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Placebo for dolutegravir (DTG)
A placebo contains no active pharmaceutical ingredient and produces no direct pharmacological effect.
A placebo contains no active pharmaceutical ingredient and produces no direct pharmacological effect. Used for Control arm in clinical trials of dolutegravir for HIV-1 infection.
At a glance
| Generic name | Placebo for dolutegravir (DTG) |
|---|---|
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Placebos are inert substances used as controls in clinical trials to establish the efficacy of an active drug by comparison. Any observed effects in placebo groups are attributed to the placebo effect (psychological and contextual factors) rather than direct drug action. In this case, it serves as a control comparator for dolutegravir (DTG), an integrase inhibitor used in HIV treatment.
Approved indications
- Control arm in clinical trials of dolutegravir for HIV-1 infection
Common side effects
Key clinical trials
- Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy (PHASE2)
- Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults (PHASE3)
- Tenofovir-lamivudine-dolutegravir Combination as Second-line ART: a Randomised Controlled Trial (PHASE2)
- The Effect of Aspirin on HIV Disease Progression Among HIV- Infected Individuals Initiating Anti- Retroviral Therapy (PHASE2)
- Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND) (PHASE4)
- Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults (PHASE3)
- Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults (PHASE3)
- Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed (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 |
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