Kaletra

Phase 3Small molecule

GSK

Kaletra is one of 49 small molecule programs targeting Buprenorphine. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

BuprenorphineCompleted

TreatmentActive, not recruiting

BuprenorphinePreclinical

Completed

TreatmentPhase 3

Active, not recruiting

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Kaletra

GSK

Phase 3

2 2

Alfenta

Jazz Pharmaceuticals

Preclinical

1 3

Niclocide

Bayer

Preclinical

1 4

Theo-Dur

Pfizer

Preclinical

1 5

Levulan

Sun Pharmaceutical Industries, Inc.

Preclinical

1 6

Lamprene

Novartis

Preclinical

1 7

Emtriva

Gilead

Preclinical

1 8

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 9

Foscavir

CClinigen, Inc.

Preclinical

6 10

Sirturo

WWim Janssens

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2029

Phase 2/3Active, not recruiting

Treatment

NCT02369406

Clinical

Trials by Indication[1]

HIV3 trials

Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects

Completed·KKirby Institute·Phase 4·NCT00192621·50 enrolled

GW873140 In Combination With Kaletra In HIV Infected Subjects

Terminated· GSK logo

GSK·Phase 2·NCT00102778·175 enrolled

High Dose Ritonavir/Lopinavir Liquid Formulation in Salvage Therapy for Protease Inhibitor Resistant HIV Disease

Unknown status·LLampiris, Harry W., M.D.·N/A·NCT00247143·20 enrolled

Treatment2 trials

Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens

Completed· Pfizer logo

Pfizer·Phase 2·NCT00052117·300 enrolled

Early Infant HIV Treatment in Botswana

Active, not recruiting·HHarvard School of Public Health (HSPH)·Phase 2/3·NCT02369406·67 enrolled

HIV infection1 trial

Analysis of Changes in Adipose Tissue of Patients With Lipoatrophy HIV Infection Treated With Nucleoside Thymidine, After Switching to Monotherapy With Lopinavir / Ritonavir

Terminated·IInes Perez·Phase 4·NCT01031849·7 enrolled

Interaction1 trial

Study of Pharmacokinetic Interaction Between Kaletra® (LPV/r) and BILR 355 BS Plus Ritonavir in Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02256826·34 enrolled

Buprenorphine1 trial

Pharmacokinetic Interactions Between Buprenorphine and Kaletra (Lopinavir/Ritonavir)

Completed·YYale University·N/A·NCT00571961·12 enrolled

9 more indications

Adult1 trial

Study of the 48-Week Virologic and Immunologic Response to Lopinavir/Ritonavir (Kaletra) in HIV Positive Adult Patients

Completed·TTherapeutic Concepts·Phase 2·NCT00116636·40 enrolled

Pediatric1 trial

Pediatric Study for Appropriate Dose of Ritonavir Boosted Lopinavir in Thai HIV-infected Children (PEARL)

Completed·TThe HIV Netherlands Australia Thailand Research Collaboration·Phase 3·NCT01307124·199 enrolled

Pregnancy1 trial

The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT00766818·12 enrolled

HIV-11 trial

A Study Exploring an Induction-Maintenance Kaletra-Based Therapy Versus a Sustiva-Based Regimen in Previously Non-Treated, HIV-1/HCV Co-Infected Subjects

Withdrawn·AAbbott·Phase 2·NCT00121017·200 enrolled

Prevention1 trial

Prevention of HIV1 Mother to Child Transmission Without Nucleoside Analogue Reverse Transcriptase Inhibitors in the Pre-partum Phase. ANRS 135 Primeva

Completed·AANRS, Emerging Infectious Diseases·Phase 2/3·NCT00424814·105 enrolled

CAR1 trial

A Simplified Kaletra® (Lopinavir/Ritonavir)-Based Therapy Versus a Sustiva® (Efavirenz)-Based Standard of Care in Previously Non-Treated HIV-Infected Subjects

Completed·AAbbott·Phase 2·NCT00075231·150 enrolled

Monotherapy1 trial

Kaletra Monotherapy in HIV/HCV Co-infected Subjects

Completed·OOttawa Hospital Research Institute·Phase 3·NCT00508222·22 enrolled

Adverse Effect1 trial

Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection

Completed·UUniversity of Cincinnati·Phase 4·NCT00885664·60 enrolled

Unspecified2 trials

KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks

Completed· GSK logo

GSK·Phase 3·NCT00085943·866 enrolled

PK of Efavirenz & Lopinavir Nano-formulations in Healthy Volunteers

Suspended·SSt Stephens Aids Trust·Phase 1·NCT02631473·50 enrolled

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Kaletra. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Kaletra compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Kaletra. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — GSK company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: GSK

Kaletra

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2029

Trials by Indication[1]

HIV3 trials

Treatment2 trials

HIV infection1 trial

Interaction1 trial

Buprenorphine1 trial

Adult1 trial

Pediatric1 trial

Pregnancy1 trial

HIV-11 trial

Prevention1 trial

CAR1 trial

Monotherapy1 trial

Adverse Effect1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

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