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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. Identifier: NCT00102206
Recruitment Status : Completed
First Posted : January 26, 2005
Last Update Posted : November 1, 2021
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)

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Abacavir sulfate Drug: Emtricitabine Drug: Lamivudine Drug: Lopinavir/ritonavir Drug: Saquinavir Drug: Tenofovir disoproxil fumarate Drug: Zidovudine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Tolerability of dual PI-based HAART versus multi-NRTI HAART salvage regimens (time to first intolerant event)
  2. 95% confidence interval (CI) for change in CD4% computed for PI-containing groups versus PI-sparing group
  3. 95% CI for change in BMD (both percent change in BMD and change in z-score from baseline) for each treatment group

Secondary Outcome Measures :
  1. HIV-1 RNA
  2. growth and development markers
  3. toxicity
  4. adherence
  5. pharmacokinetics
  6. special virologic and immunologic parameters

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00102206

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United States, Illinois
Chicago Children's CRS
Chicago, Illinois, United States, 60614
United States, New York
New York, New York, United States
Stony Brook, New York, United States, 11794-8111
United States, North Carolina
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Study Chair: Andrew Wiznia, MD Jacobi Medical Center
Study Chair: Ann J. Melvin, MD, MPH Seattle Children's Hospital and Regional Medical Center
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00102206    
Other Study ID Numbers: P1053
10131 ( Registry Identifier: DAIDS ES )
First Posted: January 26, 2005    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors