scholarly journals Association of Suboptimal Antiretroviral Therapy Adherence With Inflammation in Virologically Suppressed Individuals Enrolled in the SMART Study

2017 ◽  
Vol 5 (1) ◽  
Author(s):  
Jose R Castillo-Mancilla ◽  
Andrew N Phillips ◽  
James D Neaton ◽  
Jacqueline Neuhaus ◽  
Simon Collins ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Confidence Interval ◽  
Cohort Studies ◽  
Plasma Concentrations ◽  
Virologic Suppression ◽  
Art Adherence ◽  
Antiretroviral Therapy Adherence ◽  
Smart Study ◽  
Hiv 1 ◽  
D Dimer

Abstract Suboptimal (ie, <100%) antiretroviral therapy (ART) adherence has been associated with heightened inflammation in cohort studies, even among people with virologic suppression. We aimed to evaluate this association among participants in the Strategies for Management of Antiretroviral Therapy (SMART) study who had virologic suppression (HIV-1 VL < 200 copies/mL) at enrollment. Based on self-reported adherence (7-day recall), plasma concentrations of interleukin 6 and D-dimer were 9% (95% confidence interval [CI], 1%–18%; P = .02) and 11% (95% CI, 1%–22%; P = .03) higher in participants who reported suboptimal vs 100% adherence, respectively. These findings confirm previous observations and support the hypothesis that suboptimal ART adherence, even in the context of virologic suppression, may have significant biological consequences. ClinicalTrials.gov number NCT00027352

Intracranial hypertension and papilloedema as a complication to low antiretroviral therapy adherence in a man living with chronic HIV

2021 ◽  
Vol 14 (3) ◽  
pp. e237504
Author(s):  
Rosa Maja Møhring Gynthersen ◽  
Helene Mens ◽  
Marianne Wegener ◽  
Neval Ete Wareham
Keyword(s):  
Antiretroviral Therapy ◽  
Intracranial Pressure ◽  
Intracranial Hypertension ◽  
Idiopathic Intracranial Hypertension ◽  
Ventricular Volume ◽  
Art Adherence ◽  
Hiv Viral Load ◽  
Blurred Vision ◽  
Antiretroviral Therapy Adherence ◽  
Acute Retroviral Syndrome

We describe a 61-year-old man living with HIV on antiretroviral therapy (ART), who presented with headache, dizziness and blurred vision. Latest CD4+ cell count 3 months prior to admission was 570×106 cells/mL and HIV viral load <20 copies/mL. The patient was diagnosed with cerebrospinal fluid (CSF) lymphocytic pleocytosis, raised intracranial pressure and papilloedema. Neuroimaging showed normal ventricular volume and no mass lesions, suggesting (1) neuroinfection (2) idiopathic intracranial hypertension or (3) retroviral rebound syndrome (RRS) as possible causes. Neuroinfection was ruled out and idiopathic intracranial hypertension seemed unlikely. Elevated plasma HIV RNA level was detected consistent with reduced ART adherence prior to admission. RRS is a virological rebound after ART interruption, which can mimic the acute retroviral syndrome of acute primary infection. To the best of our knowledge, we describe the second case of RRS presenting as CSF lymphocytic pleocytosis and elevated intracranial pressure after low ART adherence.

scholarly journals Recruitment of Youth Living With HIV to Optimize Adherence and Virologic Suppression: Testing the Design of Technology-Based Community Health Nursing to Improve Antiretroviral Therapy (ART) Clinical Trials (Preprint)

2020 ◽  
Author(s):  
Allison Lorna Agwu ◽  
Hasiya Eihuri Yusuf ◽  
Lawrence D'Angelo ◽  
Mobeen Rathore ◽  
Jeanette Marchesi ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Antiretroviral Therapy ◽  
Community Health ◽  
Control Group ◽  
Virologic Suppression ◽  
Art Adherence ◽  
Term Survival ◽  
Community Health Nursing ◽  
Health Nursing

