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GSK1349572 (dolutegravir)
Dolutegravir inhibits HIV integrase, preventing the virus from inserting its genetic material into human DNA.
Dolutegravir inhibits HIV integrase, preventing the virus from inserting its genetic material into human DNA. Used for HIV-1 infection in treatment-naïve adults, HIV-1 infection in treatment-experienced adults.
At a glance
| Generic name | GSK1349572 (dolutegravir) |
|---|---|
| Sponsor | ViiV Healthcare |
| Drug class | Integrase strand transfer inhibitor (INSTI) |
| Target | HIV integrase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Dolutegravir is an integrase strand transfer inhibitor (INSTI) that binds to the active site of HIV integrase and blocks the enzyme's ability to catalyze the integration of viral DNA into the host cell genome. By preventing this critical step in the HIV replication cycle, the drug stops viral propagation and reduces viral load in infected individuals.
Approved indications
- HIV-1 infection in treatment-naïve adults
- HIV-1 infection in treatment-experienced adults
Common side effects
- Insomnia
- Headache
- Diarrhea
- Nausea
- Fatigue
Key clinical trials
- Early Metabolic Effects of Dolutegravir or Tenofovir Alefenamide in Healthy Volunteers (PHASE2)
- Shortened Regimen for Drug-susceptible TB in Children (PHASE3)
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants (PHASE3)
- A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa (NA)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) (PHASE2)
- A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy (PHASE3)
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:
- GSK1349572 (dolutegravir) CI brief — competitive landscape report
- GSK1349572 (dolutegravir) updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI