Changes in insulin resistance after initiation of raltegravir or protease inhibitors with tenofovir-emtricitabine: AIDS Clinical Trials Group A5260s

Citation: Dirajlal-Fargo, S, Moser C, Brown TT, Currier JS, Kelesidis T, Dube MP, Stein JH, Ribaudo HJ, McComsey GA. Changes in insulin resistance after initiation of raltegravir or protease inhibitors with tenofovir-emtricitabine: AIDS Clinical Trials Group A5260s. Open Forum Infect Dis. 2016 Aug 29;3(3):ofw174. eCollection 2016 Sep. PMID: 27704026. PMCID: PMC5047417. 

Access full article:

https://www.ncbi.nlm.nih.gov/pubmed/27704026

Background.

Antiretroviral therapy (ART) can alter glucose metabolism, but little data exist on the association of raltegravir (RAL) with insulin resistance.

Methods 

A5260s was a substudy of A5257, a prospective open-label randomized trial in which human immunodeficiency virus (HIV)-infected treatment-naive participants were randomized to tenofovir-emtricitabine (TDF/FTC) plus atazanavir-ritonavir (ATV/r), darunavir-ritonavir (DRV/r), or RAL over 96 weeks. Baseline and changes in insulin resistance as estimated by the homeostatic model assessment of insulin resistance (HOMA-IR) were assessed. Wilcoxon rank-sum tests were used to assess shifts in the distribution of fold increase from baseline between treatment arms, and Spearman correlation was used to assess associations between HOMA-IR and measures of inflammation and body composition.

Results

Three hundred twenty-eight participants were randomized; 90% were male, baseline median age was 36, HIV ribonucleic acid copies were 4.55 log10 copies/mL, and CD4 cell count was 349/mm3. Overall, HOMA-IR increased significantly after 4 weeks (1.9-fold change; 95% confidence interval, 1.73-2.05) then plateaued over the remainder of the study. Changes in HOMA-IR were not different between the arms (P ≥ .23). Changes in HOMA-IR were associated with changes in body mass index at weeks 48 and 96 (r = 0.12-0.22; P ≤ .04). There was a trend with increases in HOMA-IR and increases in visceral abdominal fat at week 96 (r = 0.12; P = .06). At 48 and 96 weeks, HOMA-IR correlated with interleukin-6, high-sensitivity C-reactive protein, and soluble CD163 (r = 0.16-0.27; P ≤ .003).

Conclusions 

Insulin resistance increased rapidly and then plateaued in treatment-naive participants initiating ART with TDF/FTC, and no differences were found with RAL when compared with ATV/r or DRV/r.

Open Forum Infectious Diseases, 2016, 3(3):ofw174

Categories

CRS
Topics

Clinical Trials

HPTN083: A Phase 2b/3 Double Blind Safety and Efficacy Study...

HPTN 083 is a study being done to evaluate the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for...

Read More

A5300B/I2003B/PHOENIX, Protecting Households On Exposure to...

This study will compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing...

Read More

HPTN 069: A Phase II Randomized, Double-Blind, Study of the...

HPTN 069 is a phase II, four-arm, multisite, randomized, double-blinded trial. To assess the safety and tolerability of four...

Read More

A5128: Consent for Use of Stored Patient Specimens for...

The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood and other...

Read More

A5322: Long-Term Follow-up of Older HIV-infected Adults in...

The A5322 protocol is a long-term observational study, with a planned series of analyses of data to be collected from an...

Read More