BACKGROUND Despite advances in HIV diagnosis and treatment, adolescents and young adults 12-25 years old have high HIV incidence, poor engagement and retention in treatment, and low rates of adherence and virologic suppression when compared to their older counterparts. HIV has emerged as a chronic disease for which antiretroviral therapy (ART) adherence is critical for virologic suppression and long-term survival. Virologic suppression has been elusive for many youth with HIV (YHIV). Novel strategies designed to facilitate health care systems’ support for YHIV between medical visits are essential for improving ART adherence, virologic suppression, and long-term survival. OBJECTIVE The aim of this study is to compare the effectiveness of a technology-enhanced community health nursing intervention (TECH2CHECK) to a standard of care (SOC) control group for improving ART adherence and subsequent viral suppression using a randomized trial design. The objectives are to assess the feasibility, acceptability, and cost-effectiveness of TECH2CHECK as compared to SOC for management of HIV in the outpatient setting and to examine the sustainability of self-care behavior, adherence, and virologic suppression among youth following the intervention period. METHODS We will recruit 120 adherence-challenged YHIV being followed at clinics specializing in HIV care in the Baltimore-Washington metropolitan area and in Jacksonville. Eligible participants complete an audio, computer-assisted self-interview and are randomized to either TECH2CHECK intervention or the SOC (60 participants in each arm). The primary outcome of interest is virologic suppression (viral load &lt;20 copies/mL) and improved treatment adherence. Participants in the intervention arm receive community health nursing visits at 2 weeks, 6 weeks, 10 weeks, 14 weeks, and 26 weeks. The intervention arm also receives SMS messaging comprising daily adherence and appointment reminders and positive reinforcement for medication adherence daily for 2 weeks, on alternate days for 2 weeks, thrice weekly for 1 month, weekly for 3 months, and every 2 weeks for the rest of the study duration. The control group receives appointment reminders and SOC per clinic protocol. Exploratory analysis will be conducted to determine differences in medication adherence and virologic suppression in the 2 arms and to assess cost-effectiveness and study feasibility and acceptability. RESULTS In the first 23 months of the study (July 2018-April 2020), 56 (55%) of 102 eligible patients were enrolled and randomized. At present, participating youths are primarily African American (53/56, 95%), male (37/56, 66%), and ≥18 years old (53/56, 95%). Follow-up study visits, as required per the protocol, have been completed by 77% (43/56), 94% (45/48), 95% (37/39), 96% (24/25), and 100% (10/10) of participants at the 1-month, 3-month, 6-month, 12-month, and 18-month follow-ups, respectively. CONCLUSIONS Preliminary accrual and retention data suggest that TECH2CHECK is feasible and acceptable. CLINICALTRIAL ClinicalTrials.gov NCT03600103 https://clinicaltrials.gov/ct2/show/NCT03600103 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/23480

scholarly journals A Randomized Switch From Nevirapine-Based Antiretroviral Therapy to Single Tablet Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate in Virologically Suppressed Human Immunodeficiency Virus-1-Infected Rwandans

2016 ◽  
Vol 3 (3) ◽  
Author(s):  
Sean E. Collins ◽  
Philip M. Grant ◽  
Francois Uwinkindi ◽  
Annie Talbot ◽  
Eric Seruyange ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Antiretroviral Therapy ◽  
Tenofovir Disoproxil Fumarate ◽  
Sub Saharan Africa ◽  
Current Therapy ◽  
Virologic Suppression ◽  
Open Label ◽  
Immunodeficiency Virus ◽  
Sub Saharan ◽  
Hiv 1

Abstract Background.  Many human immunodeficiency virus (HIV)-infected patients remain on nevirapine-based antiretroviral therapy (ART) despite safety and efficacy concerns. Switching to a rilpivirine-based regimen is an alternative, but there is little experience with rilpivirine in sub-Saharan Africa where induction of rilpivirine metabolism by nevirapine, HIV subtype, and dietary differences could potentially impact efficacy. Methods.  We conducted an open-label noninferiority study of virologically suppressed (HIV-1 ribonucleic acid [RNA] &lt; 50 copies/mL) HIV-1-infected Rwandan adults taking nevirapine plus 2 nucleos(t)ide reverse-transcriptase inhibitors. One hundred fifty participants were randomized 2:1 to switch to coformulated rilpivirine-emtricitabine-tenofovir disoproxil fumarate (referenced as the Switch Arm) or continue current therapy. The primary efficacy endpoint was HIV-1 RNA &lt; 200 copies/mL at week 24 assessed by the US Food and Drug Administration Snapshot algorithm with a noninferiority margin of 12%. Results.  Between April and September 2014, 184 patients were screened, and 150 patients were enrolled; 99 patients switched to rilpivirine-emtricitabine-tenofovir, and 51 patients continued their nevirapine-based ART. The mean age was 42 years and 43% of participants were women. At week 24, virologic suppression (HIV-1 RNA level &lt;200 copies/mL) was maintained in 93% and 92% in the Switch Arm versus the continuation arm, respectively. The Switch Arm was noninferior to continued nevirapine-based ART (efficacy difference 0.8%; 95% confidence interval, −7.5% to +12.0%). Both regimens were generally safe and well tolerated, although 2 deaths, neither attributed to study medications, occurred in participants in the Switch Arm. Conclusions.  A switch from nevirapine-based ART to rilpivirine-emtricitabine-tenofovir disoproxil fumarate had similar virologic efficacy to continued nevirapine-based ART after 24 weeks with few adverse events.

