Clinical trials: Pediatric HIV Infection
Mycobacterium Avium-intracellulare Infection, HIV Infections
The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS
To evaluate three doses of clarithromycin in children with AIDS and Mycobacterium avium complex (MAC) infection who are receiving concurrent antiretroviral therapy.
- Trial name
- NCT00000971
- Testing
- Clarithromycin, Zidovudine, Didanosine
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Abbott
HIV Infections
Pediatric Expanded Access Program-Oral Solution (0831-908)
Monitor the safety and tolerability of efavirenz oral solution in combination with Antiretroviral Therapy for the treatment of patients age 3 to 16 years who have failed therapy or who are intolerant to their current therapy.
- Trial name
- NCT00543530
- Testing
- MK0831
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide…
- Trial name
- NCT00076999
- Testing
- TPV oral solution, RTV oral solution
- Where
- 30 sites in United States, Argentina and 8 more
- Volunteers
- 115 people
- Sponsor
- Boehringer Ingelheim
Infection, Human Immunodeficiency Virus, HIV Infections
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years…
- Trial name
- NCT00071760
- Testing
- GW433908, ritonavir
- Where
- 15 sites in United States, Argentina and 5 more
- Volunteers
- 59 people
- Sponsor
- ViiV Healthcare
Pneumonia, Pneumocystis Carinii, HIV Infections
A Study of Trimetrexate Plus Leucovorin in Children With Pneumocystis Carinii Pneumonia
To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in pediatric patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening…
- Trial name
- NCT00002317
- Testing
- Trimetrexate glucuronate, Leucovorin calcium
- Where
- United States
- Sponsor
- U.S. Bioscience
HIV Infections
A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation
This study will assess the relative bioavailability of the CAB DT formulation relative to that of the CAB IR formulation and to assess the effect of food on the CAB DT formulation.
- Trial name
- NCT05776108
- Testing
- Cabotegravir IR Formulation (reference), Cabotegravir DT Formulation (test 1), Cabotegravir DT Formulation (test 2)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus
Bioavailability Study of a Dolutegravir Dispersible Tablet and Effect of Different Types of Water on the Dispersible Tablet in Healthy Volunteers
Dolutegravir (DTG) is an HIV-1 integrase inhibitor approved in the United States, Canada, Australia and EU. A dispersible tablet has been developed for pediatric use as an alternative to the granule formulation, already in…
- Trial name
- NCT02185300
- Testing
- Dolutegravir Pediatric Granules, Dolutegravir Dispersible Tablet
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants
This study will assess the effect of food on the pharmacokinetics (PK) of pediatric formulations of TRIUMEQ (dolutegravir [DTG] 5 milligrams [mg]/abacavir [ABC] 60 mg/lamivudine [3TC] 30 mg) dispersible tablets and DOVATO (DTG 5…
- Trial name
- NCT04827134
- Testing
- TRIUMEQ, DOVATO
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV-1, HIV Infection
DOR/ISL in Pediatric Participants With HIV-1, <18 Years of Age and ≥ 35 kg
This is a phase 2 study of the pharmacokinetics, safety, and efficacy of oral doravirine/islatravir (100 mg/0.25 mg) [MK-8591A] in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection who are…
- Trial name
- NCT07862569
- Testing
- DOR/ISL
- Volunteers
- 45 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children
To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in combination with nelfinavir and nucleoside…
- Trial name
- NCT00002380
- Testing
- Nelfinavir mesylate, Saquinavir
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children
The primary purpose of this study is to find the dose of Efavirenz for young children. The safety and how the medication is tolerated will also be studied.
- Trial name
- NCT00364793
- Testing
- Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)
- Where
- 17 sites in Argentina, Colombia and 4 more
- Volunteers
- 56 people
- Sponsor
- Bristol-Myers Squibb
HIV Infections
An Open-Label Study of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects
To obtain safety and efficacy data for antiretroviral regimens containing emtricitabine in HIV-1 infected pediatric subjects. To determine emtricitabine concentrations in HIV-1 infected pediatric subjects and, if necessary, to…
- Trial name
- NCT00642291
- Testing
- Emtricitabine
- Where
- 2 sites in Romania
- Volunteers
- 16 people
- Sponsor
- Gilead Sciences
HIV Infections
The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used With and Without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs
To compare the safety, tolerance, durability of the viral load response and the antiviral activity of the 1592U89/zidovudine(ZDV)/lamivudine (3TC) regimen vs. ZDV/3TC regimen.
- Trial name
- NCT00002391
- Testing
- Abacavir sulfate, Lamivudine, Zidovudine
- Where
- 30 sites in United States
- Sponsor
- Glaxo Wellcome
HIV/AIDS
REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
The primary objective is to compare \& evaluate between the treatment groups the changes in decline/reduction of HIV viral load \& increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune…
- Trial name
- NCT02291809
- Testing
- REMUNE
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Immune Response BioPharma, Inc.
HIV Infections
To Assess the Relative Bioavailability (BA) of TRIUMEQ® and Dolutegravir and Lamivudine (DTG/3TC) Pediatric Dispersible Tablet Formulations in Healthy Volunteers
This is a 2-part, single-dose, open label, randomized 3-way cross-over study to compare BA of pediatric study drugs TRIUMEQ and (DTG/3TC) in healthy volunteers under fasted conditions. Study will be conducted in 2-parts.
- Trial name
- NCT03441984
- Testing
- Treatment A, Treatment B, Treatment C
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Infections, Human Immunodeficiency Virus and Herpesviridae
Relative Bioavailability Study of a Pediatric Granule Formulation of Dolutegravir
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor currently in Phase 3 clinical trials for the treatment of human immunodeficiency virus (HIV) infection.
- Trial name
- NCT01382238
- Testing
- Dolutegravir 50 mg tablet, Dolutegravir 50 mg oral granules
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus
Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet
This is an open-label, randomized, crossover study in healthy adult subjects with 5 treatment groups over 5 dosing periods. This study will evaluate pharmacokinetic parameters and relative bioavailability of a dispersible…
- Trial name
- NCT02893488
- Testing
- DTG/ABC/3TC FDC DISPERSIBLE TABLET, EPZICOM (ABC/3TC), TIVICAY (DTG)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV)
The purpose of this study is to determine whether atazanavir powder combined with ritonavir is safe and well tolerated and produces appropriate drug exposure in children ≥3 months to <6 years of age.
- Trial name
- PRINCE1 (NCT01099579)
- Testing
- Atazanavir powder, Ritonavir oral solution, Atazanavir capsules
- Where
- 18 sites in Brazil, Chile and 4 more
- Volunteers
- 82 people
- Sponsor
- Bristol-Myers Squibb
HIV Infections
A Study of 1592U89 in HIV-Infected Children
The purpose of this study is to see if it is safe to give 1592U89 to children (aged 6 months until 14th birthday) with advanced HIV infection who have few treatment options available.
- Trial name
- NCT00002197
- Testing
- Abacavir sulfate
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Glaxo Wellcome
HIV Infection
A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years
This is a 48-week study to collect additional information on the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy) including FDA approved HIV drugs in HIV-infected…
- Trial name
- NCT00040664
- Testing
- ritonavir, fosamprenavir
- Where
- 42 sites in United States, Canada and 5 more
- Volunteers
- 69 people
- Sponsor
- ViiV Healthcare