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First-line Antiretroviral Therapy
First-line antiretroviral therapy typically combines multiple HIV drugs that inhibit viral reverse transcriptase, protease, or integrase to suppress HIV replication and restore immune function.
First-line antiretroviral therapy typically combines multiple HIV drugs that inhibit viral reverse transcriptase, protease, or integrase to suppress HIV replication and restore immune function. Used for HIV-1 infection, treatment-naïve patients, AIDS prevention and viral load suppression.
At a glance
| Generic name | First-line Antiretroviral Therapy |
|---|---|
| Also known as | Sustiva, Kaletra |
| Sponsor | UPECLIN HC FM Botucatu Unesp |
| Drug class | Antiretroviral combination therapy (NRTI/NNRTI/PI/INSTI) |
| Target | HIV reverse transcriptase, HIV protease, HIV integrase (depending on regimen components) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
First-line antiretroviral regimens usually consist of two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) plus either a non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI), or integrase strand transfer inhibitor (INSTI). These agents work synergistically to block different stages of the HIV replication cycle, preventing viral spread and allowing CD4+ T-cell recovery. The specific combination depends on patient factors, resistance patterns, and tolerability.
Approved indications
- HIV-1 infection, treatment-naïve patients
- AIDS prevention and viral load suppression
Common side effects
- Nausea
- Diarrhea
- Headache
- Rash
- Lipodystrophy
- Hepatotoxicity
- Lactic acidosis
Key clinical trials
- Evaluation of Multiple Interventions to Improve HIV Treatment Outcomes Among People Who Inject Drugs in India (NA)
- A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Failure of a Standard Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)+2N(t)RTI First Line Regimen (PHASE4)
- An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM (PHASE3)
- 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)
- Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection (PHASE1)
- Evaluation of Problem Management Plus in Pregnant Women With HIV in Kenya (NA)
- A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy (PHASE3)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
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:
- First-line Antiretroviral Therapy CI brief — competitive landscape report
- First-line Antiretroviral Therapy updates RSS · CI watch RSS
- UPECLIN HC FM Botucatu Unesp portfolio CI