Clinical trials: Pediatric HIV Infection
HIV Infections
Dolutegravir Pediatric Liquid Formulation Study
This is an open-label, single-center, single dose, non-randomized, sequential, fixed-sequence study, which will evaluate pharmacokinetics (PK) of dolutegravir (DTG) in healthy adult subjects.
- Trial name
- NCT03921723
- Testing
- Dolutegravir dispersible tablet, Dolutegravir oral suspension, Dolutegravir oral solution
- Where
- United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Clinical Sensitivity of Clearview Rapid Tests in 12-17 y/o Pediatric Population
This study is to establish the clinical sensitivity of the Chembio Diagnostics Systems, Inc. Clearview COMPLETE HIV 1/2 Assay and Clearview HIV 1/2 Stat-Pak Assay (Clearview HIV tests) in pediatric subjects who are between 12 and…
- Trial name
- NCT00567749
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Chembio Diagnostic Systems, Inc.
HIV Infections
Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV
The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.
- Trial name
- NCT00017992
- Testing
- Lopinavir/Ritonavir, Emtricitabine, Stavudine
- Where
- 14 sites in United States, Argentina and 4 more
- Volunteers
- 100 people
- Sponsor
- Triangle Pharmaceuticals
HIV Infections
An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease
To provide access to Viramune and to evaluate the tolerance and safety of Viramune in patients with progressive, symptomatic HIV disease who failed or are intolerant to currently approved treatment for HIV-1 infection and who are…
- Trial name
- NCT00002166
- Testing
- Nevirapine
- Where
- United States
- Sponsor
- Boehringer Ingelheim
Pharmacokinetics, Bioavailability
TMC278-TiDP38-C145: A Bioavailability Study in Healthy Adult Volunteers to Evaluate 3 Pediatric Formulations of TMC278 (a Solution, a Suspension, and Granules) Compared to an Adult Tablet Formulation
The purpose of this study is to evaluate how much and how fast a single, oral, daily 25 mg dose of TMC278 is absorbed into the body when administered as a solution, suspension, granules, or a tablet.
- Conditions
- Pharmacokinetics, Bioavailability, HIV-1
- Trial name
- NCT00812292
- Testing
- TMC278
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV-1
A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years
The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen…
- Trial name
- NCT00799864
- Testing
- Rilpivirine, Zidovudine, Abacavir
- Where
- 17 sites in United States, India and 6 more
- Volunteers
- 54 people
- Sponsor
- Janssen Sciences Ireland UC
HIV Infections, Chickenpox
A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success With or Who Cannot Take Other Treatments for VZV
To provide oral sorivudine ( BV-araU ) to pediatric HIV-infected patients with varicella-zoster viral disease who have failed or are intolerant of alternative therapy.
