FDA approved Kaletra (lopinavir/ritonavir) for HIV-1 Infection in Adults and ChildrenFDA approved new HIV drug Kaletra for adults and children.

FDA From the archive Source published September 15, 2000 Summary added July 29, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider genotypic or phenotypic testing to guide Kaletra use due to resistance-associated substitutions affecting virologic response.

The FDA has approved Kaletra (lopinavir/ritonavir), a protease inhibitor, for the treatment of HIV-1 infection in adults and pediatric patients aged 14 days and older. Kaletra is indicated for use in combination with other antiretroviral agents. The approval provides a new option for HIV-1 management, particularly in patients with limited resistance-associated substitutions. Clinicians should note that genotypic or phenotypic testing and treatment history should guide use, as baseline lopinavir resistance-associated substitutions affect virologic response. Kaletra is available as tablets and oral solution, with dosing adjustments required for certain concomitant medications and in pregnant women.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Not reported in label.

Indication & Patient Population

Kaletra is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of Kaletra. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to Kaletra.

Dosing & Administration

Tablets may be taken with or without food, swallowed whole and not chewed, broken, or crushed. Oral solution must be taken with food. Oral solution is not recommended for use with polyurethane feeding tubes; silicone or PVC tubes can be used. Adults: Total recommended daily dosage is 800/200 mg given once or twice daily. Once daily dosing is not recommended in patients with three or more lopinavir resistance-associated substitutions, in combination with carbamazepine, phenobarbital, phenytoin, efavirenz, nevirapine, or nelfinavir, or in pregnant women. Pediatric patients (14 days and older): Twice daily dosing based on body weight or body surface area; once daily not recommended. Oral solution should not be administered to neonates before postmenstrual age of 42 weeks and postnatal age of at least 14 days. Pregnancy: 400/100 mg twice daily in patients with no documented lopinavir-associated resistance substitutions.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Kaletra is an HIV-1 protease inhibitor used in combination with other antiretroviral agents for treatment of HIV-1 infection. Genotypic or phenotypic testing should guide use due to impact of baseline resistance-associated substitutions on virologic response.

The FDA has approved a new HIV medicine called Kaletra. It is a type of drug known as a protease inhibitor. Kaletra is used to treat HIV-1 infection in adults and children as young as 14 days old. It must be taken together with other antiretroviral medicines. This approval provides another choice for managing HIV, especially for patients whose virus has limited resistance to this class of drugs.

Kaletra comes as tablets and an oral solution. Dosing may need to be adjusted if you take certain other medicines or if you are pregnant. Your doctor will use information from resistance testing and your treatment history to decide if Kaletra is right for you. The drug works by blocking a key step in the virus's life cycle, which helps lower the amount of HIV in your body.

This approval means more options are available for HIV treatment. However, it is not a cure. It is important to take Kaletra exactly as prescribed and to keep all follow-up appointments. If you have questions about whether Kaletra is suitable for you, talk to your doctor. They can help you understand the benefits and risks based on your personal health situation.

What this means for you:

Kaletra is a new HIV treatment option, but it must be used with other medicines and under a doctor's care.

Study Details

Study typeFda approval

PublishedSep 2000

View Original Abstract ↓

1 INDICATIONS AND USAGE KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology ( 12.4 )] . KALETRA is an HIV-1 protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients (14 days and older). ( 1 )

FDA approved Kaletra (lopinavir/ritonavir) for HIV-1 Infection in Adults and ChildrenFDA approved new HIV drug Kaletra for adults and children.

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FDA approved Kaletra (lopinavir/ritonavir) for HIV-1 Infection in Adults and ChildrenFDA approved new HIV drug Kaletra for adults and children.

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

Adding Antibiotics to Bone Surgery Didn't Lower Infection Risk

Clinical research that matters. Delivered to your inbox.

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