: Treatment
|
|
6360 |
Female |
16 Years to 35 Years (Child, Adult) |
NCT00006324 |
HIVNET 021 |
|
December 1999 |
|
December 2002 |
August 31, 2001 |
August 7, 2008 |
|
- Amy Lovvorn
Research Triangle Park, North Carolina, United States
|
|
| 20 |
NCT00006064 |
Completed |
The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children |
- HIV Infections
- HIV Wasting Syndrome
- Lipodystrophy
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
|
|
100 |
All |
1 Month to 12 Years (Child) |
NCT00006064 |
P1010
10814
PACTG P1010
ACTG P1010 |
|
June 2000 |
|
February 2005 |
August 31, 2001 |
October 29, 2014 |
|
- Jacobi Med. Ctr. Bronx NICHD CRS
Bronx, New York, United States - Texas Children's Hosp. CRS
Houston, Texas, United States - University of Puerto Rico Pediatric HIV/AIDS Research Program CRS
San Juan, Puerto Rico
|
|
| 21 |
NCT00485264 |
Completed
Has Results |
Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents |
|
- Drug: Raltegravir poloxamer film coated tablet
- Drug: Raltegravir chewable tablet
- Drug: Raltegravir oral granules for suspension (20 mg/mL)
|
Interventional
|
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)
- Number of Participants Terminated From Treatment Due to Suspected Adverse Drug Reaction (SADR) Attributable to the Study Medication
- Number of Participants Who Died
- (and 7 more...)
|
153 |
All |
up to 18 Years (Child, Adult) |
NCT00485264 |
P1066
10495
IMPAACT P1066 |
|
September 17, 2007 |
June 3, 2013 |
May 18, 2017 |
June 12, 2007 |
March 29, 2018 |
December 22, 2014 |
- Usc La Nichd Crs
Alhambra, California, United States - University of California, UC San Diego CRS
La Jolla, California, United States - Children's Hospital of Los Angeles NICHD CRS
Los Angeles, California, United States - (and 39 more...)
|
|
| 22 |
NCT00729391 |
Completed |
Women-Focused HIV Prevention in the Western Cape |
- HIV
- Substance Abuse
- Violence
|
- Behavioral: Woman-Focused Intervention (Women's Health CoOp)
- Behavioral: Nutrition (Attention-Control)
- Behavioral: VCT Only
|
Interventional
|
Phase 2
Phase 3 |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Medical Research Council, South Africa
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Reduction in substance abuse, sexual risk behaviors and victimization.
- The moderating effect of victimization and the mediating effects of HIV risk knowledge, condom skills, sexual negotiation assertiveness, and relationship power on the effectiveness of the woman-focused groups.
|
720 |
Female |
18 Years to 33 Years (Adult) |
NCT00729391 |
R01HD058320 |
WC-WHC |
September 26, 2008 |
January 2012 |
March 2012 |
August 7, 2008 |
May 18, 2017 |
|
- Cape Town, Western Cape, South Africa
|
|
| 23 |
NCT00766597 |
Completed
Has Results |
Safety and Immune Response to Vicriviroc in Combination Regimens in HIV-Infected ART Experienced Children and Adolescents |
|
|
Interventional
|
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Suspected Adverse Drug Reaction Leading to Treatment Termination
- Number of Participants With Adverse Events of Grade 3 or Higher Severity
- Number of Participants Who Failed to Meet PK Targets
- (and 6 more...)
|
9 |
All |
2 Years to 18 Years (Child, Adult) |
NCT00766597 |
P1071
10634
IMPAACT P1071 |
|
August 2009 |
July 2010 |
August 2010 |
October 6, 2008 |
February 1, 2016 |
February 1, 2016 |
- UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States - Children's National Med. Ctr. Washington DC NICHD CRS
Washington, District of Columbia, United States - Howard Univ. Washington DC NICHD CRS
Washington, District of Columbia, United States - (and 6 more...)
