PACTG 1038 LPV-RTV +/- SQV in Treatment-Experienced Children PACTG - PowerPoint PPT Presentation

LPV/r +/- SQV in Treatment-Experienced Children PACTG 1038

LPV-RTV +/- SQV in Treatment-Experienced Children PACTG 1038: Study Design Step 1 Step 2: Wk4 Study Design: PACTG 1038 • Background : Phase I/II, open-label trial to assess the safety and tolerability of high-dose lopinavir- ritonavir (LPV-RTV) with or without saquinavir (SQV) If IQ<15, add in protease inhibitor-experienced children with HIV LPV-RTV BID + SQV BID ≥ 2NRTIs infection (n=21) • Inclusion Criteria (n = 26) - Children aged 2 to 18 years old - On PI therapy for ≥ 6 months - Failing current regimen: HIV RNA >5000 copies/mL LPV-RTV BID + If IG< 15, add - Phenotypic resistance to LPV ≥ 5 times wild-type NNRTI + SQV BID - CD4 count ≥ 50 cells/mm 3 ≥ 2NRTIs (n=5) • Treatment Arms - LPV-RTV 400-100 mg/m 2 + ≥ 2NRTIs à SQV 750 mg/m 2 BID added at week 4 if IQ<15 - LPV-RTV 480-120 mg/m 2 BID + NNRTI + ≥ 2NRTIs à SQV750 mg/m 2 BID added at week 4 if IQ<15 Source: Robbins BL, et al. Antimicrob Agents Chemother. 2008;52:3276-83.

LPV-RTV +/- SQV in Treatment-Experienced Children PACTG 1038: Results Week 48: Virologic Response All study subjects with evaluatable viral loads 100,000 Median HIV RNA (copies/mL) 76,785 80,000 60,000 40,000 28,395 20,000 8492 0 Baseline 24 Weeks 48 Weeks Source: Robbins BL, et al. Antimicrob Agents Chemother. 2008;52:3276-83.

LPV-RTV +/- SQV in Treatment-Experienced Children PACTG 1038: Results Week 48: Immunologic Response All study subjects with evaluatable viral loads 1,000 Median CD4 count (cells/m 3 ) 800 572 600 341 400 262 200 0 Baseline 24 Weeks 48 Weeks Source: Robbins BL, et al. Antimicrob Agents Chemother. 2008;52:3276-83.

LPV/r +/- SQV in Treatment-Experienced Children PACTG 1038: Conclusions Conclusion : “In antiretroviral-experienced children and adolescents with HIV, high doses of LPV/r with or without SQV offer safe options for salvage therapy, but the modest virologic response and the challenge of adherence to a regimen with a high pill burden may limit the usefulness of this approach.” Source: Robbins BL, et al. Antimicrob Agents Chemother. 2008;52(9):3276-83.

Acknowledgment The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program resource funded by the United States Health Resources and Services Administration. The project is led by the University of Washington and the AETC National Coordinating Resource Center. The content in this slide set does not represent the official views of the U.S. Department of Health and Human Services, Health Resources & Services Administration.