scholarly journals 2513. The Effect of Treatment Supporter Interventions on ART Adherence in Eastern and Southern Africa: a systematic review and meta-analysis

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S872-S873
Author(s):  
Ya Haddy Sallah ◽  
Thabani Nyoni ◽  
Kim Lipsey
Keyword(s):  
Cohort Studies ◽  
Southern Africa ◽  
Meta Analysis ◽  
Standard Of Care ◽  
Cochrane Library ◽  
Virologic Suppression ◽  
Art Adherence ◽  
Meta Regression ◽  
Eastern And Southern Africa ◽  
Study Type

Abstract Background Access to ART has significantly reduced morbidity and mortality and improved quality of life in people living with HIV (PLWH). Treatment supporter interventions (TSIs) utilize patient or facility selected individuals to increase optimal ART adherence through home visits, peer support and medication management. This aim of this meta-analysis is to evaluate the effectiveness of TSIs in improving optimal ART adherence among PLWH in SSA using process- and outcome-oriented measures. Methods We searched PubMed, EMBASE, SCOPUS, Web of Science (WOS), Cochrane Library, and ClinicalTrials.gov for randomized controlled trials or cohort studies comparing treatment supporter interventions to the standard of care conducted in Eastern and Southern Africa. The primary outcomes were ART adherence measured by pill counts and virologic suppression. Pooled risk ratios with 95% confidence intervals were calculated using random-effects models. Stratified analyses and meta-regression were conducted to determine the effect of study type and patient nomination of treatment supporters on ART adherence. Results Sixteen studies, 10 RCTs and 6 cohort studies, were selected for inclusion. Virologic suppression was reported in 14 studies with 12,457 individuals in TSIs and 23,592 receiving the standard of care. Optimal ART adherence was reported in 7 RCTs only (2,185 individuals in TSI and 1,545 receiving SOC). Optimal ART adherence was 7.6% higher in TSIs compared with SOC (pooled RR 1.076, 95% CI 1.005–1.151, p = 0.035). Heterogeneity of these studies was high (I2 = 91.1%). Virologic suppression was 5% higher in TSIs compared with the standard of care (pooled RR 1.05, 95% CI 1.019–1.081, P = 0.001). Meta-regression demonstrated that virologic suppression did not significantly vary by study type (b = −0.042, 95% CI −0.09–0.001, P = 0.057) and patient selection of the treatment supporter (b = 0.026, 95% CI −0.07–0.12, P = 0.554). Conclusion Optimal ART adherence is marginally higher in treatment supporter interventions compared with the standard of care. Patient-nominated supporters achieve similar rates of virologic suppression to facility-selected supporters, and could play a critical role in addressing disparities in health outcomes among PLWH. Disclosures All authors: No reported disclosures.

scholarly journals Decreased Seroreactivity in Individuals Initiating Antiretroviral Therapy during Acute HIV Infection

2019 ◽  
Vol 57 (10) ◽  
Author(s):  
Mark M. Manak ◽  
Linda L. Jagodzinski ◽  
Ashley Shutt ◽  
Jennifer A. Malia ◽  
Mike Leos ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Hiv Infection ◽  
Western Blot ◽  
Research Collaboration ◽  
Virologic Suppression ◽  
Infection Status ◽  
Acute Hiv Infection ◽  
Western Blot Assay ◽  
Acute Hiv ◽  
Hiv 1

