Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir

Arbeitsgemeinschaft medikamentoese Tumortherapie

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: Raltegravir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02097108

AGMT_HIV1

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 <50 copies/ml on current boosted PI containing regimen for ≥ 6 months prior to study entry
• Fasting LDL cholesterol >130 mg/dl
• Fasting triglycerides <450 mg/dl

Exclusion criteria

• History of virological failure during previous antiretroviral therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Raltegravir

Other group

Description:

Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.

Treatment:

Drug: Raltegravir