Phase 2 Completed N=30 Randomized Treatment

A Study to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Patients

Human Immunodeficiency Virus 1

Source: ClinicalTrials.gov NCT01391013 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2013

Primary outcomePrimary: Change From Baseline to Week 24 in Brachial Artery Flow Mediated Vasodilatation (FMD): Median Change in FMD (%) — -4.8; -0.6 Percentage of brachial artery diameter — p=0.08

Summary

The purpose of this study is to compare change of brachial artery flow mediated vasodilatation using Darunavir/Ritonavir (DRV/r) 800/100 mg once daily as a monotherapy (use of a single medication) versus a triple combination therapy containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) and DRV/r in Human immunodeficiency virus-1 (HIV-1) infected participants.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 24 in Brachial Artery Flow Mediated Vasodilatation (FMD): Median Change in FMD (%)	-4.8; -0.6	0.08
SECONDARY Change From Baseline to Week 48 in Brachial Artery FMD: Median Change in FMD (%)	-4.4; -3	0.88
SECONDARY Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL	0; 0; 1; 0; 0; 0	0.31
SECONDARY Change From Baseline to Week 48 in Circulating Endothelial Cells	5.09; 14.6; 37; 64	0.37
SECONDARY Change From Baseline to Week 48 in Precursors of Circulating Endothelial Cells	16; 18; 120; 108	0.66
SECONDARY Change From Baseline in Mean Low-density Lipoprotein (LDL) Cholesterol at Week 24 and Week 48: Median Change in LDL	17; 6; 14; 5	0.02 sig
SECONDARY Change From Baseline in Mean High-density Lipoprotein (HDL) Cholesterol at Week 24 and Week 48: Median Change in HDL	-1; -6; -4; -6	0.12
SECONDARY Change From Baseline in Mean Triglycerides at Week 24 and Week 48: Median Change in Triglycerides	15; -1; 24; 6	0.71
SECONDARY Change From Baseline in Insulin Sensitivity at Week 24 and Week 48: Median Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	-0.2; -0.3; -0.6; -0.5	0.83
SECONDARY Change From Baseline in Mean Framingham Risk Score at Week 24 and Week 48: Medican Change in Framingham Risk Score	0; 0; 1; 1	0.66
SECONDARY Change From Baseline to Week 48 in Leg Fat Content: Median Change in Leg Fat (Total)	-57; -288	0.76
SECONDARY Change From Baseline to Week 48 in Visceral Fat Content in Abdomen: Median Change in Visceral Abdominal Tissue (VAT)	-4; -4	0.56
SECONDARY Change From Baseline to Week 48 in Femoral Neck T Score: Median Change in Femoral Neck T Score	0.2; -0.1	0.11
SECONDARY Change From Baseline to Week 48 in Femoral Neck Z Score: Median Change in Femoral Neck Z Score	0.2; 0.0	0.18
SECONDARY Change From Baseline to Week 48 in Lumbar T Score: Median Change in Lumbar T Score	0.1; 0.0	0.03 sig
SECONDARY Change From Baseline to Week 48 in Lumbar Z Score: Median Change in Lumbar Z Score	0.1; 0.0	0.04 sig
SECONDARY Change From Baseline in Cluster of Differentiation 4 (CD4) Count Over Week 48	6; -12; 100.1; 60	—

Eligibility Criteria

Inclusion Criteria: - Human immunodeficiency virus-1 (HIV-1) infected participants on their first-line treatment with highly active antiretroviral therapy (HAART) (combination of 2 or 3 nucleoside reverse transcriptase inhibitors [NRTIs] with at least 1 additional antiretroviral [ARV] from the non-nucleoside reverse transcriptase inhibitor [NNRTI] and/or protease inhibitors [PI] class) for at least 24 weeks, provided the same ARV combination for at least 8 weeks before screening

Participants' preference for a more convenient regimen and/or any current or history of toxicity on actual regimen
Plasma HIV-1 ribonucleic acid (RNA) less than 50 cp/ml for at least 24 weeks before screening, where single viral blips of more than 50 copies/mL are allowed
Cluster of differentiation 4 (CD4) count more than 100/mm3 at the start of HAART and more than 200/mm3 at screening
Healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram performed at screening
Agrees to protocol-defined use of effective contraception
Postmenopausal, surgically sterile, or abstinent female participants

Exclusion Criteria

History of coronary heart disease, uncontrolled hypertension, peripheral vascular disease and or cerebrovascular disease
History of virological failure on highly active antiretroviral therapy, plasma HIV-1 ribonucleic acid more than 500 copies/mL after initial full virological suppression while on ARV therapy and any PI mutations
Participants with significantly hepatic and liver insufficiency or diagnosed with acute viral hepatitis or have active clinically significant diseases and acquired immune deficiency syndrome (AIDS) defining illness at screening
Current significant tobacco use, active drug or alcohol use or dependence
Use of lipid-lowering drugs within 4 weeks prior to study entry and use of testosterone, anabolic steroids, oral contraceptives or hormonal replacement within 12 weeks prior to study entry or previous or current use of darunavir
Use of systemic glucocorticoids, long-acting inhaled steroids (inhaled via mouth or nose), or other immunomodulators within 30 days prior to study entry

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01391013). 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.