|
|
| 24 |
NCT00000879 |
Completed |
A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers |
- HIV Infections
- HIV Seronegativity
|
- Biological: ALVAC(2)120(B,MN)GNP (vCP1452)
- Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
- Biological: ALVAC-HIV MN120TMG (vCP205)
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Masking: Double
- Primary Purpose: Prevention
|
|
48 |
All |
up to 3 Days (Child) |
NCT00000879 |
ACTG 326
PACTG 326
10601 |
|
|
|
April 2005 |
August 31, 2001 |
May 18, 2012 |
|
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States - Children's Hosp. of Orange County
Orange, California, United States - UCSF Pediatric AIDS CRS
San Francisco, California, United States - (and 14 more...)
|
|
| 25 |
NCT00039741 |
Completed
Has Results |
Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children |
|
- Drug: NRTIs (ABC, FTC, FTC/TDF, 3TC, 3TC/AZT, d4T, TDF, ddC, AZT)
- Drug: NNRTIs (EFV, NVP)
- Drug: PIs (AMP, IDV, LPV/r, NFV, SQV, RTV)
|
Interventional
|
Phase 2
Phase 3 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- PENTA Foundation
|
NIH / Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml
- Rate of Grade 3 or Higher Signs, Symptoms, or Laboratory Abnormalities Experienced
- Participants With Significant HIV-related Clinical Events, Defined as CDC Category C (AIDS Defining) Diagnoses (Except for Recurrent Bacterial Infections)or Death
- (and 6 more...)
|
266 |
All |
up to 18 Years (Child, Adult) |
NCT00039741 |
P390
PENPACT-1B
10106
PENTA 9/PACTG 390 |
|
August 2002 |
August 2009 |
March 2010 |
June 11, 2002 |
November 23, 2015 |
April 24, 2012 |
- Usc La Nichd Crs
Alhambra, California, United States - Miller Children's Hosp. Long Beach CA NICHD CRS
Long Beach, California, United States - Children's Hospital of Los Angeles NICHD CRS
Los Angeles, California, United States - (and 28 more...)
|
|
| 26 |
NCT00339040 |
Completed
Has Results |
Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children |
- HIV Infections
- Sexually Transmitted Diseases
|
- Biological: Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)
- Other: Placebo/QHPV
|
Interventional
|
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs)
- Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Attributed to Study Treatment
- Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion
- (and 4 more...)
|
130 |
All |
7 Years to 12 Years (Child) |
NCT00339040 |
P1047
10163
PACTG P1047 |
|
October 2006 |
August 2009 |
August 2009 |
June 20, 2006 |
January 13, 2015 |
January 16, 2012 |
- Usc La Nichd Crs
Alhambra, California, United States - Miller Children's Hosp. Long Beach CA NICHD CRS
Long Beach, California, United States - UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States - (and 31 more...)
|
|
| 27 |
NCT00038480 |
Completed |
Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants |
|
- Drug: Lopinavir/Ritonavir
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Trough concentration of LPV and pharmacokinetic parameters
- Recurrent treatment-related Grade 3 and non-life threatening Grade 4 toxicity or single occurence of life-threatening Grade 4 toxicity
- Change in CD4 and CD8 count and percentage from baseline. HIV-1 specific CD4 count and CD8 mediated and humoral responses
- (and 2 more...)
|
31 |
All |
up to 6 Months (Child) |
NCT00038480 |
P1030
10041
PACTG P1030 |
|
|
|
September 2007 |
June 3, 2002 |
May 21, 2012 |
|
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States - UCSF Pediatric AIDS CRS
San Francisco, California, United States - Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States - (and 14 more...)