ABSTRACTAntiretroviral therapy (ART) during acute HIV infection (AHI) interrupts viral dynamics and may delay the emergence of serological markers targeted by current HIV screening and confirmatory assays, thus creating challenges for correctly classifying HIV infection status. The performance of three HIV antigen/antibody combination (HIV Ag/Ab Combo) assays (the Bio-Rad GS, Abbott Architect, and Bio-Rad BioPlex 2200 assays) was evaluated with samples collected from RV254/South East Asia Research Collaboration in HIV 010 (RV254/SEARCH010) study (Bangkok, Thailand) participants at weeks 12 and 24 following the initiation of ART at Fiebig stage I (FI) (n = 23), FII (n = 39), or FIII/IV (n = 22). Supplemental, confirmatory testing was performed by the Geenius HIV 1/2 and HIV-1 Western blot assays (Bio-Rad). Samples from 30 untreated, HIV-1-infected individuals demonstrated robust HIV Ag/Ab Combo assay reactivity with well-developed HIV-1 Western blotting profiles by 24 weeks after infection. In contrast, 52.2% of samples from individuals initiating ART at FI, 7.7% of samples from individuals initiating ART at FII, and 4.5% of samples from individuals initiating ART at FIII/IV were nonreactive by the HIV Ag/Ab Combo assays, with 36.4 to 39.1% of samples having low signal-to-cutoff (S/CO) results by the Architect and BioPlex assays (S/CO < 10). Seroreversion from a reactive to a nonreactive status was observed in 10 individuals initiating ART at FII and 3 individuals initiating ART at FIII/IV. The Geenius and HIV-1 Western blot assay results were negative or indeterminate for 73.9% and 69.6% of individuals, respectively, treated at FI; 50.0% and 26.3% of individuals, respectively, treated at FII; and 54.5% and 40.9% of individuals, respectively, treated at FIII/IV. Virologic suppression of HIV-1 by ART during AHI impedes seroconversion to biomarkers of infection, limiting the utility of HIV Ag/Ab Combo and supplemental, confirmatory assays for infection status determination.

scholarly journals Active cocaine use is associated with lack of HIV-1 virologic suppression independent of nonadherence to antiretroviral therapy: Use of a rapid screening tool during routine clinic visits

AIDS Care ◽  
2012 ◽  
Vol 25 (1) ◽  
pp. 109-117 ◽  
Author(s):  
Daniel A. Rasbach ◽  
Andrew J. Desruisseau ◽  
Aaron M. Kipp ◽  
Samuel Stinnette ◽  
Asghar Kheshti ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Screening Tool ◽  
Rapid Screening ◽  
Virologic Suppression ◽  
Cocaine Use ◽  
Hiv 1 ◽  
Clinic Visits

scholarly journals The Comparison of Teen Clubs vs. Standard Care on Treatment Outcomes for Adolescents on Antiretroviral Therapy in Windhoek, Namibia

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Farai K. Munyayi ◽  
Brian E. van Wyk
Keyword(s):  
Antiretroviral Therapy ◽  
Treatment Outcomes ◽  
Standard Care ◽  
Psychosocial Support ◽  
Peer Group ◽  
Cohort Analysis ◽  
Hiv Disclosure ◽  
Virologic Suppression ◽  
Art Adherence ◽  
Adherence Support

