NCT00791700 is a Phase 2 clinical trial of Maraviroc in Human Immunodeficiency Virus, sponsored by ViiV Healthcare.

Who is sponsoring NCT00791700?

NCT00791700 is sponsored by ViiV Healthcare.

What drugs are being tested in NCT00791700?

Interventions in NCT00791700: Maraviroc.

What condition does NCT00791700 study?

NCT00791700 studies Human Immunodeficiency Virus.

Is NCT00791700 still recruiting?

NCT00791700 is currently status unknown. Last updated 28 April 2020.

Are results published for NCT00791700?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-04-28 · How we verify

NCT00791700

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children

Status unknown Phase 2 Results posted Last updated 28 April 2020

What this trial tests

Phase 2 trial testing Maraviroc in Human Immunodeficiency Virus in 103 participants. Status unknown.

Timeline

22 April 2009

Primary endpoint
14 April 2015

30 June 2023

Quick facts

Lead sponsor	ViiV Healthcare
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	103
Start date	22 April 2009
Primary completion	14 April 2015
Estimated completion	30 June 2023
Sites	41 locations across Italy, South Africa, Mexico, Puerto Rico, Thailand, Portugal, Spain, United States

Drugs / interventions tested

Maraviroc (MARAVIROC) — full drug profile →

Conditions studied

Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →

Sponsor

ViiV Healthcare — full company profile →

Who can join

Adults 2 to 18, any sex, with Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) Primary · Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)

Cavg: calculated as area under the curve divided by a dosing interval of 12 hours. Cmin: directly observed plasma concentration prior to the next dose. Geometric Coefficient of Variation is defined as the geometric standard deviation to the power of the reciprocal of the geometric mean.

Cavg-Week2

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	237.34	± 63
>=6 - <12 Years of Age, MVC Tablet Formulation	260.65	± 43
>=6 - <12 Years of Age, MVC Liquid Formulation	264.45	± 62
>=12 - <18 Years of Age, MVC Tablet Formulation	239.85	± 67

Cavg-Week 48

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	163.73	± 146
>=6 - <12 Years of Age, MVC Tablet Formulation	289.69	± 50
>=6 - <12 Years of Age, MVC Liquid Formulation	168.62	± 117
>=12 - <18 Years of Age, MVC Tablet Formulation	199.12	± 78

Cmax-Week2

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	581.47	± 69
>=6 - <12 Years of Age, MVC Tablet Formulation	546.80	± 51
>=6 - <12 Years of Age, MVC Liquid Formulation	444.37	± 61
>=12 - <18 Years of Age, MVC Tablet Formulation	530.80	± 62

Cmax-Week 48

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	334.68	± 156
>=6 - <12 Years of Age, MVC Tablet Formulation	593.68	± 25
>=6 - <12 Years of Age, MVC Liquid Formulation	284.96	± 128
>=12 - <18 Years of Age, MVC Tablet Formulation	423.32	± 48

Cmin-Week2

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	18.97	± 202208
>=6 - <12 Years of Age, MVC Tablet Formulation	100.02	± 39
>=6 - <12 Years of Age, MVC Liquid Formulation	115.84	± 90
>=12 - <18 Years of Age, MVC Tablet Formulation	56.17	± 145

Cmin-Week 48

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	48.11	± 180
>=6 - <12 Years of Age, MVC Tablet Formulation	82.21	± 120
>=6 - <12 Years of Age, MVC Liquid Formulation	60.03	± 245
>=12 - <18 Years of Age, MVC Tablet Formulation	66.51	± 140

Area Under the Curve at Steady State (AUCtau) Primary · Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)

AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 12 hours.

