Study design and participant characteristics of a randomized controlled trial of directly administered antiretroviral therapy in opioid treatment programs

<p>Abstract</p> <p>Background</p> <p>HIV-infected drug users are at higher risk of non-adherence and poor treatment outcomes than HIV-infected non-drug users. Prior work from our group and others suggests that directly administered antiretroviral therapy (DAART) delivered in opioid treatment programs (OTPs) may increase rates of viral suppression.</p> <p>Methods/Design</p> <p>We are conducting a randomized trial comparing DAART to self-administered therapy (SAT) in 5 OTPs in Baltimore, Maryland. Participants and investigators are aware of treatment assignments. The DAART intervention is 12 months. The primary outcome is HIV RNA < 50 copies/mL at 3, 6, and 12 months. To assess persistence of any study arm differences that emerge during the active intervention, we are conducting an 18-month visit (6 months after the intervention concludes). We are collecting electronic adherence data for 2 months in both study arms. Of 457 individuals screened, a total of 107 participants were enrolled, with 56 and 51 randomly assigned to DAART and SAT, respectively. Participants were predominantly African American, approximately half were women, and the median age was 47 years. Active use of cocaine and other drugs was common at baseline. HIV disease stage was advanced in most participants. The median CD4 count at enrollment was 207 cells/mm³, 66 (62%) had a history of an AIDS-defining opportunistic condition, and 21 (20%) were antiretroviral naïve.</p> <p>Conclusions</p> <p>This paper describes the rationale, methods, and baseline characteristics of subjects enrolled in a randomized clinical trial comparing DAART to SAT in opioid treatment programs.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00279110">NCT00279110</a></p

The effect of isolated nocturnal oxygen desaturations on serum hs‐CRP and IL‐6 in patients with chronic obstructive pulmonary disease

IntroductionA majority of patients with chronic obstructive pulmonary disease (COPD) die of cardiovascular disease (CVD), yet the mechanisms responsible for this association are not fully understood. It remains unknown if isolated nocturnal oxygen desaturation (iNOD) could be one of the potential pathways by which the 'inflammatory COPD' phenotype leads to CVD.ObjectivesWe aimed to evaluate if COPD patients who meet the Medicare guidelines for nocturnal oxygen therapy (iNOT+) had higher serum hs-CRP and IL-6 than those who did not meet the guidelines for iNOT (iNOT-).MethodsPatients with moderate to severe COPD (ie FEV1&nbsp;&lt;&nbsp;80% and FEV1/FVC&nbsp;&lt;&nbsp;70), who were not on oxygen, underwent nocturnal oximetry on room air. Serum IL-6 and hs-CRP were collected the morning after the nocturnal oximetry testing.ResultsA total of 28 patients were included in the study, 8 of whom had more than 5 minutes and 5% of their sleep time spent at oxygen saturation less than 88% and constituted the iNOT+ group. Only serum hs-CRP was significantly higher in iNOT+ than iNOT- (P&nbsp;=&nbsp;0.050). There was no difference in the rate of COPD exacerbations at one and three months, or five-year survival between the groups (P&nbsp;&gt;&nbsp;0.3).ConclusionCOPD patients who have more than 5 minutes and 5% of their sleep time spent at oxygen saturation less than 88% have increased hs-CRP, which is associated with increased risk of future CVD

A pilot randomized aerobic exercise trial in older HIV-infected men: Insights into strategies for successful aging with HIV

<div><p>Background</p><p>HIV-infected adults have increased risk for age-related diseases and low cardiorespiratory fitness that can be prevented and improved with exercise. Yet, exercise strategies have not been well studied in older adults with HIV and may require substantial adaptation to this special population.</p><p>Objective</p><p>To determine the safety and efficacy of aerobic exercise in older HIV-infected men in a randomized trial comparing different levels of exercise intensity.</p><p>Methods</p><p>We conducted a pilot exercise trial in 22 HIV-infected men ≥50 years of age receiving antiretroviral therapy who were randomized 1:1 to moderate-intensity aerobic exercise (Mod-AEX) or high-intensity aerobic exercise (High-AEX) that was performed three times weekly for 16 weeks in a supervised setting. Primary outcome was cardiorespiratory fitness (VO₂peak) measured by treadmill testing. Secondary outcomes were exercise endurance, six-minute walk distance (6-MWD), body composition measured by Dual-energy X-ray absorptiometry (DXA), and fasting plasma levels of lipids and glucose.</p><p>Results</p><p>VO₂peak increased in the High-AEX group (3.6 ±1.2 mL/kg/min, p = 0.02) but not in the Mod-AEX group (0.4 ±1.4 mL/kg/min, p = 0.7) with a significant between group difference (p<0.01). Exercise endurance increased in both the High-AEX group (27 ±11%, p = 0.02) and the Mod-AEX group (11 ±4%, p = 0.04). The 6-MWD increased in both the High-AEX (62 ±18m, p = 0.01) and the Mod-AEX group (54 ±14m, p = 0.01). Changes in VO₂peak and 6-MWD were clinically relevant. There were no serious exercise-related adverse events. Dropouts were similar between group (27% overall) and were related to joint pain.</p><p>Conclusions</p><p>This pilot exercise trial demonstrates that moderate to high-intensity aerobic exercise in older HIV-infected men increases endurance and ambulatory function. However, increased cardiorespiratory fitness was observed only with high-intensity aerobic exercise despite substantial baseline impairment. Future research is needed to determine exercise strategies in older HIV-infected adults that address advanced aging and comorbidity yet are durable and feasible.</p></div

Trial profile.

