Dataset Information

A Pilot Study of Raltegravir Plus Combination Antiretroviral Therapy in Early Human Immunodeficiency Virus Infection: Challenges and Lessons Learned.

ABSTRACT: Availability of integrase strand transfer inhibitors created interest in determining whether their use would decrease persistently infected cell numbers. This study hypothesized that adding raltegravir (RAL) to standard antiretroviral therapy (ART) would decrease human immunodeficiency virus (HIV)-infected CD4(+) T cells more than standard combination ART. This was a pilot, randomized study comparing open-label standard triple ART to standard triple ART plus RAL over 96 weeks in ART-naive adults with early HIV infection. The primary objective was to compare quantity and trajectory of HIV DNA. Eighty-two persons were referred. A diverse set of reasons precluded the enrollment of all but 10. Those who enrolled and completed the study had an estimated median duration of HIV infection of 74 days at ART start. The groups had similar baseline characteristics. The RAL group had more rapid first phase plasma HIV RNA decay (0.67?log10 copies/mL/day) than with combination ART (0.34?log10copies/mL/day), p?=?0.037. Second phase HIV RNA decay, residual viremia, cell-associated RNA, HIV DNA, CD4(+) T-cells with replication-competent virus, and 2LTR circle levels did not differ between groups. Among those with entry plasma HIV RNA levels above the median, 2LTR circles were significantly lower over time than in those with lower entry HIV RNA levels (p?=?0.02). Our results suggest homogeneity of responses in cell-associated RNA, HIV DNA, CD4(+) T-cells with replication-competent virus, and 2LTR circles with early HIV in both ART groups. The kinetics of 2LTR DNA did not reflect the kinetics of plasma HIV RNA decline following ART initiation.

SUBMITTER: Collier AC

PROVIDER: S-EPMC4744890 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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A Pilot Study of Raltegravir Plus Combination Antiretroviral Therapy in Early Human Immunodeficiency Virus Infection: Challenges and Lessons Learned.

Collier Ann C AC Chun Tae-Wook TW Maenza Janine J Coombs Robert W RW Tapia Kenneth K Chang Ming M Stevens Claire E CE Justement J Shawn JS Murray Danielle D Stekler Joanne D JD Mullins James I JI Holte Sarah E SE

BioResearch open access 20160101 1

Availability of integrase strand transfer inhibitors created interest in determining whether their use would decrease persistently infected cell numbers. This study hypothesized that adding raltegravir (RAL) to standard antiretroviral therapy (ART) would decrease human immunodeficiency virus (HIV)-infected CD4(+) T cells more than standard combination ART. This was a pilot, randomized study comparing open-label standard triple ART to standard triple ART plus RAL over 96 weeks in ART-naive adults ...[more]

PMID: 26862469

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Project description:BACKGROUND:Patients with advanced pancreatic cancer suffer from high morbidity and mortality. Specialty palliative care may improve quality of life. OBJECTIVE:Assess the feasibility, acceptability, and perceived effectiveness of early specialty physician-led palliative care for patients with advanced pancreatic cancer and their caregivers. DESIGN:A mixed-methods pilot randomized controlled trial in which patient-caregiver pairs were randomized (2:1) to receive specialty palliative care, in addition to standard oncology care versus standard oncology care alone. SETTING/SUBJECTS:At a National Cancer Institute-designated comprehensive cancer center in Western Pennsylvania, 30 patients with advanced pancreatic adenocarcinoma and their caregivers (N?=?30), oncologists (N?=?4), and palliative care physicians (N?=?3) participated. MEASUREMENTS:Feasibility (enrollment, three-month outcome-assessment, and intervention completion rates), acceptability, and perceived effectiveness (process interviews with patients, caregivers, and physicians). RESULTS:Consent:approach rate was 49%, randomized:consent rate 55%, and three-month outcome assessment rate 75%. Two patients and three caregivers withdrew early. The three-month mortality rate was 13%. Patients attended a mean of 1.3 (standard deviation 1.1) palliative care visits during the three-month period. Positive experiences with palliative care included receiving emotional support and symptom management. Negative experiences included inconvenience, long travel times, spending too much time at the cancer center, and no perceived palliative care needs. Physicians suggested embedding palliative care within oncology clinics, tailoring services to patient needs, and facilitating face-to-face communication between oncologists and palliative physicians. CONCLUSIONS:A randomized trial of early palliative care for advanced pancreatic cancer did not achieve feasibility goals. Integrating palliative care within oncology clinics may increase acceptability and perceived effectiveness.

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Dataset Information

A Pilot Study of Raltegravir Plus Combination Antiretroviral Therapy in Early Human Immunodeficiency Virus Infection: Challenges and Lessons Learned.

Publications

A Pilot Study of Raltegravir Plus Combination Antiretroviral Therapy in Early Human Immunodeficiency Virus Infection: Challenges and Lessons Learned.

Similar Datasets

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