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

NCT00102206 | Completed Phase 2

• 3 other identifiers: P105310131PACTG P1053
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV Infections

Keywords

Treatment Experienced; Child

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• HIV-1 RNA

• growth and development markers

• toxicity

• adherence

• pharmacokinetics

Interventions

Abacavir sulfate DRUG

Emtricitabine DRUG

Lamivudine DRUG

Lopinavir/ritonavir DRUG

Saquinavir DRUG

Tenofovir disoproxil fumarate DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (4)

Chicago Children's CRS

Chicago, Illinois, 60614, United States

Location

Columbia IMPAACT CRS

New York, New York, United States

Location

SUNY Stony Brook NICHD CRS

Stony Brook, New York, 11794-8111, United States

Location

DUMC Ped. CRS

Durham, North Carolina, 27710, United States

Location

Related Publications (5)

• Brogly S, Williams P, Seage GR 3rd, Oleske JM, Van Dyke R, McIntosh K; PACTG 219C Team. Antiretroviral treatment in pediatric HIV infection in the United States: from clinical trials to clinical practice. JAMA. 2005 May 11;293(18):2213-20. doi: 10.1001/jama.293.18.2213.

  PMID: 15886376 BACKGROUND

• Gavin PJ, Yogev R. The role of protease inhibitor therapy in children with HIV infection. Paediatr Drugs. 2002;4(9):581-607. doi: 10.2165/00128072-200204090-00004.

  PMID: 12175273 BACKGROUND

• Handforth J, Sharland M. Triple nucleoside reverse transcriptase inhibitor therapy in children. Paediatr Drugs. 2004;6(3):147-59. doi: 10.2165/00148581-200406030-00002.

  PMID: 15170362 BACKGROUND

• Neely M, Kovacs A. Management of Antiretroviral Therapy in Neonates, Children, and Adolescents. Curr Infect Dis Rep. 2003 Dec;5(6):521-530. doi: 10.1007/s11908-003-0097-4.

  PMID: 14642195 BACKGROUND

• Piketty C, Race E, Castiel P, Belec L, Peytavin G, Si-Mohamed A, Gonzalez-Canali G, Weiss L, Clavel F, Kazatchkine MD. Efficacy of a five-drug combination including ritonavir, saquinavir and efavirenz in patients who failed on a conventional triple-drug regimen: phenotypic resistance to protease inhibitors predicts outcome of therapy. AIDS. 1999 Jul 30;13(11):F71-7. doi: 10.1097/00002030-199907300-00001.

  PMID: 10449277 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

abacavir; Emtricitabine; Lamivudine; Lopinavir; Saquinavir; Tenofovir; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Dideoxynucleosides; Pyrimidinones; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinolines; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Thymidine

Study Officials

• Andrew Wiznia, MD

  Jacobi Medical Center

  STUDY CHAIR

• Ann J. Melvin, MD, MPH

  Seattle Children's Hospital and Regional Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2005
• First Posted: January 26, 2005
• Study Completion: May 1, 2007
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (4)