Clinical Outcome of HIV-Infected Antiretroviral-Naive Patients With Discordant Immunologic and Virologic Responses to Highly Active Antiretroviral Therapy

Tan, Ruimin; Westfall, Andrew O.; Willig, James H.; Mugavero, Michael J.; Saag, Michael S.; Kaslow, Richard A.; Kempf, Mirjam Colette

doi:10.1097/qai.0b013e31816856c5

Cited by 111 publications

(105 citation statements)

References 19 publications

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“…Overall, 70% of participants in this study achieved virologic suppression in plasma (<50 copies/mL) by week 16, and 85% in CSF. Virologic suppression rates in this trial were less than in most clinical trials, but similar to those in community practice (eg, [16]). There are several potential explanations for this.…”

Section: Characteristics Of Arv Regimens and Treatment Responsesmentioning

confidence: 92%

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Randomized Trial of Central Nervous System–Targeted Antiretrovirals for HIV-Associated Neurocognitive Disorder

Ellis¹,

Letendre

Vaida

et al. 2013

Clinical Infectious Diseases

117

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Background. Antiretroviral (ARV) medications differentially penetrate across the blood-brain barrier into central nervous system (CNS) tissues, potentially influencing their effectiveness in treating brain infection.Methods. This randomized controlled clinical trial (RCT) called for 120 participants at 5 study sites to be randomized 1:1 to CNS-targeted (CNS-T) or non-CNS-T ART. Entry clinical factors such as ARV experience were balanced across arms using an adaptive randomization approach. The primary outcome, change in neurocognitive performance, was measured as the difference in global deficit score (GDS) from baseline to week 16.Results. The study was terminated early on the recommendation of its data safety monitoring board on the basis of slow accrual and a low likelihood of detecting a difference in the primary outcome. No safety concerns were identified. Of 326 participants screened, 59 met entry criteria and were randomized. The primary intentto-treat analysis included 49 participants who completed week 16. These comprised 39 men and 10 women with a mean age of 44 years (SD, 10 years), and median nadir and current CD4 + T-cell counts of 175 cells/µL and 242 cells/µL, respectively. The proportional improvement in GDS from baseline was nonsignificantly larger (7%; 95% confidence interval [CI], −31% to 62%) in the CNS-T arm than in the non-CNS-T arm, representing a treatment effect size of 0.09 (95% CI, −.48 to .65). Prespecified secondary analysis showed a trend interaction (P = .087), indicating that participants who had baseline plasma virologic suppression may have benefited from CNS-T.Conclusions. This study found no evidence of neurocognitive benefit for a CNS-T strategy in HIV-associated neurocognitive disorders. A benefit for a subgroup or small overall benefits could not be excluded.Clinical Trials Registration. NCT00624195.

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Section: Characteristics Of Arv Regimens and Treatment Responsesmentioning

confidence: 92%

“…Within the virologically suppressed subset, those randomized to CNS-T (n = 7) had a mean GDS improvement (−0.27 [95% CI, −.56 to .02]), whereas those randomized to non-CNS-T (n = 6) worsened (0. 16 . The subgroups did not differ by sex, prior nadir CD4 + count, HCV confection, or initial GDS.…”

Section: Prespecified Secondary Analysesmentioning

confidence: 99%

Randomized Trial of Central Nervous System–Targeted Antiretrovirals for HIV-Associated Neurocognitive Disorder

Ellis¹,

Letendre

Vaida

et al. 2013

Clinical Infectious Diseases

117

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“…Box 251 1480, Jimma, ETHIOPIA Tel: +251 911 68 0576 patients (14,15), with good outcomes overall (16,17). Results from observational studies suggest that at least 73.5% of patients initiating HAART achieve complete virological suppression within 6 months (18), but 9%-45% of patients do not experience an appropriate increase in their CD4 cell counts in the short term (19,20). While an increase in total CD4+ T lymphocytes is readily detectable, the ability to regenerate immunocompetent T-cell populations remains unresolved (21).…”

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confidence: 99%

Immunological and clinical progress of HIV-infected patients on highly active antiretroviral therapy in north west Ethiopia