AUCtau - Week 2

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	2848.1	± 63
>=6 - <12 Years of Age, MVC Tablet Formulation	3127.7	± 43
>=6 - <12 Years of Age, MVC Liquid Formulation	3173.4	± 62
>=12 - <18 Years of Age, MVC Tablet Formulation	2878.2	± 67

AUCtau - Week 48

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	1964.7	± 146
>=6 - <12 Years of Age, MVC Tablet Formulation	3476.3	± 50
>=6 - <12 Years of Age, MVC Liquid Formulation	2023.5	± 117
>=12 - <18 Years of Age, MVC Tablet Formulation	2389.4	± 78

Time to Reach Maximum Plasma Concentration (Tmax) Primary · Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)

Tmax - Week 2

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	2.000	0.97 – 6.00
>=6 - <12 Years of Age, MVC Tablet Formulation	4.000	0.75 – 6.00
>=6 - <12 Years of Age, MVC Liquid Formulation	2.000	1.00 – 4.00
>=12 - <18 Years of Age, MVC Tablet Formulation	2.000	1.00 – 4.00

Tmax - Week 48

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	2.000	0.00 – 6.03
>=6 - <12 Years of Age, MVC Tablet Formulation	2.000	1.00 – 8.00
>=6 - <12 Years of Age, MVC Liquid Formulation	3.000	0.00 – 6.00
>=12 - <18 Years of Age, MVC Tablet Formulation	2.000	1.00 – 4.00

Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) Primary · Baseline up to 5 years

Incidence is reported in terms of number of events of AEs. The investigator used the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs as follows: Grade 1= Symptoms causing no or minimal interference with usual social and functional activities; Grade 2= Symptoms causing greater than minimal interference with usual social and functional activities; Grade 3= Symptoms causing inability to perform usual social and functional activities; Grade 4= Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent

Gastrointestinal disorders - Vomiting

Group	Value	95% CI
Cohort 1 (Grade 3)	1
Cohort 1 (Grade 4)	0
Cohort 2 (Grade 3)	1
Cohort 2 (Grade 4)	0
Cohort 3 (Grade 3)	0
Cohort 3 (Grade 4)	0
Cohort 4 (Grade 3)	0
Cohort 4 (Grade 4)	0

Hepat. disorders - Drug-induced liver injury

Group	Value	95% CI
Cohort 1 (Grade 3)	0
Cohort 1 (Grade 4)	0
Cohort 2 (Grade 3)	0
Cohort 2 (Grade 4)	0
Cohort 3 (Grade 3)	0
Cohort 3 (Grade 4)	0
Cohort 4 (Grade 3)	0
Cohort 4 (Grade 4)	1

Infections and infestations - H1N1 influenza

Group	Value	95% CI
Cohort 1 (Grade 3)	0
Cohort 1 (Grade 4)	0
Cohort 2 (Grade 3)	0
Cohort 2 (Grade 4)	0
Cohort 3 (Grade 3)	0
Cohort 3 (Grade 4)	0
Cohort 4 (Grade 3)	1
Cohort 4 (Grade 4)	0

Infections and infestations - Pneumonia

Group	Value	95% CI
Cohort 1 (Grade 3)	0
Cohort 1 (Grade 4)	0
Cohort 2 (Grade 3)	0
Cohort 2 (Grade 4)	0
Cohort 3 (Grade 3)	1
Cohort 3 (Grade 4)	0
Cohort 4 (Grade 3)	1
Cohort 4 (Grade 4)	0

Investigations - Lipase increased

Group	Value	95% CI
Cohort 1 (Grade 3)	0
Cohort 1 (Grade 4)	1
Cohort 2 (Grade 3)	0
Cohort 2 (Grade 4)	0
Cohort 3 (Grade 3)	0
Cohort 3 (Grade 4)	0
Cohort 4 (Grade 3)	0
Cohort 4 (Grade 4)	0

Pyschiatric disorder - Bipolar disorder

Group	Value	95% CI
Cohort 1 (Grade 3)	0
Cohort 1 (Grade 4)	0
Cohort 2 (Grade 3)	1
Cohort 2 (Grade 4)	0
Cohort 3 (Grade 3)	0
Cohort 3 (Grade 4)	0
Cohort 4 (Grade 3)	0
Cohort 4 (Grade 4)	0

