| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00426660 | Expanded Access Program for Maraviroc At Multiple Centers | PHASE3 | COMPLETED | 1,047 | — | — | Feb 1, 2007 | Jun 1, 2010 | Jun 29, 2016 | 361 | United States, Argentina +24 |
| NCT00098722 | Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects | PHASE2 | COMPLETED | 474 | — | — | Dec 1, 2004 | Apr 1, 2011 | May 16, 2012 | 172 | United States, Australia +11 |
| NCT00098306 | Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects | PHASE2 | COMPLETED | 601 | — | — | Nov 1, 2004 | Apr 1, 2011 | Apr 27, 2012 | 22 | United States, Canada |
| NCT00643643 | Pharmacokinetics, Pharmacodynamics, And Safety Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus | PHASE2 | COMPLETED | 41 | — | — | Oct 1, 2002 | Jun 1, 2003 | Nov 10, 2010 | 6 | Germany, Netherlands +1 |
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.
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.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| 3 | EXPERIMENTAL | - |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| D | EXPERIMENTAL | - |
| E | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| maraviroc | DRUG | The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID. |
| 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. |
Inclusion Criteria: * Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening * Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay * Minimum age must be 16...