Wabe¹,

Alemu²

2012

Gaziantep Med J

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The survival benefits of highly active antiretroviral therapy (HAART) in HIV infected patients have been studied well in the developed world. In resource poor settings like Ethiopia such treatment was started only in 2003. As a result, the existing treatment guidelines and recommendations are based on data from the developed world. The objective of this study was to determine the immunological and clinical progress in HIV/AIDS patients in one year data review of patients' card who initiated on HAART in Ethiopia. A retrospective cohort study was done based on past medical records of HIV/AIDS patients, using a structured data collection format. All patient cards of one year data with patients who initiated HAART from October 1, 2006 to November 30, 2007 were included in the study. The data collected was analyzed using SPSS for window version 16.0. The majority of the study population (383, 64.2%) were prescribed zidovudine/lamivudine/neverapine (ZDV/3TC/NVP) regimen initially. Overall functional status change showed that ability to work was increased by 31.5%, being ambulatory decreased by 93.4% and bedridden status decreased by 80%. A total of 240 (46.9%) patients have showed functional status improvement. Average mean weight change of 5.9 kg (increment by 11.9%) was seen during a one year follow-up. The patients showed immunological change from 132.883 mean CD4/mm 3 count to 335.87 mean CD4/mm 3 . About 492 (82.4%) patients present with different type of opportunistic infections (OIs) at start of therapy which dramatically dropped to only 40 (6.7%) patient after one year of receiving HAART. HAART initiation has decreased progression of the diseases and improved the patients' quality of life. Most patients have showed a significant increment in their CD4 count. The restoration of CD4 in turn has improved the clinical status of most patients. Despite the significant progression of health of patients, greater immunological and clinical success should be attained by encouraging patients for effective use of those lifesaving drugs with maximal adherence. 2) başlangıçta zidovudin/lamivudin/neverapin (ZDV/3TC/NVP) tedavisi verilmişti. Genelde fonksiyonel durum değişimi, çalışma yeteneğinin %31.5 arttığını, ayakta tedavi edilmenin %93.4 azaldığını, yatağa bağlı kalma durumunun %80 azaldığını gösterdi. Toplam 240 hasta fonksiyonel durum düzelmesi gösterdi. Bir yıllık izleme sırasında 5.9 kg ortalama ağırlık değişimi (%11.9 artma) gözlendi. Hastalar ortalama 132.883 CD4/mm 3 sayımından ortalama 335.87 CD4/mm 3 'e immünolojik değişim gösterdi. Tedavinin başlamasında farklı tipte fırsatçı enfeksiyonu bulunan yaklaşık 492 (%82.4) hasta, HAART tedavisi başlamasından bir yıl sonra dramatik olarak sadece 40'a (%6.7) düştü. HAART tedavisi başlanması hastalığın ilerlemesini azalttı ve hastaların yaşam kalitesini iyileştirdi. Hastaların çoğu CD4 sayılarında anlamlı artışlar gösterdi. CD4'deki düzelme birçok hastanın klinik durumunu iyileştirdi. Hastaların sağlığındaki anlamlı iyileşmeye karşın, hayat kurtaran bu ilaçlara d...

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“…La proclividad a reinfecciones podría haber sido condicionada por el particular estado de respuesta inmune de este paciente (CD4 -/ VL + : respuesta virológica exclusiva), expresada en respuestas discordantes al Targa (29) . Los cultivos reportados, los hallazgos clínicos sistémicos, la excelente respuesta al tratamiento anti-MDR-TB y las características de las lesiones osteolíti-cas respaldan el diagnóstico de una TBC sistémica, incluida la ósea, en coinfección con VIH (30) .…”

Section: Discussionunclassified

Paciente VIH positivo con tuberculosis sistémica y lesiones osteolíticas de la calvaria, semejando mieloma múltiple

et al. 2011

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This is the case of a 33 years old man with history of homosexual relations and heavy alcohol drinking. Tobacco, marijuana, cocaine, basic paste and cocaine hydrochloride consumption since age 18. Because of human immunodeficiency virus infection he received irregular treatment (2006)(2007)(2008) with highly active antiretroviral therapy (HAAT), regulated in the past 12 months. As the patient showed positive resistant acid-fast bacilli he received since June 2008 standard antituberculous treatment [2RHZE/4(HR)2)] (R: rifampicin; H: isoniazid; Z: pirazinamide; E: ethambutol) that was withdrawn 6 months later when the patient showed pulmonary negative acid fast bacilli. In March 2009 he felt intense lumbar pain, difficulty in walking, hypertrophy of cervical lymph nodes, cough and fever. Cervical lymph node discharge culture disclosed M. tuberculosis resistant to rifampicin. Imagenology showed several lytic lesions in skull and thoraco-lumbar vertebrae; also renitent swellings in scalp, right forearm and left rib cage. After multiple myeloma and metastatic cancer were excluded, the patient received multidrug resistant tuberculosis treatment added to HAAT, showing two months later involution of renitent swellings, absence of fever and overall improvement. After 16 months of supervised treatment, the patient gained 7 kg and all symptomatology previously present dissappeared. We discuss the pathophysiology of craniovertebral osteolytic lesions in a patient with coinfection of human immunodeficiency virus and tuberculosis.

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Clinical Outcome of HIV-Infected Antiretroviral-Naive Patients With Discordant Immunologic and Virologic Responses to Highly Active Antiretroviral Therapy

Abstract: Discordant immunologic and virologic responses at 3 to 9 months after HAART initiation play important roles in predicting long-term clinical outcomes in treatment-naive patients.

Cited by 111 publications

References 19 publications

Randomized Trial of Central Nervous System–Targeted Antiretrovirals for HIV-Associated Neurocognitive Disorder

Randomized Trial of Central Nervous System–Targeted Antiretrovirals for HIV-Associated Neurocognitive Disorder

Immunological and clinical progress of HIV-infected patients on highly active antiretroviral therapy in north west Ethiopia

Paciente VIH positivo con tuberculosis sistémica y lesiones osteolíticas de la calvaria, semejando mieloma múltiple

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