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

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Oct 13, 2022 216 likes •295 views

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

SLIDE 1

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

PACTG 1038

SLIDE 2

LPV-RTV +/- SQV in Treatment-Experienced Children

PACTG 1038: Study Design

Source: Robbins BL, et al. Antimicrob Agents Chemother. 2008;52:3276-83. LPV-RTV BID + ≥2NRTIs (n=21) LPV-RTV BID + NNRTI + ≥2NRTIs (n=5)

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) in protease inhibitor-experienced children with HIV infection

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
Phenotypic resistance to LPV ≥5 times wild-type
CD4 count ≥50 cells/mm3
Treatment Arms
LPV-RTV 400-100 mg/m2 + ≥2NRTIs

à SQV 750 mg/m2 BID added at week 4 if IQ<15

LPV-RTV 480-120 mg/m2 BID + NNRTI + ≥2NRTIs

à SQV750 mg/m2 BID added at week 4 if IQ<15

If IQ<15, add SQV BID If IG< 15, add SQV BID

Step 1 Step 2: Wk4

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LPV-RTV +/- SQV in Treatment-Experienced Children

PACTG 1038: Results

Week 48: Virologic Response

Source: Robbins BL, et al. Antimicrob Agents Chemother. 2008;52:3276-83.

76,785 28,395 8492

20,000 40,000 60,000 80,000 100,000

Baseline 24 Weeks 48 Weeks Median HIV RNA (copies/mL) All study subjects with evaluatable viral loads

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LPV-RTV +/- SQV in Treatment-Experienced Children

PACTG 1038: Results

Week 48: Immunologic Response

Source: Robbins BL, et al. Antimicrob Agents Chemother. 2008;52:3276-83.

262 341 572

200 400 600 800 1,000

Baseline 24 Weeks 48 Weeks Median CD4 count (cells/m3) All study subjects with evaluatable viral loads

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

PACTG 1038: Conclusions

Source: Robbins BL, et al. Antimicrob Agents Chemother. 2008;52(9):3276-83.

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

f this approach.”

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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.