Gastrointestinal disorders - Gastritis

Group	Value	95% CI
Cohort 1 (Grade 3)	0
Cohort 1 (Grade 4)	0
Cohort 2 (Grade 3)	1
Cohort 2 (Grade 4)	0
Cohort 3 (Grade 3)	0
Cohort 3 (Grade 4)	0
Cohort 4 (Grade 3)	0
Cohort 4 (Grade 4)	0

Investigations - Hepatic enzyme abnormal

Group	Value	95% CI
Cohort 1 (Grade 3)	0
Cohort 1 (Grade 4)	0
Cohort 2 (Grade 3)	1
Cohort 2 (Grade 4)	0
Cohort 3 (Grade 3)	0
Cohort 3 (Grade 4)	0
Cohort 4 (Grade 3)	0
Cohort 4 (Grade 4)	0

Treatment Discontinuation: Secondary Reasons- Serious Adverse Event (SAE) Related to Study Drug Primary · Baseline up to 5 years

The primary reason for a participant discontinuing from study drug or the clinical study was recorded in the source documents as well as the case report form. A discontinuation had to be reported immediately to the study medical monitor or his/her designated representative if it was due to an SAE and was considered as a secondary reason.

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	0
>=6 - <12 Years of Age, MVC Tablet Formulation	0
>=6 - <12 Years of Age, MVC Liquid Formulation	0
>=12 - <18 Years of Age, MVC Tablet Formulation	0

Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach Secondary · Week 24 and Week 48 post-treatment

The proportion of participants who achieved HIV-1 RNA \<400 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.

Week 24

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	68.8
>=6 - <12 Years of Age, MVC Tablet Formulation	90.3
>=6 - <12 Years of Age, MVC Liquid Formulation	69.2
>=12 - <18 Years of Age, MVC Tablet Formulation	62.8

Week 48

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	75.0
>=6 - <12 Years of Age, MVC Tablet Formulation	77.4
>=6 - <12 Years of Age, MVC Liquid Formulation	69.2
>=12 - <18 Years of Age, MVC Tablet Formulation	51.2

Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach Secondary · Week 24 and Week 48 post-treatment

The proportion of participants who achieved HIV-1 RNA \<48 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.

Week 24

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	18.75
>=6 - <12 Years of Age, MVC Tablet Formulation	64.5
>=6 - <12 Years of Age, MVC Liquid Formulation	61.5
>=12 - <18 Years of Age, MVC Tablet Formulation	48.8

Week 48

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	50.0
>=6 - <12 Years of Age, MVC Tablet Formulation	54.8
>=6 - <12 Years of Age, MVC Liquid Formulation	53.8
>=12 - <18 Years of Age, MVC Tablet Formulation	39.5

Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach Secondary · Week 24 and Week 48 post-treatment

Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels \> lower limit of quantification (LLOQ) . This referred to as \[non-completer = failure; NC=F\] or \[missing, discontinuation = failure; MD=F\].

Week 24

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	62.5	38.8 – 86.2
>=6 - <12 Years of Age, MVC Tablet Formulation	87.10	75.3 – 98.9
>=6 - <12 Years of Age, MVC Liquid Formulation	69.2	44.1 – 94.3
>=12 - <18 Years of Age, MVC Tablet Formulation	62.8	48.3 – 77.2

Week 48

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	75.0	53.8 – 96.2
>=6 - <12 Years of Age, MVC Tablet Formulation	74.2	58.8 – 89.6
>=6 - <12 Years of Age, MVC Liquid Formulation	69.2	44.1 – 94.3
>=12 - <18 Years of Age, MVC Tablet Formulation	51.2	36.2 – 66.1

Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach Secondary · Week 24 and Week 48 post-treatment

Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels \> lower limit of quantification (LLOQ) . This referred as \[non-completer = failure; NC=F\] or \[missing, discontinuation = failure; MD=F\].

