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ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE (ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE)
ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE (generic name: ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE) is a drug developed by MACLEODS PHARMACEUTICALS LTD. It is currently FDA-approved.
Abacavir, Dolutegravir, and Lamivudine are antiretroviral medications used to treat HIV-1 infection. They work by inhibiting the human immunodeficiency virus type 1 reverse transcriptase enzyme, which is essential for the virus's replication.
At a glance
| Generic name | ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE |
|---|---|
| Sponsor | MACLEODS PHARMACEUTICALS LTD |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Common side effects
- Insomnia
- Headache
- Fatigue
- Dizziness
- Nausea
- Diarrhea
- Depression
- Abnormal dreams
Serious adverse events
- Abacavir hypersensitivity reaction
- Dolutegravir hypersensitivity reaction
- Anaphylaxis
- Liver failure
- Renal failure
- Respiratory failure
- Adult respiratory distress syndrome
- Myolysis
- Erythema multiforme
- Liver injury
Key clinical trials
- A Randomized, 2-Cohort, 2-Period, Single Dose, Crossover Clinical Study to Assess the Effect of Food on the Pediatric Dispersible Tablet Formulations of TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and (Phase 1)
- Contribution of the Integrase Inhibitor Dolutegravir to Obesity and Cardiovascular Disease in Persons Living With HIV (Phase 4)
- A Phase IV Open-label, Multi-centre, Randomised, Dual-arm, Pilot Study to Assess the Feasibility of Switching Individuals Receiving Efavirenz With Continuing Central Nervous System (CNS) Toxicity, to (Phase 4)
- A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Abacavir/Lamivudine (ABC/3TC) Plus a Third Antiretroviral Agent to the Elvitegravi (Phase 3)
- A Phase IIb Study to Select a Once Daily Dose of GSK1349572 Administered With Either Abacavir/Lamivudine or Tenofovir/Emtricitabine in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects (Phase 2)
- A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral T (Phase 3)
- Randomized Clinical Trial to Evaluate the Efficacy of a Dolutegravir Monotherapy (Tivicay®) Versus the Maintenance of a Successful Triple Therapy Using Abacavir + Lamivudine + Dolutegravir (Triumeq®) (Phase 3)
- Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age (Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE CI brief — competitive landscape report
- ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE updates RSS · CI watch RSS
- MACLEODS PHARMACEUTICALS LTD portfolio CI
Frequently asked questions about ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE
What is ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE?
ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE (ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE) is a pharmaceutical drug developed by MACLEODS PHARMACEUTICALS LTD.
Who makes ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE?
ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE is developed and marketed by MACLEODS PHARMACEUTICALS LTD (see full MACLEODS PHARMACEUTICALS LTD pipeline at /company/macleods-pharmaceuticals-ltd).
What is the generic name of ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE?
ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE is the generic (nonproprietary) name of ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE.
What development phase is ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE in?
ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE is FDA-approved (marketed).
What are the side effects of ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE?
Common side effects of ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE include Insomnia, Headache, Fatigue, Dizziness, Nausea, Diarrhea. Serious adverse events: Abacavir hypersensitivity reaction, Dolutegravir hypersensitivity reaction, Anaphylaxis, Liver failure.
Related
- Manufacturer: MACLEODS PHARMACEUTICALS LTD — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing