Anti-HIV Drug Regimens With or Without Protease Inhibitors and Drug Level Monitoring in HIV Infected Adolescents
NCT ID: NCT00075907
Last Updated: 2013-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
240 participants
INTERVENTIONAL
2004-07-31
2006-09-30
Brief Summary
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Detailed Description
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Patients will be enrolled in this study for 96 weeks and will be randomly assigned into one of two groups. Group 1 will receive LPV/r and 2 NRTIs. Treatment naive patients in Group 1 will have the option of receiving either once-daily dosing or twice-daily dosing of LPV/r. Treatment experienced patients will receive twice-daily dosing of LPV/r. Patients on once-daily dosing of LPV/r who become intolerant to the regimen will be permitted to switch to twice-daily dosing. Group 2 will receive EFV and 2 NRTIs. All patients will be independently and simultaneously randomly assigned to undergo either TDM with subsequent dose adjustment if necessary or no TDM.
Patient medical history and physical exam will be conducted at screening, entry, Weeks 2, 4, 8, every 8 weeks until Week 48, and every 12 weeks thereafter. Blood collection will occur at all study visits. Self-reported pill counts and MEMS TrackCap readings (on LPV/r and EFV bottles) will be noted at most visits. Patients will be asked to complete adherence questionnaires at selected study visits.
Patients enrolled in PACTG 390 (Different Combination Regimens and Treatment-Switching Guidelines in HIV Infected Children 18 Years of Age and Younger) are encouraged to coenroll simultaneously in this study and in PACTG 219C (Long-Term Effects of HIV Exposure and Infection in Children).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Efavirenz + 2 NRTIs
Lopinavir/Ritonavir + 2 NRTIs
Therapeutic Drug Monitoring
Eligibility Criteria
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Inclusion Criteria
* HIV RNA viral load of 10,000 copies/ml or more at screening
* Weigh 35 kg (77.2 lbs) or more
* HAART naive or received a single regimen of combination therapy consisting of NRTIs with or without a single PI (except LPV). Patients who received zidovudine monotherapy during pregnancy or used low-dose ritonavir (RTV) as a PI boost are not excluded.
* For PI experienced patients, have sensitivity to LPV at screening
* Able to receive, as part of background HAART chosen by their physician, at least one new NRTI that is likely to be active against the patient's virus and unlikely to have cross-resistance with previously used NRTIs
* Willing to use acceptable forms of contraception
* Parent or legal guardian willing to provide informed consent, if applicable
Exclusion Criteria
* Require certain medications
* Grade 3 or 4 clinical or laboratory toxicity, as defined by the Division of AIDS Toxicity Table for Grading Severity of Pediatric Adverse Effects
* Chemotherapy for active malignancy
* Acute opportunistic or serious bacterial infection requiring therapy at study entry
* Investigational treatment within 30 days of study entry
* Score of 20 or more on Beck Depression Inventory (BDI-II) or suicidal thoughts on BDI-II (score of 2 or 3 on Question 9), regardless of total score
* Pregnant within 48 hours of starting EFV
* Breastfeeding
13 Years
23 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Margarita Silio, MD
Role: STUDY_CHAIR
Tulane Medical Center
Russell Van Dyke, MD
Role: STUDY_CHAIR
Tulane Medical Center
Locations
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Usc La Nichd Crs
Alhambra, California, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States
Children's Hospital of Los Angeles NICHD CRS
Los Angeles, California, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Chicago Children's CRS
Chicago, Illinois, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
Children's Hosp.
New Orleans, Louisiana, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States
St. Jude/UTHSC CRS
Memphis, Tennessee, United States
Children's Med. Ctr. Dallas
Dallas, Texas, United States
Texas Children's Hosp. CRS
Houston, Texas, United States
Countries
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References
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Eron JJ, Feinberg J, Kessler HA, Horowitz HW, Witt MD, Carpio FF, Wheeler DA, Ruane P, Mildvan D, Yangco BG, Bertz R, Bernstein B, King MS, Sun E. Once-daily versus twice-daily lopinavir/ritonavir in antiretroviral-naive HIV-positive patients: a 48-week randomized clinical trial. J Infect Dis. 2004 Jan 15;189(2):265-72. doi: 10.1086/380799. Epub 2004 Jan 7.
Deschamps AE, Graeve VD, van Wijngaerden E, De Saar V, Vandamme AM, van Vaerenbergh K, Ceunen H, Bobbaers H, Peetermans WE, de Vleeschouwer PJ, de Geest S. Prevalence and correlates of nonadherence to antiretroviral therapy in a population of HIV patients using Medication Event Monitoring System. AIDS Patient Care STDS. 2004 Nov;18(11):644-57. doi: 10.1089/apc.2004.18.644.
Murphy DA, Sarr M, Durako SJ, Moscicki AB, Wilson CM, Muenz LR; Adolescent Medicine HIV/AIDS Research Network. Barriers to HAART adherence among human immunodeficiency virus-infected adolescents. Arch Pediatr Adolesc Med. 2003 Mar;157(3):249-55. doi: 10.1001/archpedi.157.3.249.
Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, Wagener MM, Singh N. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med. 2000 Jul 4;133(1):21-30. doi: 10.7326/0003-4819-133-1-200007040-00004.
Van Dyke RB, Lee S, Johnson GM, Wiznia A, Mohan K, Stanley K, Morse EV, Krogstad PA, Nachman S; Pediatric AIDS Clinical Trials Group Adherence Subcommittee Pediatric AIDS Clinical Trials Group 377 Study Team. Reported adherence as a determinant of response to highly active antiretroviral therapy in children who have human immunodeficiency virus infection. Pediatrics. 2002 Apr;109(4):e61. doi: 10.1542/peds.109.4.e61.
Related Links
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Click here for more information about PACTG 390
Click here for more information about PACTG 219C
Other Identifiers
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DAIDS-ES ID 10043
Identifier Type: -
Identifier Source: secondary_id
PACTG P1034
Identifier Type: -
Identifier Source: org_study_id