|
|
| 28 |
NCT00076791 |
Completed |
Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants |
|
- Drug: Emtricitabine/Tenofovir disoproxil fumarate
- Drug: Tenofovir disoproxil fumarate
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
|
NIH / Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Adverse experiences with a severity of Grade 3 or 4 and adverse pregnancy outcomes that cannot be directly attributed to a cause besides study treatment
- Maternal viral load
- viral resistance to emtricitabine/tenofovir disoproxil fumarate using bulk sequencing
- infant HIV DNA PCR
|
66 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00076791 |
P394
10034
PACTG 394
IMPAACT 394 |
|
March 2004 |
March 2010 |
March 2011 |
February 6, 2004 |
July 9, 2013 |
|
- Children's National Med. Ctr. Washington DC NICHD CRS
Washington, District of Columbia, United States - Washington Hosp. Ctr. NICHD CRS
Washington, District of Columbia, United States - Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States - (and 9 more...)
|
|
| 29 |
NCT00006604 |
Completed
Has Results |
Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents |
|
|
Interventional
|
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
|
NIH / Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants Who Experienced a Safety Endpoint of Interest Attributed to ATV
- Number of Participants Who Died
- Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC24h)
- (and 12 more...)
|
195 |
All |
91 Days to 21 Years (Child, Adult) |
NCT00006604 |
P1020A
10037
IMPAACT P1020A
PACTG P1020-A
ACTG P1020-A |
|
November 2000 |
October 2011 |
September 2014 |
August 31, 2001 |
April 5, 2016 |
April 5, 2016 |
- UAB Pediatric Infectious Diseases CRS
Birmingham, Alabama, United States - Usc La Nichd Crs
Alhambra, California, United States - University of California, UC San Diego CRS
La Jolla, California, United States - (and 33 more...)
|
|
| 30 |
NCT00000590 |
Completed |
Anti-HIV Immunoglobulin (HIVIG) in Prevention of Maternal-Fetal HIV Transmission (Pediatric ACTG Protocol 185) |
- Acquired Immunodeficiency Syndrome
- Disease Transmission, Vertical
- HIV Infections
|
|
Interventional
|
Phase 3 |
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Randomized
- Masking: Double
- Primary Purpose: Prevention
|
|
|
All |
18 Years to 40 Years (Adult) |
NCT00000590 |
310 |
|
September 1991 |
|
December 1996 |
October 28, 1999 |
April 14, 2016 |
|
|
|
| 31 |
NCT00006066 |
Completed |
Interleukin-2 Plus Anti-HIV Therapy in HIV-Infected Children With Weakened Immune Systems |
|
- Biological: Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
- Biological: Diphtheria and Tetanus Toxoids Adsorbed
- Biological: Tetanus and Diphtheria Toxoids Adsorbed
- (and 2 more...)
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Primary Purpose: Treatment
|
|
92 |
All |
2 Years to 18 Years (Child, Adult) |
NCT00006066 |
ACTG 402
10607
PACTG 402 |
|
|
|
June 2006 |
August 31, 2001 |
May 21, 2012 |
|
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States - Usc La Nichd Crs
Los Angeles, California, United States - UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States - (and 11 more...)
|
|
| 32 |
NCT00017719 |
Completed |
Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy |
|
- Drug: Lamivudine
- Drug: Lamivudine/Zidovudine
- Drug: Nelfinavir mesylate
- (and 2 more...)
|
Interventional
|
Phase 3 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of women in each treatment group who continue on original therapy with virologic suppression to less than 500 copies/ml at 34 weeks gestation (or the last viral load determination prior to delivery)
- proportion of women in each treatment group who continue on original therapy with virologic suppression to less than 500 copies/ml at 48 weeks postpartum
- Proportion of women in each treatment group who continue on original therapy with virologic suppression to less than 50 copies/ml at 34 weeks gestation (or the last viral load determination prior to delivery)
- (and 10 more...)
