Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Maraviroc · 14 trials · 9 indications
AEs: any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was congenital anomaly. Grade 3: Events that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4: Events which were unacceptable and intolerable or which were irreversible or caused participant to be in imminent danger of death.
Grade 3 or severe events included those that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 or very severe events included those that were unacceptable and intolerable or which were irreversible or caused the participant to be in imminent danger of death.
Number of participants with AIDS-related infections based on investigator classification guided by a predefined list of clinical Category C AEs per Center for Disease Control (CDC) HIV Classification System.
Pre-defined criteria based on upper limit normal (ULN) and lower limit normal (LLN) were established for each laboratory test to define the values that would be identified as laboratory test abnormality.
AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE.
Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted participants usual daily activity and traditionally required systemic drug therapy or other treatment.
Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the participant to be in imminent danger of death.
Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug.
Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.
Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.
Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.
Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.
Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV).
Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV).
Amprenavir (APV) is the active ingredient/ metabolite of Fosamprenavir (FPV). MVC minimum concentration (Cmin), maximum concentration (Cmax), and area under the plasma concentration-time curve (AUC), as determined from MVC concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when MVC 300mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when MVC 300mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.
Amprenavir (APV) is the active ingredient/ metabolite of Fosamprenavir (FPV). MVC minimum concentration (Cmin), maximum concentration (Cmax), and area under the plasma concentration-time curve (AUC), as determined from MVC concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when MVC 300mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when MVC 300mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.
Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
AUC (0-12) is the area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose.
AUC (0-24) is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose.
MRAUC12 is the ratio of AUC12 of maraviroc to AUC12 of maraviroc's metabolites. Metabolites of Maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573. AUC12 is the area under the plasma concentration-time profile from time 0 to 12 hours post-dose.
To assess the safety and tolerability of single and repeat inhaled doses of GSK2339345 administered by an aqueous droplet inhaler
To assess the changes in oropharyngeal sensation caused by single and repeat inhaled doses of GSK2339345 administered by an aqueous droplet inhaler
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Group A | ACTIVE_COMPARATOR | Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID |
| Group B | ACTIVE_COMPARATOR | Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID |
| Group C | ACTIVE_COMPARATOR | Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID |
| Group D | ACTIVE_COMPARATOR | Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID |
| Group E | ACTIVE_COMPARATOR | Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID |
| Group F | ACTIVE_COMPARATOR | Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD |
| Arm A | EXPERIMENTAL | maraviroc (Selzentry, Celsentri) 150 mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir (Reyataz) in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir (Prezista)/ritonavir (Norvir)((800/100 mg) QD or lopinavir/ritonavir (Kaletra, Aluvia)(400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir (Prezista)/ritonavir (Norvir) or lopinavir/ritonavir (Kaletra, Aluvia)(, then the subject must be discontinued from the study. |
| Arm B | EXPERIMENTAL | emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir/ritonavir (800/100 mg) QD or lopinavir/ritonavir (400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir/ritonavir or lopinavir/ritonavir, then the subject must be discontinued from the study. |
| 2 | PLACEBO_COMPARATOR | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | PLACEBO_COMPARATOR | - |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| D | EXPERIMENTAL | - |
| E | PLACEBO_COMPARATOR | - |
| Cohort 1 | EXPERIMENTAL | African-Americans with No CYP3A5\*1 alleles (poor metabolizer) |
| Cohort 2 | EXPERIMENTAL | African-Americans with One CYP3A5\*1 allele (intermediate metabolizer) |
| Cohort 3 | EXPERIMENTAL | African-Americans with Two CYP3A5\*1 alleles (extensive metabolizer) |
| Cohort 4 | EXPERIMENTAL | Caucasians with No CYP3A5\*1 alleles (poor metabolizer) |
| Maraviroc | ACTIVE_COMPARATOR | - |
| Maraviroc + Boceprevir | EXPERIMENTAL | - |
| Maraviroc + Telaprevir | EXPERIMENTAL | - |
| Sequence 1 | EXPERIMENTAL | Treatment A: 1 tablet of GSK2838510 (maraviroc 300 mg, lamivudine 150 mg, and zidovudine 300 mg as a combined formulation) after an overnight fast Washout Treatment B: 1 tablet of maraviroc 300 mg + 1 tablet of Combivir taken concurrently after an overnight fast. |
| Sequence 2 | EXPERIMENTAL | Treatment B: 1 tablet of maraviroc 300 mg + 1 tablet of Combivir taken concurrently after an overnight fast. Washout Treatment A: 1 tablet of GSK2838510 (maraviroc 300 mg, lamivudine 150 mg, and zidovudine 300 mg as a combined formulation) after an overnight fast |
| Digoxin | ACTIVE_COMPARATOR | - |
| Digoxin + Maraviroc | EXPERIMENTAL | - |
| Active group | OTHER | maraviroc dosing group |
| Name | Type | Description |
|---|---|---|
| Maraviroc | DRUG | Maraviroc should be dosed BID with total dose adjusted according to the other drugs the patient is taking. Maraviroc may be taken with or without food. The subject should only take missed doses if it is not within 6 hours prior to the planned next dose. No dose adjustment of OBT is required due to the presence of maraviroc. |
| Fosamprenavir | DRUG | 1400 mg BID, 700 mg BID or 1400 mg QD |
| Ritonavir | DRUG | 100 mg BID, 100 mg QD |
| Maraviroc (UK-427,857) | DRUG | maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. |
| optimized background therapy | DRUG | \[OBT (3-6 drugs based on treatment history and resistance testing)\] |
| Placebo | DRUG | Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy \[OBT (3-6 drugs based on treatment history and resistance testing)\] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. |
| Maraviroc (Part 1) | DRUG | 300 mg twice daily x 5 days |
| Maraviroc (Part 2) | DRUG | 150 mg once daily x 10 days |
| Darunavir/cobicistat (Part 2) | DRUG | 800/150 mg once daily x 10 days |
| Maraviroc + Boceprevir | DRUG | Maraviroc 150 mg BID + Boceprevir 800 mg TID x 10 days with food |
| Maraviroc + Telaprevir | DRUG | Maraviroc 150 mg BID + Telaprevir 800 mg TID x 10 days with food |
| Combivir | DRUG | 1 tablet: lamivudine 150mg, zidovudine 300mg |
| GSK2838510 | DRUG | Maraviroc 300mg, lamivudine 150mg, zidovudine 300mg |
| Fosamprenavir/ritonavir | DRUG | fosamprenavir/ritonavir 700/100 mg BID x 10 days |
| Maraviroc + Fosamprenavir/ritonavir | DRUG | maraviroc 300 mg BID + fosamprenavir/ritonavir 700/100 mg BID x 10 days |
| Digoxin | DRUG | Oral Digoxin 0.25 mg single dose |
| maraviroc (Selzentry, Celsentri) | DRUG | 12 subjects will receive a single dose of 300 mg maraviroc (two 150 mg maraviroc commercial tablets) under fasting conditions. |
Inclusion Criteria: * Subjects with limited or no approved treatment options available to them due to resistance or intolerance; * Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA ≥ 1000 copies/ml, at screening. * Have only R5 HIV-1 at S...
Maraviroc is an investigational small molecule being studied for the treatment of Human Immunodeficiency Virus-1 (HIV-1) infections. It is being developed by GSK plc (ticker: GSK) and has completed clinical trials in patients with HIV infections, including those in Phase 2 and Phase 3 studies.
Maraviroc is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in clinical development for the treatment of HIV-1 infections, with completed trials in multiple countries.
Maraviroc is in Phase 3 clinical development for the treatment of HIV-1 infections. It has completed four clinical trials, including a Phase 3 expanded access program, and is not yet approved by regulatory authorities. The drug remains investigational and is still in clinical development.
Maraviroc has completed four clinical trials, including NCT00098306 and NCT00098722, which were Phase 2 studies of Maraviroc in combination with optimized background therapy for HIV-1 infected subjects. NCT00426660 was a Phase 3 expanded access program, and NCT00643643 was a Phase 2 pharmacokinetics study.
Maraviroc is a small molecule that targets the CCR5 receptor, which is involved in HIV-1 entry into cells. By blocking this receptor, the drug aims to prevent the virus from infecting healthy cells. This mechanism is being studied in clinical trials for the treatment of HIV-1 infections.
Yes, Maraviroc is also known as UK-427,857. Clinical trials, such as NCT00098306 and NCT00098722, refer to the drug as Maraviroc (UK-427,857), confirming that these names refer to the same investigational compound being developed for HIV-1 infections.