Background. Adolescents living with HIV (ALHIV) are challenged to adhere to antiretroviral therapy (ART) and achieve and maintain virologic suppression. Group-based adherence support interventions, such as adherence clubs, have been shown to improve long-term adherence in ART patients. The teen club intervention was introduced in 2010 in Namibia to improve treatment outcomes for ALHIV by providing adherence support in a peer-group environment. Adolescents who have completed the full HIV disclosure process can voluntarily join the teen clubs. The current study compared treatment outcomes of ALHIV receiving ART at a specialized paediatric HIV clinic between 1 July 2015 and 30 June 2017 in Windhoek, Namibia. Methods. A retrospective cohort analysis was conducted on routine patient data extracted from the electronic Patient Monitoring System, individual Patient Care Booklets, and teen club attendance registers. A sample of 385 adolescents were analysed: 78 in teen clubs and 307 in standard care. Virologic suppression was determined at 6, 12, and 18 months from study start date, and compared by model of care, age, sex, disclosure status, and ART regimen. Comparisons between adolescents in teen clubs and those receiving standard care were performed using the chi-square test, and risk ratios were calculated to analyze differences in ART adherence and virologic suppression. Results. The average clinician-measured ART adherence was 89% good, 6% fair, and 5% poor amongst all adolescents, with no difference between teen club members and adolescents in standard care ( p  = 0.277) at 3 months. Virologic suppression over the 2-year observation period was 87% (68% fully suppressed <40 copies/ml and 19% suppressed between 40–999 copies/ml), with no difference between teen club members and those in standard care. However, there were statistically significant differences in virologic suppression levels between the younger (10–14 years) adolescents and older (15–19 years) adolescents at 6 months ( p  = 0.015) and at 12 months ( p  = 0.021) and between adolescents on first-line and second-line ART regimen at 6 months ( p  = 0.012), 12 months ( p  = 0.004), and 18 months ( p  = 0.005). Conclusion. The teen club model delivering psychosocial support only did not improve adherence and virologic suppression levels for adolescents in a specialized paediatric ART clinic, neither were they inferior to standard care. Considering the limitations of this study, teen clubs may still hold potential for improving adherence and virologic suppression levels for older adolescents, and more robust research on adherence interventions for adolescents with higher methodological quality is required.

scholarly journals Antiretroviral Therapy Adherence Level and Associated Factors Among HIV/AIDS Patients in Jimma Zone Government Health Facilities, ART Clinics, South-west Ethiopia

2019 ◽  
Vol 5 (5) ◽  
pp. 331
Author(s):  
Aregash Hassen ◽  
Yasmin Mohammed
Keyword(s):  
Antiretroviral Therapy ◽  
Associated Factors ◽  
Health Facilities ◽  
Art Adherence ◽  
Adherence Behavior ◽  
Therapy Adherence ◽  
Strict Adherence ◽  
Antiretroviral Therapy Adherence ◽  
Jimma Zone ◽  
Hiv Aids

Optimal and strict adherence to Antiretroviral Viral Therapy a need for over the long period to achieve the goals of ART and obtain maximum benefits of ART. However, PLWHA find it very difficult to take ARVs drug as precisely as they should for a number of reasons. Therefore, this study aimed at examining the level of antiretroviral therapy adherence and identifying possible associated factors for ART adherence behavior in Jimma zone government ART facilities. A facility based cross-sectional study was  conducted in the ART clinics of Jimma zone governmental health facilities in which ARV treatment supplied from November 25/2015 – February 30/2016 for a period of 4 months. 352 adult PLWHA (190 female and 162 male) ranged in age from 15-62 years (Mean=37.1, SD= 8.95), with 100% response rate, were our study participants. Binary logistic regression was used to perform bivariate and multivariate analyses to determine the association between study variables and ART adherence status. 259(73.6%) participants were adherent (>=95%) and 93(26.4%) were non-adherent (<95%) to the prescribed dose of ARV drugs over the past seven days prior to the interview. The main reasons for skipping the prescribed ARV drugs were, busyness (78.5%), having too many pills (71%), felt depressed (68.8%), taking the drugs reminded HIV infected (66.7%), did not want other see (62.4%), and felt asleep(60.2%). The last stepwise regression analysis revealed that, educational status, knowledge of HIV/AIDS, use of additional drugs and access to reliable pharmacy were significantly associated with ART adherence status. So, efforts to maximize ART adherence should focus on addressing these associated significant factors.

Abstract 350: Influence of HIV-1 Infection and Antiretroviral Therapy on the Coagulation System

2013 ◽  
Vol 33 (suppl_1) ◽  
Author(s):  
Kevin Fasing ◽  
Brian R Weil ◽  
Kyle J Diehl ◽  
Jared J Greiner ◽  
Brian L Stauffer ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Factor Viii ◽  
Tissue Factor ◽  
Plasma Concentrations ◽  
Tissue Type ◽  
Factor Vii ◽  
Coagulation System ◽  
Factor X ◽  
Thrombotic Risk ◽  
Hiv 1