Week 24

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	18.8	0.0 – 37.9
>=6 - <12 Years of Age, MVC Tablet Formulation	64.5	47.7 – 81.4
>=6 - <12 Years of Age, MVC Liquid Formulation	61.5	35.1 – 89.0
>=12 - <18 Years of Age, MVC Tablet Formulation	48.8	33.9 – 63.8

Week 48

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	50.0	25.5 – 74.5
>=6 - <12 Years of Age, MVC Tablet Formulation	54.8	34.0 – 69.2
>=6 - <12 Years of Age, MVC Liquid Formulation	53.8	35.1 – 89.0
>=12 - <18 Years of Age, MVC Tablet Formulation	39.5	24.9 – 54.2

Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48 Secondary · Week 48

TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm.

<400 copies/mL; TLOVR Responder

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	62.5
>=6 - <12 Years of Age, MVC Tablet Formulation	74.2
>=6 - <12 Years of Age, MVC Liquid Formulation	69.2
>=12 - <18 Years of Age, MVC Tablet Formulation	48.8

<48 copies/mL; TLOVR Responder

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	43.8
>=6 - <12 Years of Age, MVC Tablet Formulation	54.8
>=6 - <12 Years of Age, MVC Liquid Formulation	46.2
>=12 - <18 Years of Age, MVC Tablet Formulation	44.2

Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48 Secondary · Baseline to Week 24, Week 48 post-treatment

Percentage of participants with at least a 1.0 log10 reduction in HIV-1 RNA from baseline to Week 24 and Week 48 were tabulated.

Baseline to Week 24

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	92.3	77.8 – 106.8
>=6 - <12 Years of Age, MVC Tablet Formulation	100.0	100.0 – 100.0
>=6 - <12 Years of Age, MVC Liquid Formulation	100.0	100.0 – 100.0
>=12 - <18 Years of Age, MVC Tablet Formulation	93.1	83.9 – 102.3

Baseline to Week 48

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	100.0	100.0 – 100.0
>=6 - <12 Years of Age, MVC Tablet Formulation	96.2	88.8 – 103.6
>=6 - <12 Years of Age, MVC Liquid Formulation	100.0	100.0 – 100.0
>=12 - <18 Years of Age, MVC Tablet Formulation	88.0	75.3 – 100.7

Change From Baseline in HIV-1 RNA (Original) Secondary · Baseline, Week 24, Week 48 post-treatment

Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification \[LLOQ\] \<48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA \>1000 copies/ml was used to determine eligibility for the study.

Change from Baseline - Original - Week 24

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	-271974.6	± 391843.59
>=6 - <12 Years of Age, MVC Tablet Formulation	-38764.0	± 63688.93
>=6 - <12 Years of Age, MVC Liquid Formulation	-58081.0	± 79720.33
>=12 - <18 Years of Age, MVC Tablet Formulation	-57325.7	± 172108.62

Change from Baseline - Original - Week 48

Group	Value	95% CI
>=2 - <6 Years of Age, MVC Liquid Formulation	-267834.2	± 378896.88
>=6 - <12 Years of Age, MVC Tablet Formulation	-34787.7	± 60222.60
>=6 - <12 Years of Age, MVC Liquid Formulation	-56351.7	± 76231.03
>=12 - <18 Years of Age, MVC Tablet Formulation	-55321.1	± 173840.55

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to 5 years. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

>=2 - <6 Years of Age, MVC Liquid Formulation

Serious: 5/16 (31%)

Deaths: 0/16

>=6 - <12 Years of Age, MVC Tablet Formulation

Serious: 5/31 (16%)

Deaths: 0/31

>=6 - <12 Years of Age, MVC Liquid Formulation

Serious: 3/13 (23%)