|
440 |
Female |
14 Years and older (Child, Adult, Older Adult) |
NCT00017719 |
P1022
10192
ACTG P1022
PACTG P1022 |
|
May 2002 |
|
March 2006 |
August 31, 2001 |
November 26, 2013 |
|
- Usc La Nichd Crs
Los Angeles, California, United States - UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States - UCSF Pediatric AIDS CRS
San Francisco, California, United States - (and 46 more...)
|
|
| 33 |
NCT02639754 |
Enrolling by invitation |
Community Intervention for HIV Testing & Care Linkage Among Young MSM in Bulgaria |
- Acquired Immunodeficiency Syndrome
- HIV
|
- Behavioral: Social Network Leader Endorsement
- Behavioral: HIV Counseling
|
Interventional
|
Not Applicable |
- Medical College of Wisconsin
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Change in Frequency of HIV Testing
- Change in Medical Appointment Keeping
|
320 |
Male |
16 Years to 20 Years (Child, Adult) |
NCT02639754 |
PRO00024824
R01HD085833 |
|
December 2015 |
December 2019 |
December 2020 |
December 24, 2015 |
April 20, 2018 |
|
- Health and Social Development Foundation
Sofia, Bulgaria
|
|
| 34 |
NCT03435887 |
Recruiting |
Piloting At-birth Point of Care HIV Testing Strategies in Kenya |
|
- Behavioral: Alere q HIV-1/2 Detect for point of care infant testing
- Behavioral: GeneXpert HIV-1 Qual for point of care infant testing
- Behavioral: HIV DNA PCR testing (Standard of Care)
|
Interventional
|
Not Applicable |
- University of Kansas Medical Center
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Infant age when mother is notified of at-birth (0-2 weeks postnatal) POC and SOC test results
- Infant age when mother is notified of 6-week (3-24 weeks postnatal) POC and SOC test results
- Proportion of infants testing HIV+ at birth compared to 6 weeks
- (and 4 more...)
|
1440 |
Female |
18 Years and older (Adult, Older Adult) |
NCT03435887 |
STUDY00140399
R01HD076673-04S2 |
|
December 2, 2016 |
April 30, 2018 |
April 30, 2018 |
February 16, 2018 |
February 16, 2018 |
|
- University of Kansas Medical Center
Kansas City, Kansas, United States - Kisumu County Hospital
Kisumu, Kenya - Kombewa District Hospital
Kombewa, Kenya - (and 2 more...)
|
|
| 35 |
NCT00086359 |
Completed |
Comparison of Anti-HIV Drug Combinations to Prevent Mother-to-Child Transmission of HIV |
|
- Drug: Abacavir sulfate, lamivudine, and zidovudine
- Drug: Lamivudine/zidovudine
- Drug: Lopinavir/ritonavir
|
Interventional
|
Phase 3 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Proportion of women in each treatment group with virologic suppression to less than 400 copies/ml at 34th week of pregnancy (or last viral load prior to delivery, if delivery occurs before 34th week of pregnancy) while continuing on assigned therapy
- Primary outcome, evaluating ART naive and ART experienced women
- HIV-related health status of women at delivery, determined by CD4 counts and plasma HIV-1 viral load in the two treatment groups and in ART naive and ART experienced women
- (and 7 more...)
|
19 |
Female |
13 Years and older (Child, Adult, Older Adult) |
NCT00086359 |
P1039
10046
PACTG P1039 |
|
July 2004 |
|
September 2007 |
July 1, 2004 |
December 23, 2014 |
|
- Usc La Nichd Crs
Los Angeles, California, United States - UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States - Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States - (and 5 more...)
|
|
| 36 |
NCT00000952 |
Completed |
A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children |
|
- Drug: Ritonavir
- Drug: Lamivudine
- Drug: Zidovudine
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Primary Purpose: Treatment
|
|
60 |
All |
1 Month to 2 Years (Child) |
NCT00000952 |
ACTG 345
10602
PACTG 345 |
|
|
|
January 2004 |
August 31, 2001 |
October 29, 2014 |
|
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States - UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States - Howard Univ. Washington DC NICHD CRS
Washington, District of Columbia, United States - (and 9 more...)
