A Phase I Double-Blind Study to Evaluate the Safety and Immunogenicity of HIV Prime/Boost Vaccine Using DNA and MVA for HIV-1/AIDS
This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of DNA and modified vaccinia virus Ankara (MVA) HIV-1 vaccines in subjects receiving stable highly active antiretroviral therapy (HAART) who have an HIV-1 RNA < 50 copies/mm3 and CD4+ T cells count ≥ 350 cells/mm3.
NCT01881581 — Acquired Immunodeficiency Syndrome
Status: Recruiting
http://inclinicaltrials.com/acquired-immunodeficiency-syndrome/NCT01881581/
The Living Well Project: Early Palliative Care and Motivational Interviewing (MI) for Persons With AIDS
The overall goal of this project is to implement and test the efficacy of an enhanced comprehensive multidisciplinary early palliative care (EPC) package that includes four motivational interviewing sessions (MI) for persons diagnosed with AIDS. We posit that the innovative EPC will improve quality of life, clinical and psychosocial outcomes and advance care planning in a cost effective manner and could promote engagement and retention in HIV care. If successful, it could serve as a model of early palliative care for persons with AIDS in the US.
NCT01848483 — Acquired Immunodeficiency Syndrome (AIDS)
Status: Completed
http://inclinicaltrials.com/acquired-immunodeficiency-syndrome-aids/NCT01848483/
Impact of a Dolutegravir-based Regimen on Early Mortality of Severely Immunocompromised AIDS Patients
The current available antiretroviral (ARV) agents make possible a successful treatment of virtually all HIV-infected patients, but some problems related to early mortality are still of concern, mainly in resources-limited settings. There are several published reports showing that such patients are at a significantly higher risk of death during the first months of treatment, in comparison with the observed outcomes in developed countries. One of the consistently detected risks for early mortality across these reports is the baseline low CD4 count, although it does not seem to be the only reason for such outcome. In Brazil and other developing countries, there is still a large proportion of AIDS patients who are diagnosed with AIDS, or only seek health care for HIV infection late in the course of disease. Dolutegravir (DTG), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The available evidence suggest it promotes a faster decline in HIV-1 plasma viremia, and a higher increase in CD4 cells count, in comparison with those in Efavirenz (EFV) arm. The investigators propose to compare the impact of DTG versus EFV in the early mortality rates for severely ill (CD4+ cells count <50 cells/mm3) patients starting ARV therapy.
NCT01837277 — Severely Immunocompromised HIV Patients
Status: Completed
http://inclinicaltrials.com/severely-immunocompromised-hiv-patients/NCT01837277/
Auditory Rehabilitation From the Perspective of the Significant Other
The purpose of this study is to examine the effect of enhanced patient-centered counseling (PCC) and the influence of spousal involvement in pre-fitting counseling on hearing-aid outcomes.
NCT01809496 — Hearing Loss
Status: Terminated
http://inclinicaltrials.com/hearing-loss/NCT01809496/
A Phase 1 Double Blind Placebo-controlled Clinical Trial to Evaluate the Safety and to Compare the Priming Ability of NYVAC Alone Versus NYVAC + AIDSVAX® B/E, and DNA Alone Versus DNA + AIDSVAX® B/E When Followed by NYVAC + AIDSVAX® B/E Boosts in Healthy, HIV-1-uninfected Adult Participants
This study will evaluate the safety of and the body's immune response to experimental HIV vaccine regimens using different vaccine priming combination, and boosting with the vaccines NYVAC and AIDSVAX® B/E.
NCT01799954 — HIV Infections
Status: Completed
http://inclinicaltrials.com/hiv-infections/NCT01799954/
Randomized Controlled Trial of Situated Optimal Adherence Intervention Estonia (sOAI Estonia) Among Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia
The specific aim of the study is to assess antiretroviral therapy adherence and evaluate the impact of a situated treatment adherence intervention program among persons living with HIV/AIDS on antiretroviral therapy in Estonia.