<p>Trial profile.</p

Characteristics of the study population randomized to high-intensity or moderate-intensity exercise group.

<p>Characteristics of the study population randomized to high-intensity or moderate-intensity exercise group.</p

ASSOCIATION OF 2-MINUTE STEP TEST PERFORMANCE WITH CARDIORESPIRATORY FITNESS IN OLDER ADULTS WITH HIV

BACKGROUND: Cardiorespiratory fitness (CRF) is an independent predictor of mortality yet requires specialized equipment to measure peak oxygen utilization (VO2peak). Identifying alternative tests, which can be conducted in a clinical setting, is a priority for patient populations with substantial impairment in CRF, such as people with HIV (PWH). Our objective was to determine if the two-minute step test (2-MST), conducted by video teleconferencing, predicted VO2peak in PWH. METHODS: Participants were PWH ≥ 50 years of age who were clinically stable and eligible for a telehealth exercise training intervention. Baseline cardiorespiratory exercise test (CPET) was performed on a treadmill using the modified Bruce protocol to measure VO2peak and maximum heart rate (HRmax). Baseline functional performance was measured using video conferencing technology between different VA medical centers and included 2-MST, 10 time sit-to-stand test, arm curl, and 8-foot up and go. The step count on 2-MST was classified as low or high based on the median value (80 steps). Percent of age predicted HRmax (APMHR) was calculated using formula 208 - (0.7 x age). Two-tailed tests of associations were used with values expressed as mean (standard deviation). RESULTS: The 72 participants were 62.8 (6.7) years old, 88% Black, and 95% men. CPET showed VO2peak = 23.4 (5.5) mL/kg/min, treadmill duration =13.6 (3.4) minutes, %APMHR=95(8)%, and RER= 1.12 (0.11). Based on Pearson’s correlation, the number of steps in 2-MST was associated with VO2peak (r=0.44, p\u3c0.001) and time on treadmill (r=0.48, p\u3c0.001). 2-MST also correlated with other functional performance measures (p-values \u3c0.01) and age (r= -0.43, p\u3c0.001). There was a significant difference in VO2peak between participants with 2-MST classified as low (n=36) versus high (n=37) (mean (SD) ml/min/kg: 21.6 (5.3) vs. 25.0 (5.1), p\u3c0.01). Age adjusted linear regression showed 2-MST predicted VO2peak (beta (95%CI)= 0.065 (0.008,0.123), p=0.027). CONCLUSIONS: Our findings demonstrated that performance in the 2-MST conducted by video conferencing is significantly associated with CRF, independent of age in PWH. The difference in VO2peak between low and high number of steps is approximately 1 MET, suggesting a clinically meaningful difference. In telehealth or space-limited settings, the 2-MST should be considered as an estimate of CRF in older patient populations with reduced fitness. Grant or funding information: VA Office of Research and Development (ORD), Rehabilitation Research and Development, I01 RX002790 (Oursler/Ryan/Marconi

Directly administered antiretroviral therapy for HIV-infected individuals in opioid treatment programs: results from a randomized clinical trial.

Data regarding the efficacy of directly administered antiretroviral therapy (DAART) are mixed. Opioid treatment programs (OTPs) provide a convenient framework for DAART. In a randomized controlled trial, we compared DAART and self-administered therapy (SAT) among HIV-infected subjects attending five OTPs in Baltimore, MD.HIV-infected individuals attending OTPs were eligible if they were not taking antiretroviral therapy (ART) or were virologically failing ART at last clinical assessment. In subjects assigned to DAART, we observed one ART dose per weekday at the OTP for up to 12 months. SAT subjects administered ART at home. The primary efficacy comparison was the between-arm difference in the average proportions with HIV RNA <50 copies/mL during the intervention phase (3-, 6-, and 12-month study visits), using a logistic regression model accounting for intra-person correlation due to repeated observations. Adherence was measured with electronic monitors in both arms.We randomized 55 and 52 subjects from five Baltimore OTPs to DAART and SAT, respectively. The average proportions with HIV RNA <50 copies/mL during the intervention phase were 0.51 in DAART and 0.40 in SAT (difference 0.11, 95% CI: -0.020 to 0.24). There were no significant differences between arms in electronically-measured adherence, average CD4 cell increase from baseline, average change in log10 HIV RNA from baseline, opportunistic conditions, hospitalizations, mortality, or the development of new drug resistance mutations.In this randomized trial, we found little evidence that DAART provided clinical benefits compared to SAT among HIV-infected subjects attending OTPs.ClinicalTrials.gov NCT00279110 NCT00279110&quest;term&hairsp;&equals;&hairsp;NCT00279110&rank&hairsp;&equals;&hairsp;1

Greater Depressive Symptoms and Higher Viral Load Are Associated with Poor Physical Function among Latino Men Living with HIV

Physical function limitations have been associated with poor health outcomes, which have a negative impact on quality of life of older individuals. This study examined the association between depression, viral load, and acculturation with physical function among Latino men living with HIV. A secondary data analysis was performed using a cross-sectional data of 146 Latino immigrant men living with HIV in New York City and Washington, DC. Physical function was measured using the Short-Form Health Survey (SF-12). Uncontrolled HIV infection and depression were associated with worse physical function, thus implying the importance of adequate health care to address these conditions. Preserving physical function should start during middle adulthood, particularly among people living with HIV because of their greater risk of developing age-related challenges such as depression, diabetes, cardiovascular diseases among others. This study informs future interventions to preserve physical function and achieve the goal of successful aging