|
|
| 37 |
NCT00004735 |
Completed |
The Effects of Anti-HIV Therapy on the Immune Systems of Children and Young Adults Infected With HIV |
|
- Biological: Tetanus toxoid
- Biological: Hepatitis A Vaccine (Inactivated)
|
Interventional
|
Not Applicable |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- A stimulation index of 3 or greater on at least 2 occasions to tetanus
- positive serologic response to hepatitis A
- four-fold increase over baseline in antibody titers for tetanus
- (and 3 more...)
|
81 |
All |
2 Years to 24 Years (Child, Adult) |
NCT00004735 |
PACTG P1006
10036 |
|
February 2000 |
|
September 2006 |
August 31, 2001 |
October 7, 2013 |
|
- UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States - Usc La Nichd Crs
Alhambra, California, United States - Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States - (and 24 more...)
|
|
| 38 |
NCT00257127 |
Completed |
Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs |
|
- Biological: Pneumococcal 7-valent conjugate vaccine
- Biological: Pneumococcal polysaccharide vaccine
- Biological: Hepatitis B vaccine
- Biological: Measles, mumps, and rubella virus vaccine, live
|
Interventional
|
Not Applicable |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Grade 3 or greater hematologic and chemistry laboratory values, signs, or symptoms not present, as specified by the protocol
- Seropositivity, as determined by antibody levels
- Immunologic memory, as determined by primary and secondary responses, antibody levels, and additional measures of immunologic memory
|
101 |
All |
6 Years to 23 Years (Child, Adult) |
NCT00257127 |
P1061s
10132
PACTG P1061s |
|
February 2006 |
August 2006 |
August 2006 |
November 22, 2005 |
November 11, 2014 |
|
- UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States - Usc La Nichd Crs
Alhambra, California, United States - Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States - (and 23 more...)
|
|
| 39 |
NCT00075907 |
Completed |
Anti-HIV Drug Regimens With or Without Protease Inhibitors and Drug Level Monitoring in HIV Infected Adolescents |
|
- Drug: Efavirenz + 2 NRTIs
- Drug: Lopinavir/Ritonavir + 2 NRTIs
- Procedure: Therapeutic Drug Monitoring
|
Interventional
|
Phase 3 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients achieving viral suppression (viral load less than 1,000 copies/ml) at Week 24 and maintaining suppression through Week 48 while remaining on study treatment
- Proportion of patients achieving virologic suppression (viral load less than 1,000 copies/ml) at Week 24 and maintaining suppression through Week 96 while remaining on study treatment
- adherence measured by MEMS TrackCap Monitors (percentage of doses taken, estimated using the frequency of bottle openings recorded by the MEMS TrackCap Monitors, the MEMS TrackCap Monitor tracking form, and the information recorded on the questionnaires)
- (and 9 more...)
|
240 |
All |
13 Years to 23 Years (Child, Adult) |
NCT00075907 |
PACTG P1034
DAIDS-ES ID 10043 |
|
July 2004 |
|
September 2006 |
January 13, 2004 |
October 7, 2013 |
|
- Usc La Nichd Crs
Alhambra, California, United States - Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States - Children's Hospital of Los Angeles NICHD CRS
Los Angeles, California, United States - (and 10 more...)
|
|
| 40 |
NCT00992836 |
Completed
Has Results |
Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth |
- HIV Infections
- H1N1 Influenza Virus
|
- Biological: Influenza A (H1N1) 2009 monovalent vaccine
|
Interventional
|
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The Number of Participants Who Had at Least One Adverse Event (AE)
- The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine
- Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose
- (and 6 more...)