NCT01789138 — HIV
Status: Completed
http://inclinicaltrials.com/hiv/NCT01789138/
Palliative Care in People Living With HIV/AIDS: Integrating Into Standard of Care
Our goal is to advance palliative care with persons living with AIDS (PLWA) or life-limiting co-morbidities to decrease suffering and increase quality of life (QOL). Left without advance care planning (ACP) for end-of-life decision, miscommunication and disagreements may result in families being charged with neglect or court battles over treatment choices, unmet care or delivery of unnecessary or unwanted care, and non-relative caregivers being dismissed (e.g. gay partners). We hope to increase families' understandings of their family member's wishes for end-of-life care to decrease conflict through the FAmily-CEntered Advance (FACE) Care Planning intervention. We will also study communication, quality of life, and spiritual struggle. Families will be randomized into either the Control (N=96 families) or the FACE Intervention (n=192 dyads). FACE families will meet with a trained/certified researcher for two 60-minute sessions scheduled one week apart: Session 1: The Respecting Choices Interview®; and Session 2: Completion of The Five Wishes©. Control families will also meet with a researcher for two 60-minute sessions scheduled one week apart: Session 1: Developmental History; and Session 2: Nutrition and Exercise. Questionnaires will be administered five times, Baseline and at 3, 6, 12 and 18 month post-intervention, for an average of 2 years. AIM 1. To determine the efficacy of FACE on congruence in treatment preferences between PLWA and their surrogates over time, and the effect of the pattern of congruence development trajectory on healthcare utilization (i.e., distal outcomes: number of hospitalizations, dialysis, ER visits). Hypothesis A: Development of congruence may not be homogeneous and FACE may influence the pattern of congruence development. Hypothesis B: Different patterns of congruence development may have different effects on health care utilization. Hypothesis C: Compared to Controls, FACE participants will better maintain congruence over time. AIM 2. To determine the efficacy of FACE on key components of QOL for PLWA. Hypothesis: FACE participants will increase or better maintain psychosocial QOL compared to Controls. AIM 3. To minimize health disparities in ACP between Blacks and non Blacks and identify factors associated with disparities. Hypothesis: Blacks in the FACE intervention will complete advance directives at a rate comparable to non Blacks, and at significantly greater rates compared to Controls.
NCT01775436 — HIV
Status: Completed
http://inclinicaltrials.com/hiv/NCT01775436/
Phase I/II Study of Oral MEK Inhibitor Selumetinib (AZD6244 Hyd-Sulphate) in Combination With Highly Active Anti-Retroviral Therapy (HAART) in AIDS-associated Kaposi's Sarcoma (KS).
Cancer is a leading cause of death in individuals living with human immunodeficiency virus (HIV), and Kaposi's sarcoma (KS) remains the commonest HIV-associated cancer. KS is caused when individuals become infected with both HIV and another virus, Human herpesvirus-8 (HHV-8). Laboratory studies have shown that HHV-8 can stimulate biological pathways within KS lesions which promotes their growth. Selumetinib targets these pathways and may therefore be a useful new therapy for KS. Phase I of this trial aims to identify the best dose for the use of selumetinib and investigate the effects of selumetinib treatment on the anti-viral treatment HIV patients receive to control HIV infection. Phase II of this trial will investigate how well selumetinib works as a treatment for KS at the best dose determined in phase I.
NCT01752569 — AIDS-related Kaposi's Sarcoma
Status: Terminated
http://inclinicaltrials.com/aids-related-kaposi-s-sarcoma/NCT01752569/
Assessment of Cognitive Functioning as it Relates to Risk for Suicide in Veterans With HIV/AIDS
The purpose of this project is to gather pilot data related to exploring relationships between cognitive impairment and/or psychiatric distress and suicidal thoughts and/or behaviors in Veterans with Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS). To achieve this goal, a neuropsychological battery will be administered to Veterans with HIV/AIDS.
NCT01749007 — HIV/AIDS
Status: Completed
http://inclinicaltrials.com/hiv-aids/NCT01749007/
Veterans Living With HIV/AIDS: A Pilot Study Examining Risk Factors Associated With Self-Directed Violence
The purpose of this project is to gather pilot data related to risk factors associated with suicide in Veterans with Human Immunodeficiency Virus (HIV)/ Acquired Immune Deficiency Syndrome (AIDS) and to develop an educational and interventional tool and instructional guide that can be utilized by local and national providers to increase understanding regarding suicide risk assessment. There are no hypotheses associated with this qualitative pilot study.
NCT01748968 — Self-Directed Violence
Status: Completed
http://inclinicaltrials.com/self-directed-violence/NCT01748968/