Current Clinical Trials




a) APV 20002
A 48 Week Phase II, Open-label, 2 cohort, Multi-centre study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of GW433908 andGW433908/RTV when administered to HIV-1 infected Protease Inhibitor (PI) Naïve and PI – experienced pediatric subjects aged 4weeks to < 2 years.
Duration: 17 March 2008 – continue
Sponsor: GlaxoSmithKline


b) BMS Prince I
A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted with Ritonavir (RTV) Liquid with Optimal an optimized NRTI Background Therapy, in HIV Infected Pediatric Patients Greater Than or Equal to 3 months to Less than 6 Years. (Pediatric Atazanavir International Clinical Evaluation: the PRINCE I study)
Duration: 1 February 2011 + ongoing
Sponsor: Bristol Myers Squibb


c) BMS – Prince II
A Prospective Single Arm, Open-label, International, Multicentre Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder boosted with Ritonavir (RTV) Liquid with an Optimized NRTI Background Therapy, in HIV Infected, Antiretroviral, Naive and Experienced Pedriatric Subjects Greater than or Equal to 3 Months to Less than 8 Years (Pediatric Atazanavir International Clinical Evaluation: the PRINCE II study)
Duration: 1 November 2011- still recruiting
Sponsor: Bristol Myers Squibb


d) BMS Prince III
Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety of Atazanavir (ATV) Capsule Boosted with Ritonavir (RTV) with an Optimized NRTI Background Therapy, in HIV Infected, Antiretroviral Naive and Experienced Pediatric Subjects Greater Than or Equal to 6 Years to Less Than 18 Years
Duration: 1February 2014 + ongoing
Sponsor: Bristol Myers Squibb


e) Gilead 236-0112 (QUAD Study)
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/ Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen(STR) in HIV- Infected Antiretroviral Treatment-Naive Adolescents Treatment-Naive Adolescents
Duration: July 2014
Sponsor: Gilead


f) Gilead 311-1269
A Phase 1/2, Open-Label, Multi-Cohort Switch Study to Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a 2-NRTI-Containing Regimen
Duration: July 2014
Sponsor: Gilead


g) Gilead 380-1471
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Virologically Suppressed Adolescents and Children
Duration: Jan 2016
Sponsor: Gilead


h) Medimmune
A Phase 1b/2a Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody with an Extended Half-Life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
Duration: July 2015
Sponsor: Medimmune


i) VPM
Phase II double-blind, randomized, controlled study to evaluate the safety and immunogenicity of VPM1002 in comparison with BCG in HIV-exposed and HIV-unexposed, BCG-naive new born infants
Duration: Aug 2015
Sponsor: VPM


j) RSV
A phase 3, Randomized, observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and safety of a Respiratory Syncytial Virus(RSV) F Nanoparticle Vaccine with Aluminum in Healthy Third –trimester Pregnant Women; and Safety and Efficacy of Maternally Transferred Antibodies in Preventing RSV Disease in their Infants.
Duration: Jan 2016
Sponsor: Tricillium


k) BMS
A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of BMS-663068 in Heavily Treatment Experienced Subjects Infected with Multi-drug Resistant HIV-1
Duration: Jan 2016
Sponsor: BMS


l) GSK
A Randomized 11b randomised, open- label study of the safety and efficacy of Dolutegravir or Efevirenz, each administered with two NRTIs in HIV-1- infected antiretroviral therapy-naïve adults starting treatment Rifampicin-sensitive tuberculosis.
Duration: Jan 2016
Sponsor: GSK


m) Novavax RSV-M-301
A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study To Determine The Immunogenicity And Safety Of A Respiratory Syncytial Virus (Rsv) F Nanoparticle Vaccine With Aluminum In Healthy Third-Trimester Pregnant Women; And Safety And Efficacy Of Maternally Transferred Antibodies In Preventing Rsv Disease In Their Infants
Duration: Jan 2016
Sponsor: Novavax


n) PENTA 20 – Odyssey
A randomised trial of dolutegravir (DTG)-based antiretroviral therapy vs. standard of care (SOC) in children with HIV infection starting first-line or switching to second-line ART.
Duration: Dec 2016
Sponsor: PENTA



Investigator initiated


a) R01 + R21
The effects of early versus delayed antiretroviral treatment on the short and long – term neurodevelopment outcome of HIV – Infected children.
Duration: September 2011
Sponsor: Massachusetts General Hospital


b) DNDi HIVPed001
The study is looking at the drug levels of anti HIV/TB in the blood of children that are co – infected with HIV and TB. It also looks at the safety and how children tolerate the anti HIV/TB drugs while they are on treatment. For the study children need to weigh between 3 kg and 15 kg.
Duration: January 2013 – 2014
Sponsor – DNDI


c) Collaborative HIV Paediatric Study (CHIPS) subanalysis
The study database is from a multicentre cohort study of all known HIV-infected children in the United Kingdom (UK). This subanalysis looks at the prevalence and risk factors for lipoatrophy and lipohypertrophy in this cohort over 12
Duration: March 2013 –
Sponsor – None


d) Non-infectious Chronic Diseases in Children on ART
This study aims to identify the most common and clinically relevant non-infectious chronic disease patterns (cardiovascular, metabolic, respiratory, renal and bone disease) in HIV-infected children on ART.
Duration: July 2013 –
Sponsor – Collaborative Initiative for Paediatric HIV Education and Research (CIPHER), Fogarty International Clinical Research Fellowship + The University of California San Diego Centre for AIDS Research


e) Lipoatrophy screening tool validation study
This study aims to validate the various simple anthropometric measurements to screen for pre-clinical lipoatrophy in children on ART, including biceps skin-fold thickness.
Duration: January 2013
Sponsor – GSK-Viiv Foundation Seed Fund


f) Intracellular concentrations of stavudine-triphosphate after administration of half-dose stavudine in children and adults Children on ART.