|
155 |
All |
4 Years to 25 Years (Child, Adult) |
NCT00992836 |
P1088
10840
IMPAACT P1088 |
|
October 2009 |
August 2010 |
August 2010 |
October 9, 2009 |
December 17, 2014 |
February 9, 2012 |
- UAB Pediatric Infectious Diseases CRS
Birmingham, Alabama, United States - Usc La Nichd Crs
Alhambra, California, United States - University of California, UC San Diego CRS
La Jolla, California, United States - (and 34 more...)
|
|
| 41 |
NCT00000864 |
Completed |
A Study to Test the Safety, Tolerance, and Metabolism of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy in Newborn Infants Born to HIV-1 Infected Women |
|
- Drug: Abacavir sulfate
- Drug: Zidovudine
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Primary Purpose: Treatment
|
|
60 |
All |
up to 28 Days (Child) |
NCT00000864 |
ACTG 321
11295
PACTG 321 |
|
|
|
January 2001 |
August 31, 2001 |
May 18, 2012 |
|
- UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States - Usc La Nichd Crs
Los Angeles, California, United States - UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States - (and 10 more...)
|
|
| 42 |
NCT00073424 |
Completed |
Factors Affecting Adherence to Anti-HIV Drug Regimens in Children and Adolescents |
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Time Perspective: Prospective
|
|
200 |
All |
8 Years to 19 Years (Child, Adult) |
NCT00073424 |
PACTG P1042s
10107 |
|
January 2004 |
|
October 2006 |
November 21, 2003 |
June 3, 2013 |
|
- UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States - Phoenix Children's Hosp.
Phoenix, Arizona, United States - Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States - (and 33 more...)
|
|
| 43 |
NCT00084058 |
Completed |
Safety of Saquinavir and High Doses of Lopinavir/Ritonavir in Children With HIV |
|
- Drug: Lopinavir/ritonavir
- Drug: Saquinavir
|
Interventional
|
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Life-threatening adverse events attributable to study drugs
- dose-limiting toxicity, defined as adverse events of Grade 3 or greater attributable to study drug and require dose reduction or interruption but are not judged to be life-threatening by the protocol team
- Pharmacological success, defined as achieving an inhibitory quotient (IQ) of 15 after 2 weeks on high-dose LPV/r without life-threatening or dose-limiting toxicity
- (and 4 more...)
|
26 |
All |
2 Years to 17 Years (Child) |
NCT00084058 |
P1038
10045
PACTG P1038 |
|
|
|
December 2006 |
June 7, 2004 |
May 21, 2012 |
|
- UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States - Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States - UCSF Pediatric AIDS CRS
San Francisco, California, United States - (and 12 more...)
|
|
| 44 |
NCT00810108 |
Completed
Has Results |
Lopinavir/Ritonavir (Kaletra) PK in Children |
- HIV/AIDS Treatment
- HIV Infections
|
- Drug: lopinavir/ritonavir (Kaletra®) tablets
|
Interventional
|
Phase 4 |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- American Association of Colleges of Pharmacy
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Lopinavir Area Under the Curve (AUC)
|
12 |
Female |
6 Years to 17 Years (Child) |
NCT00810108 |
10894 |
|
June 2006 |
May 2009 |
May 2009 |
December 17, 2008 |
July 6, 2012 |
July 6, 2012 |
- University of California, San Diego - Skaggs School of Pharmacy and School of Medicine
San Diego, California, United States - Children's National Medical Center
Washington, District of Columbia, United States
|
|
| 45 |
NCT00102206 |
Completed |
A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy |
|
- Drug: Abacavir sulfate
- Drug: Emtricitabine
- Drug: Lamivudine
- (and 4 more...)
|
Interventional
|
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Tolerability of dual PI-based HAART versus multi-NRTI HAART salvage regimens (time to first intolerant event)
- 95% confidence interval (CI) for change in CD4% computed for PI-containing groups versus PI-sparing group
- 95% CI for change in BMD (both percent change in BMD and change in z-score from baseline) for each treatment group
- (and 6 more...)
|
6 |
All |
4 Years to 21 Years (Child, Adult) |
NCT00102206 |
P1053
10131
PACTG P1053 |
|
|
|
May 2007 |
January 26, 2005 |
May 21, 2012 |
|
- Chicago Children's CRS
Chicago, Illinois, United States - Columbia IMPAACT CRS
New York, New York, United States - SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States - DUMC Ped. CRS
Durham, North Carolina, United States
|
|
| 46 |
NCT00087945 |
Completed |
Blood Levels of Abacavir in HIV Infected Adolescents |
|
- Drug: Abacavir sulfate
- Drug: Abacavir sulfate, lamivudine, and zidovudine
|
Interventional
|
Not Applicable |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
30 |
All |
13 Years to 25 Years (Child, Adult) |
NCT00087945 |
PACTG P1052
10194 |
|
July 2004 |
|
December 2004 |
July 19, 2004 |
October 8, 2013 |
|
- Usc La Nichd Crs
Alhambra, California, United States - Children's Hospital of Los Angeles NICHD CRS
Los Angeles, California, United States - UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States - (and 17 more...)
|
|
| 47 |
NCT01882998 |
Completed |
Primary HIV Prevention in Pregnant and Lactating Ugandan Women |
- Primary Prevention of HIV Acquisition
|
- Behavioral: Extended repeat HIV testing and enhanced counseling
|
Interventional
|
Not Applicable |
- University of California, San Francisco
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Frequency of unprotected sex
- STI incidence
- HIV incidence
- Incidence of recurrent wanted and unwanted pregnancy
|
1230 |
All |
15 Years to 49 Years (Child, Adult) |
NCT01882998 |
R01HD070767
1R01HD070767-01A1 |
PRIMAL |
February 2013 |
May 2016 |
May 2016 |
June 21, 2013 |
May 24, 2016 |
|
- Mulago Hospital
Kampala, Uganda
|
|
| 48 |
NCT00000888 |
Completed |
Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies |
|
- Drug: Ritonavir
- Drug: Lamivudine
- Drug: Zidovudine
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Primary Purpose: Treatment
|
|
14 |
Female |
13 Years and older (Child, Adult, Older Adult) |
NCT00000888 |
ACTG 354
10604
PACTG 354 |
|
|
|
April 2001 |
August 31, 2001 |
May 18, 2012 |
|
- Univ. of Miami Miller School of Medicine - Jackson Memorial Hosp.
Miami, Florida, United States - Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States - Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States - (and 2 more...)
|
|
| 49 |
NCT00000837 |
Completed |
A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children |
|
- Biological: Varicella Virus Vaccine (Live)
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Primary Purpose: Prevention
|
|
127 |
All |
12 Months to 8 Years (Child) |
NCT00000837 |
PACTG 265
10613
ACTG 265 |
|
|
|
November 2005 |
August 31, 2001 |
February 13, 2015 |
|
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States - Usc La Nichd Crs
Los Angeles, California, United States - UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States - (and 22 more...)
|
|
| 50 |
NCT00992017 |
Completed
Has Results |
Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women |
- HIV Infections
- H1N1 Influenza Virus
|
- Biological: Influenza A (H1N1) monovalent vaccine
|
Interventional
|
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The Number of Participants Who Had at Least One Adverse Event (AE)
- The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine
- Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose
- (and 7 more...)
|
130 |
Female |
18 Years to 39 Years (Adult) |
NCT00992017 |
P1086
10835
IMPAACT P1086 |
|
October 2009 |
November 2010 |
November 2010 |
October 8, 2009 |
December 30, 2014 |
March 13, 2012 |
- Usc La Nichd Crs
Alhambra, California, United States - University of California, UC San Diego CRS
La Jolla, California, United States - Miller Children's Hosp. Long Beach CA NICHD CRS
Long Beach, California, United States - (and 28 more...)
|
|
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