Phase 4
Completed N=10
Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens
Source: ClinicalTrials.gov NCT00940771 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Apr 2020
Primary outcomePrimary: Non-fasting Cholesterol — 187.2; 178.5; 181.5 mg/dL — p=.006
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The hypothesis for this study is whether a treatment regimen containing Atazanavir in combination with Ritonavir will work as well as other regimens containing a protease inhibitor and/or a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) at controlling HIV disease in children who are HIV+ and have high cholesterol or high triglycerides. . In this study, children who have high cholesterol or high triglycerides as a result of their HIV medicines, will have the PI or NNRTI in their medication regimen changed to Atazanavir, which is a PI in combination with a low dose of Ritonavir (another PI). Atazanavir has been shown in adults to result in lower cholesterol and triglycerides than other PI's and NNRTI's. The dose of Atazanavir and Ritonavir will be according to the Package Insert for this drug that is FDA approved for children. They will continue taking the other medications from the pre-study regimen. Children will take study drug for 24 weeks, and will be able to continue study drug after the study using commercially available drug. Lab tests and a physical exam will be undertaken at 4 weeks, 12 weeks and 24 weeks after starting study drug to determine how effective the new drug is and to monitor for possible side effects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-fasting Cholesterol |
187.2; 178.5; 181.5 | .006 sig |
| PRIMARY Non-fasting Triglycerides |
240.5; 195.5; 193.3 | .356 |
| SECONDARY Viral Load |
10; 9; 9 | .801 |
| SECONDARY CD4 Count |
1214.3; 1151.9; 1120.0 | .075 |
Eligibility Criteria
Inclusion Criteria
- HIV positive children with elevated lipid levels
- on stable HAART for at least 3 months (defined to be on the same regimen with viral load 10 X ULN)
- Women of Childbearing Potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test.
Data sourced from ClinicalTrials.gov (NCT00940771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.