Deaths: 0/13

>=12 - <18 Years of Age, MVC Tablet Formulation

Serious: 10/43 (23%)

Deaths: 1/43

Serious adverse events (25 terms)

Reaction	System	>=2 - <6 Years of Age, MVC…	>=6 - <12 Years of Age, MV…	>=6 - <12 Years of Age, MV…	>=12 - <18 Years of Age, M…
Pneumonia	Infections and infestations	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Gastric fistula	Gastrointestinal disorders	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Drug-induced liver injury	Hepatobiliary disorders	—	—	—	—
Abscess oral	Infections and infestations	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—
H1N1 influenza	Infections and infestations	—	—	—	—
Pelvic inflammatory disease	Infections and infestations	—	—	—	—
Pulmonary tuberculosis	Infections and infestations	—	—	—	—
Tooth abscess	Infections and infestations	—	—	—	—
Viral infection	Infections and infestations	—	—	—	—
Transaminases increased	Investigations	—	—	—	—
Osteopenia	Musculoskeletal and connective tissue disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Tendon disorder	Musculoskeletal and connective tissue disorders	—	—	—	—
Bipolar disorder	Psychiatric disorders	—	—	—	—
Hyperventilation	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Prurigo	Skin and subcutaneous tissue disorders	—	—	—	—
Otorrhoea	Ear and labyrinth disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Meningitis	Infections and infestations	—	—	—	—

Other adverse events (204 terms — click to expand)

Reaction	System	>=2 - <6 Years of Age, MVC…	>=6 - <12 Years of Age, MV…	>=6 - <12 Years of Age, MV…	>=12 - <18 Years of Age, M…
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Conjunctivitis allergic	Eye disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—	—
Abscess	Infections and infestations	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—
Lice infestation	Infections and infestations	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—
Otitis externa	Infections and infestations	—	—	—	—
Otitis media acute	Infections and infestations	—	—	—	—
Otitis media chronic	Infections and infestations	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—
Sinobronchitis	Infections and infestations	—	—	—	—
Tinea capitis	Infections and infestations	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—
Wound infection	Infections and infestations	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—
Weight increased	Investigations	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—

Most-reported serious reactions: Pneumonia, Anaemia, Gastric fistula, Gastritis, Vomiting, Drug-induced liver injury, Abscess oral, Cellulitis.

Data from ClinicalTrials.gov NCT00791700 adverse events section.

Sponsor's own description

The primary purpose of this study is to determine the pharmacokinetic properties (what the body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1 infected children and adolescents. This study will also determine whether maraviroc is safe to use in children and adolescents.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Paediatric European Network for Treatment of AIDS (PENTA) guidelines for treatment of paediatric HIV-1 infection 2015: optimizing health in preparation for adult life.
Bamford A, Turkova A, Lyall H, Foster C, et al · · 2018 · cited 60× · PMID 25649230 · DOI 10.1111/hiv.12217
Pharmacokinetics, Safety and Efficacy of Maraviroc in Treatment-experienced Pediatric Patients Infected With CCR5-Tropic HIV-1.
Giaquinto C, Mawela MP, Chokephaibulkit K, Negra MD, et al · · 2018 · cited 8× · PMID 29023357 · DOI 10.1097/inf.0000000000001808
HIV-1 co-receptor tropism and disease progression in children and young adults with perinatally acquired HIV-1 infection. The HICCUP Study.
Foster C, Kaye S, Smith C, Mackie NE. · · 2015 · cited 3× · PMID 27482409 · DOI 10.1016/s2055-6640(20)30505-7

Verify or expand the search:

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ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00791700 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ViiV Healthcare
Last refreshed: 28 April 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00791700.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00791700

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (25 terms)

Sponsor's own description

Publications & conference data

Related trials

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Other recruiting trials for Human Immunodeficiency Virus

Other ViiV Healthcare trials

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