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A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00102206
Recruitment Status : Completed
First Posted : January 26, 2005
Last Update Posted : May 21, 2012
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE January 25, 2005
First Posted Date  ICMJE January 26, 2005
Last Update Posted Date May 21, 2012
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2005)
  • Tolerability of dual PI-based HAART versus multi-NRTI HAART salvage regimens (time to first intolerant event)
  • 95% confidence interval (CI) for change in CD4% computed for PI-containing groups versus PI-sparing group
  • 95% CI for change in BMD (both percent change in BMD and change in z-score from baseline) for each treatment group
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Tolerability of dual PI-based HAART versus multi-NRTI HAART salvage regimens (time to first intolerant event)
  • 95% CI for change in CD4% computed for PI-containing groups versus PI-sparing group
  • 95% CI for change in BMD (both percent change in BMD and change in z-score from baseline) for each treatment group
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2005)
  • HIV-1 RNA
  • growth and development markers
  • toxicity
  • adherence
  • pharmacokinetics
  • special virologic and immunologic parameters
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy
Official Title  ICMJE A Phase II, Randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Two Antiretroviral Therapeutic Strategies: A Dual PI-Based HAART Regimen Versus a Multi-NRTI ART Regimen, in ART-Experienced Children and Youth Who Have Experienced Virologic Failure
Brief Summary HIV infected children and adolescents who have taken many anti-HIV drugs may have limited treatment options and are at high risk for progressing to AIDS. The purpose of this study is to determine whether an anti-HIV treatment regimen of 2 protease inhibitors (PIs) and 2 nucleoside reverse transcriptase inhibitors (NRTIs) is more effective than a regimen of 4 NRTIs in treatment-experienced children and adolescents who have failed previous anti-HIV treatment.
Detailed Description

HIV infected children and adolescents on anti-HIV treatment regimens have traditionally had more difficulty with non-adherence and drug resistance than adults, often resulting in virologic failure. Additionally, HIV infected children with extensive exposure to antiretrovirals (ARVs) are likely to have fewer therapeutic options for salvage therapy, and their physicians find it difficult to choose regimens that will keep the HIV infection under control. This study will compare the efficacy of three 4-drug ARV salvage regimens in treatment-experienced, HIV infected children and adolescents who have experienced virologic failure.

This study will last at least 96 weeks. Participants will be randomly assigned to one of three groups. Group 1A will receive a dual-PI based regimen of lopinavir/ritonavir (LPV/r), saquinavir (SQV), and the NRTIs emtricitabine (FTC) and abacavir sulfate (ABC). Group 1B will receive a dual-PI based regimen of LPV/r, SQV, FTC, and tenofovir disoproxil fumarate (TDF). Group 2 will receive an NRTI-only regimen of ABC, lamivudine, zidovudine, and TDF.

There will be 11 study visits during Step I of this study. Medical history, a physical exam, and blood collection will occur at all visits. Dual-energy x-ray absorptiometry (DEXA) scans will occur at study entry and at Weeks 24, 48, 72, and 96. Urine collection will occur at most visits; participants will also take part in adherence modules at most visits. Participants will be asked to complete a pill count form at Weeks 4 and 24. Additionally, some study participants will be asked to participate in an intensive pharmacokinetics study at Week 4.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: Abacavir sulfate
  • Drug: Emtricitabine
  • Drug: Lamivudine
  • Drug: Lopinavir/ritonavir
  • Drug: Saquinavir
  • Drug: Tenofovir disoproxil fumarate
  • Drug: Zidovudine
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2012)
6
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
254
Actual Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria for Step I:

  • HIV infected
  • No currently available therapeutic options that would likely result in long-term suppression of virus to less than 400 copies/ml
  • Two measurements within 4 months prior to screening and at screening of either CD4% of less than 15% and HIV viral load of greater than 10,000 copies/ml OR HIV viral load greater than 30,000 copies/ml
  • Previous exposure to non-nucleoside reverse transcriptase inhibitors (NNRTIs), NRTIs, and PIs AND have experienced virologic failure. More information on previous treatment regimen requirements is available in the protocol.
  • Prior or current virologic failure with genotypic or phenotypic resistance OR historical virologic failure with a PI- or NNRTI-containing regimen
  • Resistance to 2 or more drugs in most recent treatment regimen within 26 weeks prior to study screening
  • Able and willing to swallow study medications
  • Parent or guardian willing to provide informed consent, if applicable
  • Willing to use acceptable methods of contraception

Exclusion Criteria for Step I:

  • Previous cumulative exposure to TDF for more than 24 weeks OR more than 14 days of TDF exposure during the 24 weeks prior to study entry
  • Grade 1 lipase or higher within 28 days prior to study entry
  • Grade 3 or higher laboratory abnormality (except for lipase) within 28 days prior to study entry
  • History of allergy or hypersensitivity to any of the study drugs
  • Active CDC Stage C opportunistic infection or serious bacterial infection requiring therapy at the time of screening
  • Chemotherapy for active cancer
  • Require certain medications
  • Abnormal kidney function
  • Any clinically significant diseases other than HIV infection or findings during medical history screening that, in the opinion of the investigator, may interfere with the study
  • Pregnancy or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT00102206
Other Study ID Numbers  ICMJE P1053
10131 ( Registry Identifier: DAIDS ES )
PACTG P1053
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Study Chair: Andrew Wiznia, MD Jacobi Medical Center
Study Chair: Ann J. Melvin, MD, MPH Seattle Children's Hospital and Regional Medical Center
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP