Phase 2
Completed N=11
Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir
Source: ClinicalTrials.gov NCT02097108 ↗Enrolled (actual)
11
Serious AEs
9.1%
Results posted
Sep 2016
Primary outcomePrimary: Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction — 90.9 percentage of participants
Summary
This is a 24-week, one arm, open-label, interventional, non-comparative multicenter study to evaluate lipid changes in HIV infected women with hyperlipidemia on boosted PI based regimen after switching their boosted PI to raltegravir at standard dosage with 400mg twice daily.
This study aims to study the effect on metabolic profiles by switching hyperlipidemic HIV infected women from a PI based regimen to raltegravir.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction |
90.9 | — |
| SECONDARY Total Cholesterol Baseline and After 24 Weeks |
247.55; 215.7 | — |
| SECONDARY Triglycerides Baseline and After 24 Weeks |
168.45; 83.3 | — |
| SECONDARY High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks |
58; 64 | — |
Eligibility Criteria
Inclusion Criteria
- Documented HIV-1 infection in female patients, age ≥18 years
- Patients receiving antiretroviral therapy consisting of at least 2 antiretroviral agents other than protease inhibitor plus a ritonavir-boosted protease inhibitor (PI) for at least the previous 6 months
- Plasma HIV viral load 130 mg/dl
- Fasting triglycerides <450 mg/dl
Exclusion Criteria
- History of virological failure during previous antiretroviral therapy
Data sourced from ClinicalTrials.gov (NCT02097108). 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.