Anti-HIV Drug Regimens With or Without Protease Inhibitors and Drug Level Monitoring in HIV Infected Adolescents
A Comparative Trial of Protease-Containing and Protease-Sparing HAART Regimens in HIV-Infected Adolescents With an Evaluation of Therapeutic Drug Monitoring
2 other identifiers
interventional
240
1 country
13
Brief Summary
The purpose of this study is to compare the effectiveness of anti-HIV drug regimens with or without a protease inhibitor (PI) in HIV infected adolescents. It will also determine if monitoring drug levels and adjusting the dose as necessary improves the effectiveness of these regimens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
Started Jul 2004
Shorter than P25 for phase_3 hiv-infections
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2004
CompletedFirst Posted
Study publicly available on registry
January 13, 2004
CompletedStudy Start
First participant enrolled
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedOctober 7, 2013
October 1, 2013
January 9, 2004
October 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients achieving viral suppression (viral load less than 1,000 copies/ml) at Week 24 and maintaining suppression through Week 48 while remaining on study treatment
Secondary Outcomes (11)
Proportion of patients achieving virologic suppression (viral load less than 1,000 copies/ml) at Week 24 and maintaining suppression through Week 96 while remaining on study treatment
adherence measured by MEMS TrackCap Monitors (percentage of doses taken, estimated using the frequency of bottle openings recorded by the MEMS TrackCap Monitors, the MEMS TrackCap Monitor tracking form, and the information recorded on the questionnaires)
adherence measured by patient self-report (binary variable of perfect adherence measured 3 days prior to any study visit reported on the adherence questionnaires and the numbers of visits with reported perfect adherence up to Week 24, 48, and 96)
adherence measured by pill count (percentage of pills taken, determined by counting the pills left in the bottles)
HIV viral load at each study visit
- +6 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- HIV infected
- 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
You may not qualify if:
- Prior receipt of any NNRTI or LPV
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Usc La Nichd Crs
Alhambra, California, 91803, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90806, United States
Children's Hospital of Los Angeles NICHD CRS
Los Angeles, California, 90027, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 80045, United States
Chicago Children's CRS
Chicago, Illinois, 60614, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112, United States
Children's Hosp.
New Orleans, Louisiana, 70118, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, 21287, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, 11794, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457, United States
St. Jude/UTHSC CRS
Memphis, Tennessee, 38105, United States
Children's Med. Ctr. Dallas
Dallas, Texas, 75235, United States
Texas Children's Hosp. CRS
Houston, Texas, 77030, United States
Related Publications (5)
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.
PMID: 14722892BACKGROUNDDeschamps 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.
PMID: 15633262BACKGROUNDMurphy 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.
PMID: 12622674BACKGROUNDPaterson 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.
PMID: 10877736BACKGROUNDVan 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.
PMID: 11927734BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Margarita Silio, MD
Tulane Medical Center
- STUDY CHAIR
Russell Van Dyke, MD
Tulane Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2004
First Posted
January 13, 2004
Study Start
July 1, 2004
Study Completion
September 1, 2006
Last Updated
October 7, 2013
Record last verified: 2013-10