Dolutegravir: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Dolutegravir appears in the FDA drug-label database. Marketed as Tivicay.
FDA-approved use
TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg [see Microbiology ( 12.4 )]. TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/ mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent. TIVICAY and TIVICAY PD are an HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least 4 weeks and weighing at least 3 kg. ( 1 ) TIVICAY is indicated in combination with rilpivirine as a complete r…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Cardinal Health Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-03-15 |
| Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR. — GlaxoSmithKline LLC | Class III (FDA: unlikely to cause harm) | Terminated | 2024-05-17 |
| Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026. — GlaxoSmithKline LLC | Class III (FDA: unlikely to cause harm) | Terminated | 2022-05-13 |
| Cross Contamination with Other Products: Product contains Promacta (eltrombopag). — Viiv Healthcare Company | Class III (FDA: unlikely to cause harm) | Terminated | 2014-02-11 |
Phase breakdown
Conditions being studied
Recruiting trials involving Dolutegravir
- Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
- Doravirine Dose Optimisation in Pregnancy
- Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study
- Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch
- Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Antiretrovirals
Common questions
Is Dolutegravir FDA-approved?
Yes, marketed as Tivicay.
How many recruiting trials involve Dolutegravir?
5 recruiting trials across 9 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.