N/A N=183 Pediatric Urgent Start of Highly Active Antiretroviral Treatment (HAART)
Human Immunodeficiency Virus · Immune Reconstitution Inflammatory Syndrome
Primary: All-cause Mortality — 21; 18 participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=54 Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
Infection, Human Immunodeficiency Virus · HIV Infections
Primary: Plasma Amprenavir (APV) AUC (0-tau[τ]) — 26.6; 64.51; 54.2; 26.22 Hr per microgram/milliliter (hr*µg/mL)
Phase 2 N=138 A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years
HIV Infection
Primary: Number of Participants Who Discontinued Treatment Due to Adverse Events — 12; 3; 3; 1 Participants
Phase 3 N=263 Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children
HIV Infections
Primary: Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml — -3.16; -3.31; -3.26; -3.20 log10 HIV-1 RNA — p=0.26
Phase 4 N=52 IMPAACT P1092: Steady State PK in Malnourished HIV Infected Children
HIV Positive · Malnourished
Primary: Grade 3 or Higher Adverse Events Through 24 Weeks — 13; 10 Participants — p=0.40
Phase 3 N=97 A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines
HIV
Primary: Lopinovir/Ritonavir Area Under the Concentration-time Curve (AUC0-24) — 196 mcg*hr/mL
Phase 3 N=407 Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)
Pneumococcal Infections
Primary: Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™ — 9.4; 5.9; 10.3; 6.4 Percentage of Participants
Phase 2 N=109 48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection
Infection, Human Immunodeficiency Virus I
Primary: Plasma Amprenavir (APV) AUC (0-tau[τ]) — 22.3; NA; 24.1; NA hr*µg/mL
Phase 2 N=195 Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents
HIV Infections
Primary: Number of Participants Who Experienced a Safety Endpoint of Interest Attributed to ATV — 1; 4; 0; 0 participants
N/A N=60 Heart Function in HIV-Negative Children Exposed to HIV and HAART
HIV Infections
Primary: Left Ventricular Mass Index — 67; 60 g/m2 — p=0.27
Phase 2 N=155 Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth
HIV Infections · H1N1 Influenza Virus
Primary: The Number of Participants Who Had at Least One Adverse Event (AE) — 113; 0; 7; 6 participants
Phase 2 N=43 Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs
HIV Infections
Primary: Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment. — 0.17; 0.1; 0.19 proportion of participants
Phase 2 N=57 The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
HIV Infections
Primary: Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC — 17.7; 19.8; 15.1; 17.4 h*ug/mL
Phase 2 N=52 T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents
HIV Infections
Primary: Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343) — 56.1; 52.7; 3.07; 3.41 microgram hour per…
Phase 4 N=40 Dihydroartemisinin-Piperaquine in the Context of Antiretroviral Therapy
Drug-Drug Interaction · HIV Infection
Primary: AUC0-42day in 3-dose Study — 4.47; 14.9; 49.7; 14.6 hr.ug/mL
N/A N=704 Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy
Chronic HIV Infection
Primary: Number of Participants With Viral Suppression — 289; 283 participants — p=0.55
Phase 4 N=59 Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients
HIV, Pediatric
Primary: Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, and…
Phase 3 N=176 HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children
Malaria · HIV Infections
Primary: Incidence-density of Malaria Defined as the Number of Incident Episodes of Malaria Per Time at Risk. — 1.32; 2.25 Episodes/ Person-Yr at Risk — p=0.04
Phase 2 N=126 Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children
HIV Infections · Sexually Transmitted Diseases
Primary: Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) — 7.3; 6.7 percent of participants — p=1.00
Phase 3 N=298 Treatment Options for Protease Inhibitor-exposed Children
HIV/AIDS · HIV Infections
Primary: Viral Rebound — 0.284; 0.176 probability of viral rebound — p=<0.001
Phase 1 N=115 Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
HIV Infections
Primary: Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation — 2; 6; 3; 2 participants
Phase 3 N=99 Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients
HIV
Primary: Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block…
Phase 2 N=451 Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV
HIV Infections
Primary: Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study…
Phase 4 N=1,653 IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women
HIV Infection
Primary: Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death — 0.21; 0.31 New cases per 100 person - years…
Phase 2 N=12 Dual bNAb Treatment in Children
HIV Infection
Primary: Frequency of Treatment-associated Adverse Events (AEs) [Number of Participants With Treatment-associated Adverse Event(s) of Any Grade] — 4; 1; 19 Participants
N/A N=1,066 Adolescent Transition To Adult Care for HIV-infected Adolescents in Kenya
Adolescent Behavior · HIV · Transition
Primary: Transition Readiness Score Overall — 15.7; 13.9 score on a scale
Phase 2 N=40 Safety, Tolerance and Pharmacokinetics of Raltegravir-Containing Antiretroviral Therapy in Infants, Children Infected With HIV and TB
HIV Infections · Tuberculosis
Primary: Number of Participants Who Permanently Discontinued Treatment Due to Adverse Event(s) of Greater Than or Equal to Grade 3 Deemed at Least Possibly Related to Raltegravir…
Phase 3 N=1,735 Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
Disease Transmission, Vertical · Vertical Human Immunodeficiency Virus Transmission · HIV Infections
Primary: Infant HIV Infection Status — 24; 11; 12 participants — p=.046
Phase 3 N=41 Study To Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in Human Immunodeficiency Virus 1 (HIV-1) Infected Children and Adolescents Virologically Suppressed on a 2-Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (2-NRTI)-Containing Regimen
HIV-1
Primary: Pharmacokinetic (PK) Parameter (Cohort 1): AUCtau of Tenofovir Alafenamide (TAF) — 139.9; 200.6 h*ng/mL
N/A N=1,911 Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3)
Adolescent Behavior · Hiv
Primary: Proportion of Missed Visits — 406; 433 Scheduled visits — p=0.631