HIV-1-infected individuals have a two- to four-fold greater incidence of cardiovascular disease and atherothrombotic events compared with the general population. The mechanisms responsible for this heightened cardiovascular risk are not fully understood. We have previously reported that the capacity of the endothelium to release tissue-type plasminogen activator (t-PA), the primary activator of fibrinolysis and a key endogenous defense mechanism against intravascular fibrin deposition and thrombosis, is impaired in HIV-1-seropositive adults. Whether diminished fibrinolytic activity is coupled with a hypercoagulative state in this population is unknown. Elevations in specific coagulation markers such as tissue factor and Factor VII are associated with increased thrombotic risk. The experimental aim of this study was to determine the influence of HIV-1 infection and antiretroviral therapy (ART) on markers of coagulation. To address this aim we studied 33 men: 16 HIV-1-seronegative (age: 41±3 yr); 7 HIV-1-seropositive treatment-naïve (34±2 yr); and 10 HIV-1-seropositive receiving ART (42±3 yr; efavirenz-based regimen). All subjects were non-obese, normotensive and free of overt cardiometabolic disease. Circulating concentrations of tissue factor, Factor VII, Factor VIII and Factor X were determined by immunoassay. There were no significant differences in plasma concentrations of tissue factor (32+3 vs 40+3 pg/mL), Factor VII (103+9 vs 100+5 %), Factor VIII (111+13 vs 117+8 %) and Factor X (89+5 vs 91+2 %) between HIV-1-seropositive treatment-naïve and healthy men. Moreover, there was no influence of ART on these circulating markers. Plasma tissue factor (41+5 pg/mL), Factor VII (107+6 %), Factor VIII (103+7 %) and Factor X (90+3%) were similar in the HIV-1-seropositive receiving ART compared with HIV-1-seropositive treatment-naïve and seronegative groups. These data suggest that neither HIV-1 infection per se nor ART are associated with unfavorable changes in specific coagulation markers. Thus, changes in the coagulation system that have been linked to increased thrombotic burden are not apparent in HIV-1-seropositive adults.

scholarly journals Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the Microbicide Trials Network-020 Phase III Trial of the Dapivirine Vaginal Ring

2018 ◽  
Vol 69 (3) ◽  
pp. 523-529 ◽  
Author(s):  
Sharon A Riddler ◽  
Jennifer E Balkus ◽  
Urvi M Parikh ◽  
John W Mellors ◽  
Carolyne Akello ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Disease Progression ◽  
Virologic Failure ◽  
Vaginal Ring ◽  
Phase Iii ◽  
Virologic Suppression ◽  
Cell Counts ◽  
The Impact ◽  
Hiv 1

Abstract Background A vaginal ring containing dapivirine, a non-nucleoside human immunodeficiency virus (HIV)-1 reverse transcriptase inhibitor (NNRTI), was safe and effective in preventing HIV-1 infection in African women. We examined the impact of dapivirine ring use at the time of HIV-1 acquisition on subsequent HIV-1 disease progression and responses to NNRTI-containing antiretroviral therapy (ART). Methods HIV-1 disease progression and virologic failure following initiation of ART were assessed among women who acquired HIV-1 while participating in Microbicide Trials Network–020, a randomized, placebo-controlled trial of a monthly, dapivirine vaginal ring. Results Among the 158 participants who acquired HIV-1 (65 dapivirine, 93 placebo), no differences between dapivirine and placebo participants were observed in CD4+ cell counts or plasma HIV-1 RNA over the first year after infection (prior to ART). During follow-up, 100/158 (63%) participants initiated NNRTI-containing ART (dapivirine: 39/65; placebo: 61/93); the median time to HIV-1 RNA <200 copies/ml was approximately 90 days for both dapivirine and placebo ring recipients (log-rank P = .40). Among the 81 participants with at least 6 months of post-ART follow-up, 19 (24%) experienced virologic failure (dapivirine: 6/32, 19%; placebo: 13/39, 27%; P = .42). Conclusions The acquisition of HIV-1 infection during dapivirine or placebo treatment in ASPIRE did not lead to differences in HIV-1 disease progression. After the initiation of NNRTI-containing ART, dapivirine and placebo participants had similar times to virologic suppression and risks of virologic failure. These results provide reassurance that NNRTI-based ART regimens are effective among women who acquired HIV-1 while receiving the dapivirine vaginal ring. Clinical Trials Registration NCT016170096 and NCT00514098.

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