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NCT ID: NCT01710397 Completed - HIV Clinical Trials

Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa (RapIT Study)

RapIT
Start date: May 2013
Phase: N/A
Study type: Interventional

One of the most serious challenges facing antiretroviral therapy (ART) programs for HIV/AIDS in resource-constrained settings is the failure of ART-eligible patients to complete the steps required to initiate treatment. The high rate of loss to care of patients who are treatment-eligible at HIV diagnosis may be due in part to the large number of steps required between receiving an HIV diagnosis and obtaining the first dose of antiretrovirals (ARVs). In South Africa, these steps usually require approximately four clinic visits over a period of 2-8 weeks before a patient can start treatment. One strategy proposed for reducing losses among those eligible for ART is to simplify and condense the steps required for starting treatment. This is now possible because new, point-of-care (POC) tests for CD4 counts and tuberculosis (TB) diagnosis are available. These technologies can be combined with changes to clinic schedules to allow all steps required for ART initiation under South African guidelines (lab tests, physical exam, education) to take place on the day the patient presents for an HIV test. This study is a randomized strategy evaluation of the feasibility, effectiveness, and cost-effectiveness of rapid ART initiation. Outpatient, non-pregnant, HIV-positive adults who come to a South African clinic for an HIV test, consent to study participation, and are eligible for ART will be randomized 1:1 to rapid ART initiation or to standard care. Those who are assigned to rapid ART initiation will have the possibility of receiving their first dose of ARVs as early as the same day, while those who are assigned to standard care will follow the clinic's usual procedures for starting ART. Rapid ART initiation for HIV-positive pregnant women, which has recently become the standard of care in South Africa, will also be assessed in a programmatic evaluation conducted alongside the randomized evaluation, with a retrospective comparison group. The primary study outcome for non-pregnant adults will be remaining alive, in care and virally suppressed 10 months after having a positive HIV test at the study site or making a first HIV-related visit. The primary study outcome for pregnant women will be adherence to ART until delivery. The cost effectiveness of the rapid initiation strategy will be assessed as the cost per patient achieving the primary outcome for each population.

NCT ID: NCT01707472 Completed - HIV Clinical Trials

Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis

Start date: October 4, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to assess the safety and tolerability of simtuzumab (formerly GS-6624) in HIV and/or hepatitis C virus (HCV)-infected adults with evidence of liver fibrosis.

NCT ID: NCT01705041 Completed - HIV Clinical Trials

Preliminary Evaluation of a Point-Of-Care Liver Function Test

DFA
Start date: June 2012
Phase: N/A
Study type: Interventional

The proposed preliminary field evaluation will compare a point-of-care (POC) transaminase test with the standard of care test used in an HIV clinic at the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam.

NCT ID: NCT01701882 Completed - HIV Clinical Trials

A Pilot Study to Assess the Feasibility of Switching, Individuals Receiving Atripla With Continuing Central Nervous System (CNS) Toxicity, to a Fixed Dose Combination of Tenofovir/Emtricitabine/Rilpivirine

Start date: September 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to investigate the benefits of switching away from efavirenz (which patients are taking in combination with Kivexa® or as part of the combination pill, Atripla®) in patients with central nervous system side effects (such as insomnia {difficulty with sleeping}, bad dreams etc). The investigators in this study will investigate the effect of switching to a single tablet regimen (Eviplera®) containing tenofovir, emtricitabine and rilpivirine. If patients are currently taking Atripla, rilpivirine will be the only new component of the combination. Rilpivirine is a drug for HIV treatment, licensed for first-line treatment. In combination with Truvada®, it showed fewer side effects when compared to efavirenz in 2 other clinical studies, where patients were starting HIV treatment for the first time. This study will also investigate the safety (in terms of other side effects and the routine blood tests which we ordinarily use to monitor your treatment) and monitor effectiveness, your viral load and CD4 counts, when you switch treatment to tenofovir/emtricitabine/rilpivirine.

NCT ID: NCT01701635 Completed - HIV Clinical Trials

SANKOFA Pediatric HIV Disclosure Intervention

Start date: January 2013
Phase: N/A
Study type: Interventional

A culturally-relevant, theoretically and empirically sound, patient-centered, standardized disclosure intervention that can be integrated into routine clinical pediatric HIV care has potential to prevent transmission and improve the welfare of children and their caregivers in Ghana and other resource-limited settings. Results from this project will also further an understanding of factors and processes driving pediatric HIV disclosure.The study hypothesis is that several key barriers to disclosure of HIV status can be modified and the process of disclosure promoted with an intervention approach that is grounded in a traditional Ghanaian concept.

NCT ID: NCT01701206 Completed - HIV Clinical Trials

HOPE (Harnessing Online Peer Education): Using Online Social Networks for HIV Prevention and Testing

HOPE
Start date: July 2009
Phase: N/A
Study type: Interventional

This study seeks to determine whether social networking technologies can be used to increase HIV prevention and testing.The HOPE (Harnessing Online Peer Education) model seeks to apply a diffusion of innovations style intervention to social media to increase HIV testing.

NCT ID: NCT01699841 Completed - HIV Clinical Trials

Breast Milk Composition and HIV-exposed/Unexposed Early Infant Growth and Infectious Disease Events

Start date: April 2012
Phase: N/A
Study type: Observational

The purpose of this study is to understand how breast milk may protect infants from infection and promote favorable immunological, growth and development outcomes. By following mothers and their infants, we will evaluate the important interactions between infant immune responses and infectious disease events in relation to breast milk composition and feeding patterns. Our aim is to identify a set of predictive factors corresponding to healthy early infant growth and development in this setting in Northern Tanzania.

NCT ID: NCT01697540 Completed - HIV Clinical Trials

Management of Highly Active Anti-retroviral Therapy-related Hyperlipidemia Among HIV-infected Patients in Taiwan

Start date: September 2012
Phase:
Study type: Observational

1. Written informed consent must be obtained before any study specific procedures are undertaken. 2. The process of the experiment (brief describe) The patients must come back for follow during 4 to 12 weeks after starting the new therapy. The investigators will follow the patients' lipid profile and any side effects and stop the observation till 36 months after starting the new therapy. The serum level of HIV-VL, CD4, GOT, GPT, triglyceride, cholesterol, HDL-cholesterol, and LDL-cholesterol will be checked every 3 months. The patients' chart and all data will be delinked to protect the patients' right and privacy.

NCT ID: NCT01697007 Completed - HIV Clinical Trials

A Phase II Trial to Assess the Safety and Immunogenicity of DNA Priming Administered by the ID Zetajet® With or Without ID Derma Vax™ Electroporation Followed by IM MVA Boosting in Healthy Volunteers in Tanzania and Mozambique

TaMoVac II
Start date: November 2012
Phase: Phase 2
Study type: Interventional

Electroporation will increase the efficiency of DNA priming in terms of immune responses and will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine concentration will reduce the number of shots necessary to deliver the full dose and induce comparable immune responses as with lower DNA vaccine concentrations.

NCT ID: NCT01695954 Completed - HIV Clinical Trials

Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz

Start date: May 2012
Phase: Phase 1
Study type: Interventional

The main goal of this study is to determine how taking efavirenz affects the levels of pitavastatin in the bloodstream when both drugs are taken together and to see how darunavir with ritonavir affects the levels of pitavastatin in the bloodstream. Secondary goals are to see how taking pitavastatin affects the levels in the blood of efavirenz when both drugs are taken together and to see how taking pitavastatin affects the levels in the blood of darunavir.