This study will will check whether the children have the same amount of stavudine inside their blood cells as the adults do when taking half the original standard dose. If they do then we can be confident that the low dose will fight HIV in children as well as it does in adults, allowing the recommended children’s dose to be reduced. Using a smaller dose of stavudine will substantially reduce the frequency and severity of side effects, making the drug much safer for children in the developing world to use.
Duration: January 2014 – December 2015
Sponsor – Bill & Melinda Gates Foundation Global Health Research Grant.


g) Reservoir
Latent reservoir characterization and correlations with neurocognitive functioning.
Duration: November 2014 – continue
Sponsor: NIH




a) P1106
Pharmacokinetic characteristics of antiretroviral and tuberculosis medicines in low birth weight infants.
Duration: Aug 2015 – continue
Sponsor: IMPAACT


b) P1070
P1070 is a study looking at using an antiretroviral called efavirenz in children less than 3 years of age. Efavirenz is a type of antiretroviral known as a non-nucleoside reverse transcription inhibitor (NNRTI). It is presently not registered for use in children < 3 years. This study will look at the correct dose needed in infants and children and will also look at the safety and efficacy of efavirenz.
It is also looking at giving efavirenz to children who need TB treatment in addition to ARVs. Inclusion age criteria: = 3 months to = 3 years.
Duration: 16 March 2010 – Dec 2015
Sponsor: IMPAACT


c) P1060
This is a study comparing the response to 2 ARV regimes of HIV infected infants who have and have not previously received a single dose of Nevirapine for the prevention of mother – to – child – transmission.
Duration: November 2008 – Dec 2016
Sponsor: IMPAACT


d) P1084
Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of the IMPAACT 1077 PROMISE Protocol (Promoting Maternal and Infant Survival Everywhere)
Duration: May 2011 – Dec 2016
Sponsor: IMPAACT


e) P1077
The 1077 protocol is designed to address in the integrated and comprehensive fashion 4 critical questions currently facing HIV infected pregnant and postpartum women and their infants.
Duration: May 2011 – Nov 2016
Sponsor: IMPAACT


f) P1113
Phase I/II, safety immunogenicity study of a recombinant protein tuberculosis vaccine (AERAS-404) IN BCG-primed infants
Duration: July 2013 – 2015
Sponsor: IMPAACT


g) P1104
Longitudinal Developmental and Neuropsychological Assessments of HIV-Infected participants of P1060 and HIV- Uninfected Controls
Duration: 25 October 2013 – Dec 2016
Sponsor: IMPAACT


h) P1026
Pharmacokinetic properties of antiretroviral drugs during pregnancy
Duration: July 2014 – continue
Sponsor: IMPAACT


i) P1101
Phase I/II dose finding study to determine the safety, tolerance, drug-drug interaction and pharmacokinetics of Raltegravir containing antiretroviral therapy (ART) regimen in ART-Naïve HIV-Infected and TB Co-infected children >3 years to < 12 years of age.
Duration: October 2014 – continue
Sponsor: IMPAACT


j) P1093
Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of GSK1349572, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents
Duration: July 2014 – continue
Sponsor: IMPAACT


k) P1078
A randomized double – blind placebo – controlled trial to evaluate the safety of immediate (antepartum – initiated) versus deferred (postpartum
– initiated) isonaized preventive therapy among HIV – infected woman in high TB incidence settings.
Duration: January 2015 – Sep 2017
Sponsor: IMPAACT


l) A5288
Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral failure (MULTI-OCTAVE)
Duration: June 2015 – May 2017
Sponsor: ACTG


m) P1115
Very early intensive treatment of HIV- infected infants to achieve HIV remission: A Phase I/II proof of concept study
Duration: Nov 2015 – continue
Sponsor: IMPAACT


n) P1110
A Phase I Trial To Evaluate The Safety And Pharmacokinetics Of Raltegravir In HIV-1-Exposed Neonates At High Risk Of Acquiring HIV-1 Infection
Duration: Oct 2016 – continue
Sponsor: IMPAACT


o) P1112
Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous (SC) VRC01, a Potent Anti-HIV Neutralizing Monoclonal Antibody, in HIV-1-Exposed Infants.
Duration: January 2016 – continue
Sponsor: IMPAACT


p) IMPAACT 2010 – Vested
Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants.
Duration: December 2017 – continue
Sponsor: IMPAACT


q) A5243
Plan for Obtaining Human Biological Samples at Non-US Clinical Research Sites for Currently Unspecified Genetic Analyses
Duration: June 2017 – continue
Sponsor: ACTG


r) A5263
Randomized Comparison of Three Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings.
Duration: Jan 2017 – continue
Sponsor: ACTG


s) A5264
A Randomized Evaluation of Antiretroviral Therapy Alone or with Delayed Chemotherapy versus Antiretroviral Therapy with Immediate Adjunctive Chemotherapy for Treatment of Limited Stage AIDS-KS in Resource-Limited Settings (REACT-KS).
Duration: Jan 2017 – continue
Sponsor: ACTG


t) A5278
Pharmacology Substudies of A5263 and A5264
Duration: Jan 2017 – continue
Sponsor: ACTG


u) A5332 (Reprieve)
Randomized Trial to Prevent Vascular Events in HIV – REPRIEVE (A5332).
Duration: Dec 2016 – continue
Sponsor: ACTG


v) A5349
Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial
Duration: Dec 2016 – continue
Sponsor: ACTG


w) A5354
Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses
Duration: Dec 2017 – continue
Sponsor: ACTG





© 2003-2024 FAMCRU All Rights Reserved I Faculty of Health Sciences