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NCT00038480 Clinical Trial

Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants

HIV Infections Clinical Trial

Official title:
A Phase I/II Study of Lopinavir/Ritonavir in HIV-1 Infected Infants Less Than 6 Months of Age

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00038480
Other study ID # P1030
Secondary ID 10041PACTG P1030
Status Completed
Phase Phase 1
First received
Last updated
Est. completion date September 2007

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to find out if the drug lopinavir/ritonavir (LPV/RTV) is safe and well tolerated in HIV infected infants. This study will also determine the most effective dose of LPV/RTV for infants.

Description:

LPV/RTV has shown significant antiviral activity and tolerability in clinical trials in adults and children over 6 months of age. LPV/RTV has been approved by the FDA to treat older children and adults with HIV. Data for children under 6 months, however, have not been available. LPV/RTV has not been approved for infants less than 6 months old, and the appropriate dose for young infants is not known. Dosing guidelines are needed for young infants, most of whom are in the early stages of primary infection. This study will help identify an appropriate dose range of LPV/RTV and evaluate response to therapy in infants less than 6 months of age. The study will also evaluate whether early therapy allows normal development of the immune system. Infants between 14 days and 6 months of age will receive LPV/RTV in combination with 2 nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their physicians. Twelve-hour pharmacokinetic sampling is performed on Day 14 of drug treatment and when the patient reaches 12 months of age. Patients will undergo a physical exam, medical history assessment, and blood collection at selected study visits. Study visits will occur every 2 weeks for the first 8 weeks, then every 4 weeks until the end of the first year of the study. Study visits during the second year will be every 12 weeks until the end of the study. The parent or guardian will be contacted by phone every 6 weeks to monitor adverse drug effects. Participants between the ages of 6 weeks but less than 6 months old will be followed for 96 weeks after the enrollment of the last participant. Participants between the ages of 14 weeks but less than 6 weeks will be followed for 48 weeks after the enrollment of the last participant.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Months
Eligibility Inclusion Criteria - HIV infected - Viral load greater than 10,000 copies/ml within 30 days prior to study entry - Weigh more than 5.5 lbs at the time of enrollment - Agree to take 2 nucleoside reverse transcriptase inhibitors (NRTIs) in addition to LPV/RTV - Have consent of parent or guardian willing to provide signed informed consent and to have the infant followed at a PACTG site Exclusion Criteria - Currently taking a nonnucleoside reverse transcriptase inhibitor or protease inhibitor (PI) while on study - Previously used LPV/RTV. Patients who were treated previously with other PIs are not excluded. Prior or concurrent maternal treatment with LPV/RTV is not excluded. - For patients less than 6 weeks old at time of enrollment, less than 34 weeks gestation at delivery OR for patients 6 or more weeks old at time of enrollment, less than 32 weeks gestation at delivery - Any laboratory toxicity of Grade 3 or greater. Hyperlipasemia of Grade 2 or higher is also excluded. - Newly diagnosed acute opportunistic or serious bacterial infection requiring therapy at the time of enrollment - Chemotherapy for active cancer - Certain medications - Any other clinically significant conditions, other than HIV infection, that would interfere with the study

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lopinavir/Ritonavir

Locations
Country Name City State
Brazil SOM Federal University Minas Gerais Brazil NICHD CRS Minas Gerais
Brazil Univ. of Sao Paulo Brazil NICHD CRS Sao Paulo
Puerto Rico San Juan City Hosp. PR NICHD CRS San Juan
United States Univ. of Colorado Denver NICHD CRS Aurora Colorado
United States Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases Baltimore Maryland
United States Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology Baltimore Maryland
United States Children's Hosp. of Boston NICHD CRS Boston Massachusetts
United States Bronx-Lebanon Hosp. IMPAACT CRS Bronx New York
United States Chicago Children's CRS Chicago Illinois
United States Univ. of Florida Jacksonville NICHD CRS Jacksonville Florida
United States St. Jude/UTHSC CRS Memphis Tennessee
United States Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. Oakland California
United States St. Christopher's Hosp. for Children Philadelphia Pennsylvania
United States UCSF Pediatric AIDS CRS San Francisco California
United States Baystate Health, Baystate Med. Ctr. Springfield Massachusetts
United States USF - Tampa NICHD CRS Tampa Florida
United States Children's National Med. Ctr. Washington DC NICHD CRS Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Brazil,  Puerto Rico, 

References & Publications (6)

Chadwick EG, Pinto J, Yogev R, Alvero CG, Hughes MD, Palumbo P, Robbins B, Hazra R, Serchuck L, Heckman BE, Purdue L, Browning R, Luzuriaga K, Rodman J, Capparelli E; International Maternal Pediatric Adolescent Clinical Trials Group (IMPAACT) P1030 Team. — View Citation

Chadwick EG, Yogev R, Alvero CG, Hughes MD, Hazra R, Pinto JA, Robbins BL, Heckman BE, Palumbo PE, Capparelli EV; International Pediatric Adolescent Clinical Trials Group (IMPAACT) P1030 Team. Long-term outcomes for HIV-infected infants less than 6 months — View Citation

Equils O, Garratty E, Wei LS, Plaeger S, Tapia M, Deville J, Krogstad P, Sim MS, Nielsen K, Bryson YJ. Recovery of replication-competent virus from CD4 T cell reservoirs and change in coreceptor use in human immunodeficiency virus type 1-infected children responding to highly active antiretroviral therapy. J Infect Dis. 2000 Sep;182(3):751-7. Epub 2000 Aug 15. — View Citation

Luzuriaga K, McManus M, Catalina M, Mayack S, Sharkey M, Stevenson M, Sullivan JL. Early therapy of vertical human immunodeficiency virus type 1 (HIV-1) infection: control of viral replication and absence of persistent HIV-1-specific immune responses. J Virol. 2000 Aug;74(15):6984-91. — View Citation

Luzuriaga K, Wu H, McManus M, Britto P, Borkowsky W, Burchett S, Smith B, Mofenson L, Sullivan JL. Dynamics of human immunodeficiency virus type 1 replication in vertically infected infants. J Virol. 1999 Jan;73(1):362-7. — View Citation

Sáez-Llorens X, Violari A, Deetz CO, Rode RA, Gomez P, Handelsman E, Pelton S, Ramilo O, Cahn P, Chadwick E, Allen U, Arpadi S, Castrejón MM, Heuser RS, Kempf DJ, Bertz RJ, Hsu AF, Bernstein B, Renz CL, Sun E. Forty-eight-week evaluation of lopinavir/ritonavir, a new protease inhibitor, in human immunodeficiency virus-infected children. Pediatr Infect Dis J. 2003 Mar;22(3):216-24. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Trough concentration of LPV and pharmacokinetic parameters Weeks 8, 16, 24, 36, 48, 60, 72, 84, and 96
Primary Recurrent treatment-related Grade 3 and non-life threatening Grade 4 toxicity or single occurence of life-threatening Grade 4 toxicity Throughout study
Secondary Change in CD4 and CD8 count and percentage from baseline. HIV-1 specific CD4 count and CD8 mediated and humoral responses Study entry and Weeks 12, 24, 36, 48, 60, 72, 84, and 96
Secondary Time to virologic failure Throughout study
Secondary Suppression of viral load to less than 400 copies/ml and less than 50 copies/ml Study entry and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 36, 40, 48, 60, 72, 84, and 96
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