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Highly active antiretroviral therapy
HAART uses a combination of antiretroviral drugs from different classes to suppress HIV replication by targeting multiple steps of the viral lifecycle simultaneously.
HAART uses a combination of antiretroviral drugs from different classes to suppress HIV replication by targeting multiple steps of the viral lifecycle simultaneously. Used for HIV-1 infection (treatment and suppression), Prevention of mother-to-child HIV transmission, Post-exposure prophylaxis (PEP) in certain regimens.
At a glance
| Generic name | Highly active antiretroviral therapy |
|---|---|
| Sponsor | PETHEMA Foundation |
| Drug class | Antiretroviral combination therapy |
| Target | HIV reverse transcriptase, HIV protease, HIV integrase (depending on regimen composition) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
HAART typically combines nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and/or protease inhibitors (PIs) to block HIV reverse transcription and protease activity. This multi-drug approach prevents the virus from replicating and reduces viral load to undetectable levels, allowing immune system recovery and preventing disease progression to AIDS.
Approved indications
- HIV-1 infection (treatment and suppression)
- Prevention of mother-to-child HIV transmission
- Post-exposure prophylaxis (PEP) in certain regimens
Common side effects
- Nausea and gastrointestinal disturbances
- Lipodystrophy (fat redistribution)
- Peripheral neuropathy
- Hepatotoxicity
- Hyperlipidemia
- Hyperglycemia
- Rash
- Lactic acidosis (rare but serious)
Key clinical trials
- REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE: A Multi-Center, Single-Arm, Open-Label, Phase 4 Study Assessing the Safety and Efficacy of B/F/TAF in HIV-Positive Adults Returning to Care After Experiencing a Treatment Interruption of ≥12 Weeks (PHASE4)
- A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) (PHASE2)
- Differentiated Service Delivery for Pregnant and Postpartum Women Living With HIV and Their Infants (NA)
- Baricitinib Curative Repression of HIV-1 (PHASE2)
- More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents (PHASE1, PHASE2)
- Efficacy and Safety of Doravirine in the Rapid Initiation (PHASE4)
- Strategies to Improve the HIV Care Continuum Among Key Populations in India (NA)
- Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART) (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:
- Highly active antiretroviral therapy CI brief — competitive landscape report
- Highly active antiretroviral therapy updates RSS · CI watch RSS
- PETHEMA Foundation portfolio CI