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Also known as Raltegravir Film-coated Tablet
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...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
Raltegravir Film-coated is used to treat HIV Infection. It is a small molecule antiretroviral therapy studied in combination with other antiretroviral therapies in children and adolescents infected with human immunodeficiency virus type 1 (HIV-1). The film-coated tablet formulation is the subject of a Phase 2 study conducted in Russian children and adolescents aged 2 years and older.
Raltegravir Film-coated is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck is the sponsor of the clinical program evaluating this film-coated tablet formulation in pediatric and adolescent patients with HIV-1 infection.
Raltegravir Film-coated is in Phase 2 clinical development. The program includes one completed Phase 2 trial, and no active trials are currently listed. The completed study enrolled 32 participants and evaluated the safety, tolerability, and antiretroviral activity of the film-coated tablet in combination with other antiretroviral therapies.
Raltegravir Film-coated has been evaluated in one clinical trial, NCT01717287, titled A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1). The Phase 2 trial is completed and enrolled 32 participants aged 2 years and older.
Yes, Raltegravir Film-coated and Raltegravir Film-coated Tablet refer to the same product. Raltegravir Film-coated Tablet is an alternative name for this formulation. Both names describe the film-coated tablet version of raltegravir being studied by Merck & Company, Inc. in HIV Infection.