- Trial name
- NCT00002358
- Testing
- Sorivudine
- Where
- United States
- Sponsor
- Bristol-Myers Squibb
HIV Infections
An Open-Label Safety Program for the Use of Zalcitabine (Dideoxycytidine; ddC) in Pediatric Patients With Symptomatic HIV Infection Who Have Failed or Are Intolerant to AZT Monotherapy, or Who Have Completed Other ddC Protocols, or Are Ineligible for Other Ongoing Clinical Studies
To allow, on a compassionate use basis, zalcitabine (ddC) for pediatric patients with symptomatic HIV disease who have failed treatment or who are intolerant to zidovudine (AZT), or who have completed other ddC protocols, or who…
- Trial name
- NCT00002118
- Testing
- Zalcitabine
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- Hoffmann-La Roche
Human Immunodeficiency Virus Type 1
A Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Who Participated in Rilpivirine Pediatric Studies
The purpose of this study is to provide continued access to rilpivirine (RPV) for participants who were treated with RPV in a clinical development pediatric study with rilpivirine and who, at the time of roll-over, experience and…
- Trial name
- NCT02494986
- Testing
- Rilpivirine
- Where
- 8 sites in Portugal, South Africa and 3 more
- Volunteers
- 48 people
- Sponsor
- Janssen Sciences Ireland UC
Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV
The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in…
- Trial name
- NCT02016924
- Testing
- ATV, DRV, Cobicistat
- Where
- 23 sites in United States, Argentina and 5 more
- Volunteers
- 133 people
- Sponsor
- Gilead Sciences
HIV
Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients
The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients…
- Trial name
- PRINCE2 (NCT01335698)
- Testing
- Atazanavir Sulphate, Ritonavir
- Where
- 32 sites in United States, Argentina and 9 more
- Volunteers
- 160 people
- Sponsor
- Bristol-Myers Squibb
HIV-1
Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets
The primary purpose of this study is to assess the ability to swallow the scored film-coated darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablet, irrespective of the mode of…
- Trial name
- NCT04006704
- Where
- 8 sites in United States, Spain
- Volunteers
- 25 people
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
HIV Infections
Trial to Evaluate Steady State Pharmacokinetic Parameters, Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric Patients
Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and nevirapine 4 or 7 mg/kg after 4 weeks, and efficacy and safety of the dosing when administered for 48 weeks in antiretroviral drug naïve…
- Trial name
- NCT00273975
- Testing
- Nevirapine, Lamivudine, Zidovudine
- Where
- 4 sites in South Africa
- Volunteers
- 123 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
The purpose of this study is to see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.
- Trial name
- NCT00002219
- Testing
- Nelfinavir mesylate, Levocarnitine, Adefovir dipivoxil
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ≥35 kg (MK-8591A-028)
This is a phase 2, single-group, multi-site, open-label study of an islatravir/doravirine (ISL/DOR, MK-8591A) fixed dose combination (FDC) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric…
- Trial name
- NCT04295772
- Testing
- DOR/ISL
- Where
- 17 sites in United States, Italy and 3 more
- Volunteers
- 42 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1-infection
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and…
- Trial name
- NCT06337032
- Testing
- F/TAF (High Dose Tablet), F/TAF (Low Dose Tablet), F/TAF (Lowest Dose Tablet)
- Where
- 15 sites in Argentina, Panama and 4 more
- Volunteers
- 350 people
- Sponsor
- Gilead Sciences
Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants
The primary objectives of this study are to evaluate the safety, tolerability and steady-state PK and confirm the dose of EVG/r in HIV-1 infected, antiretroviral treatment-experienced children 4 weeks to <18 years of age.
- Trial name
- NCT01923311
- Testing
- EVG, Background regimen
- Where
- 11 sites in United States, Italy and 4 more
- Volunteers
- 31 people
- Sponsor
- Gilead Sciences
Infection, Human Immunodeficiency Virus I
48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection
This is a 48-week study to collect information on the safety and activity of an investigational medicine in patients, ages 2 to 18 years old, with HIV infection .
- Trial name
- NCT00089583
- Testing
- LEXIVA (GW433908), Ritonavir
- Where
- 39 sites in United States, Belgium and 5 more
- Volunteers
- 110 people
- Sponsor
- ViiV Healthcare
HIV, Pediatric
Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients
The purpose of this study is to collect safety clinical data in HIV-infected pediatric patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are receiving atazanavir capsule boosted with ritonavir and…
- Trial name
- NCT01691794
- Testing
- Atazanavir, Ritonavir
- Where
- 27 sites in United States, Argentina and 6 more
- Volunteers
- 108 people
- Sponsor
- Bristol-Myers Squibb
HIV in Adults
Taste Properties of Atazanavir and Cobicistat
The primary objective is to assess the taste properties of atazanavir (ATV) and cobicistat (COBI) alone and in combination as well as oral test formulations containing both ATV and COBI.
- Trial name
- NCT02307656
- Testing
- Atazanavir, Cobicistat, Active Pharmaceutical Ingredient
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb