Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Raltegravir Film-coated · 1 trial · 1 indication
A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
| Arm | Type | Description |
|---|---|---|
| Raltegravir Film-coated Tablet | EXPERIMENTAL | Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks |
| Raltegravir Chewable Tablet | EXPERIMENTAL | Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks |
| Name | Type | Description |
|---|---|---|
| Raltegravir Film-coated Tablet | DRUG | - |
| Raltegravir Chewable Tablet | DRUG | - |
| Other Anti-Retroviral Therapy | DRUG | At baseline, the investigator selected the other anti-retroviral therapies to be used in combination with raltegravir based on current treatment guidelines, the participant's treatment history, and prior anti-retroviral resistance testing |
Inclusion Criteria: * HIV positive * Weight of at least 7 kg * HIV RNA ≥1000 copies/mL within 45 days before study treatment * Participants of reproductive potential and sexually active agree to remain abstinent or use (or have their partner use) an acceptable method of birth control throughout th...
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Raltegravir Film-coated is used for the treatment of HIV Infection. It is an investigational small molecule being studied in combination with other antiretroviral therapies. The drug is currently in Phase 2 clinical development for this indication.
Raltegravir Film-coated is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical research on this small molecule for the treatment of HIV Infection.
Raltegravir Film-coated is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed for this asset.
Raltegravir Film-coated has one completed clinical trial, NCT01717287. This Phase 2 study evaluated the safety, tolerability, and antiretroviral activity of raltegravir in combination with other antiretroviral therapies in Russian children and adolescents infected with HIV-1.
Raltegravir Film-coated is a formulation of raltegravir, which is also known by the code MK-0518. The clinical trial NCT01717287 refers to the drug as MK-0518, confirming that these names refer to the same investigational compound.