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A Study of Lopinavir/Ritonavir in Infants with HIV Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Study of Lopinavir/Ritonavir in Infants with HIV conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Study of Lopinavir/Ritonavir in Infants with HIV Clinical research trials and A Study of Lopinavir/Ritonavir in Infants with HIV healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Study of Lopinavir/Ritonavir in Infants with HIV. A Study of Lopinavir/Ritonavir in Infants with HIV Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Study of Lopinavir/Ritonavir in Infants with HIV clinical trial. Test subjects typically receive the most effective healthcare possible for their A Study of Lopinavir/Ritonavir in Infants with HIV condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of Lopinavir/Ritonavir in Infants with HIV  A Study of Lopinavir/Ritonavir in Infants with HIV
A Study of Lopinavir/Ritonavir in Infants with HIV
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: The purpose of this study is to find out if the drug lopinavir/ritonavir (LPV/RTV) is safe and well tolerated in infants infected with HIV. The study wants to find the best LPV/RTV dose range for infants and to find out how the drug treatment affects the amount of HIV and the number of certain T cells (cells that fight HIV) in the blood of HIV-infected infants. LPV/RTV has been approved by the U.S. Food and Drug Administration to treat older children and adults with HIV. It has not been approved for infants less than 6 months old, and the appropriate dosage for young infants is not known. This study will help doctors decide if LPV/RTV is a good treatment for infants with HIV and will help establish dosing guidelines for children under 6 months old.
Details: LPV/RTV has shown significant antiviral activity and tolerability in clinical trials in adults and children over 6 months of age. Data for children under 6 months, however, have not been available. 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 receive LPV/RTV in combination with 2 nucleoside reverse transcriptase inhibitors (NRTIs). Patients are followed for 24 months after enrollment of the last patient. Twelve-hour pharmacokinetic sampling is performed on Day 14 of drug treatment and when the patient reaches 12 months of age. HIV RNA levels, drug resistance, and immunologic profiles are monitored regularly. Patients visit the clinic every other week for the first 8 weeks, then every 4 weeks until the end of the first year of the study. Patients visit the clinic every 12 weeks for the remainder of the study, and the parent or guardian is contacted by phone every 6 weeks to monitor adverse effects.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Safety/Efficacy Study
Minimum Age/Maximum Age: /6 Months
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are between the ages of 14 days and 6 months old. - Are infected with HIV. - Have a viral load of over 10,000 copies/ml within 30 days of study entry. - Have a parent or legal guardian able and willing to provide signed informed consent and to have the infant followed at a PACTG site. - Weigh more than 5.5 pounds at the time of enrollment. - Agree to take 2 nucleoside reverse transcriptase inhibitors (NRTIs) in addition to LPV/RTV. Exclusion Criteria Patients may not be eligible for this study if they: - Have a newly diagnosed acute opportunistic or serious bacterial infection requiring therapy at the time of enrollment. - Have any other clinically significant conditions, other than HIV infection, that would interfere with the study. - Were less than 34 weeks gestation at delivery (patients less than 6 weeks old at time of enrollment) or less than 32 weeks gestation at delivery (patients 6 or more weeks old at time of enrollment). - Plan on using a non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) while on study. - Have used Kaletra (LPV/RTV) in the past.
Total Enrollment: 12
Location and Contact Information:
Overall Study Official:
EllenChadwick, Study Chair, Chicago Children's Memorial Hosp
UCSF Moffitt Hosp (Pediatric) *Recruiting*
San Francisco, California, 94143-0105
United States
Recruiting Debbie Trevithick 415-476-6480
Univ of Miami (Pediatric) *Recruiting*
Miami, Florida, 33136
United States
Recruiting Patricia Bryan 305-243-4447
UCSD Mother, Child, & Adolescent HIV Program *Recruiting*
San Diego, California, 92103
United States
Recruiting Linda Proctor 619-543-8080
University of North Carolina at Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7220
United States
Recruiting Elizabeth Pitkin 919-966-9110
Univ of Florida Health Science Ctr / Pediatrics *Recruiting*
Jacksonville, Florida, 32209
United States
Recruiting Michelle Eagle 904-244-5331
Saint Jude Children's Research Hosp of Memphis *Recruiting*
Memphis, Tennessee, 381052794
United States
Recruiting Jill Utech 901-495-3490
Baystate Med Ctr of Springfield *Recruiting*
Springfield, Massachusetts, 01199
United States
Recruiting MariPat Toye 413-794-5399
State Univ of New York at Stony Brook *Recruiting*
Stony Brook, New York, 11776
United States
Recruiting Michell Davi 631-444-1313
Univ of Massachusetts Med School *Recruiting*
Worcester, Massachusetts, 016550001
United States
Recruiting Donna Christian 508-856-1692
Univ of Med & Dentistry of NJ/Univ Hospital *Recruiting*
Newark, New Jersey, 07103
United States
Recruiting Mary Hoyt 973-972-3118
Duke University (Pediatric) *Recruiting*
Durham, North Carolina, 27705
United States
Recruiting John Swetnam 919-416-3447
Univ of Maryland (Pediatric) *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Mary MacFadden 410-706-8933
Univ of South Florida *Recruiting*
St. Petersburg, Florida, 33701
United States
Recruiting Carolyn Graisbery 727-892-4184
The Univ of Chicago Childrens Hospital *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Pamela Lofton 773-702-3853
Tulane Univ., Charity Hosp of New Orleans *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Margaret Cowie 504-586-3804
Johns Hopkins Univ (Pediatric) *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Suzanne Marvin 410-955-9749
Childrens Hosp, Oakland (Pediatric) *Recruiting*
Oakland, California, 94609-1809
United States
Recruiting Teresa Courville 510-428-3885
Chicago Children's Memorial Hosp *Recruiting*
Chicago, Illinois, 606143394
United States
Recruiting Debbie Fonken-Cloutier 773-880-3669
Children's National Med Ctr *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Veronica Amos 202-884-2837
Howard Univ Hosp *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Patricia Yu 202-865-4578
SUNY Upstate Med Univ *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Maureen Famiglietti 312-464-6331
New York University School of Medicine *Recruiting*
New York City, New York, 10016
United States
Recruiting Nagamah Deygoo 212-263-5680
Children's Hosp of Boston *Recruiting*
Boston, Massachusetts, 021155724
United States
Recruiting Kirk Bertelsen 617-355-8198
Harlem Hosp *Recruiting*
New York City, New York, 10037
United States
Recruiting Delia Calo 212-939-4045
Bronx Lebanon Hosp Ctr *Recruiting*
Bronx, New York, 10457
United States
Recruiting Caroline Nubel 718-960-1020
San Juan City Hosp *Recruiting*
San Juan, ,
Puerto Rico
Recruiting Maria Pilar Thurin 787-765-4186
Columbia Presbyterian Med Ctr *Recruiting*
New York City, New York, 10032
United States
Recruiting Marie Donahue 212-305-7222
Additional Information:
Study ID Numbers: PACTG P1030;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038480
Other Hiv Infections Studies:
1. Evaluation of the Changes in HIV-1 Burden in Peripheral Blood and Lymphoid Tissue Following Zidovudine ( AZT ) Treatment in HIV-1-Infected Patients With CD4+ Cells Between 100 and 500 Cells/mm3.
2. A Study to Demonstrate that Anti-HIV Drug Therapy can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination from the Body
3. Treatment Program for Anemia in AIDS Patients
4. A Pilot Study of the Efficacy of Recombinant Alpha Interferon (IFN-A2b) and zidovudine (AZT) in the Treatment of Progressive Multifocal Leukoencephalopathy (PML) Complicating HIV-1 Infection
5. Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Stony Brook Clinical Trials
A Study of Lopinavir/Ritonavir in Infants with HIV
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