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Antiretroviral therapy
Antiretroviral therapy (ART) suppresses HIV replication by blocking viral enzymes (reverse transcriptase, integrase, protease) and/or preventing viral entry into CD4+ T cells.
Antiretroviral therapy (ART) suppresses HIV replication by blocking viral enzymes (reverse transcriptase, integrase, protease) and/or preventing viral entry into CD4+ T cells. Used for HIV-1 infection (treatment and prevention), AIDS (acquired immunodeficiency syndrome).
At a glance
| Generic name | Antiretroviral therapy |
|---|---|
| Also known as | cryptococcal antigen negative patients, Anti-Retroviral Therapy, ART |
| Sponsor | ANRS, Emerging Infectious Diseases |
| Drug class | Combination antiretroviral therapy (multiple classes: nucleoside/nucleotide reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase strand transfer inhibitors, entry inhibitors) |
| Target | HIV reverse transcriptase, HIV integrase, HIV protease, HIV envelope glycoproteins (gp120/gp41), CCR5 co-receptor |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
ART typically combines multiple drugs from different classes (NRTIs, NNRTIs, PIs, INSTIs, entry inhibitors) that target distinct steps in the HIV replication cycle. By simultaneously inhibiting multiple viral targets, combination ART reduces the viral load to undetectable levels, preserves immune function, and prevents the emergence of drug-resistant strains. This allows people with HIV to achieve near-normal life expectancy and eliminates sexual transmission risk (undetectable = untransmittable).
Approved indications
- HIV-1 infection (treatment and prevention)
- AIDS (acquired immunodeficiency syndrome)
Common side effects
- Nausea and gastrointestinal disturbance
- Headache
- Fatigue
- Lipodystrophy (fat redistribution)
- Dyslipidemia (elevated cholesterol/triglycerides)
- Hepatotoxicity
- Renal impairment (tenofovir-related)
- Bone density loss (osteoporosis)
- Immune reconstitution inflammatory syndrome (IRIS)
Key clinical trials
- MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003) (PHASE1)
- Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy (PHASE1)
- Liver Fibrosis in HIV-Infected Patients With Elevated Liver Enzymes on Antiretroviral Therapy
- Opioid, HIV and Immune System (PHASE4)
- A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) (PHASE2, PHASE3)
- CABOTEGRAVIR/LENACAPAVIR DUAL LONG ACTING THERAPY (COHORT IMEA 074)
- Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption (PHASE2)
- Evaluation of Multiple Interventions to Improve HIV Treatment Outcomes Among People Who Inject Drugs in India (NA)
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:
- Antiretroviral therapy CI brief — competitive landscape report
- Antiretroviral therapy updates RSS · CI watch RSS
- ANRS, Emerging Infectious Diseases portfolio CI