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NCT ID: NCT01101815 Completed - HIV Infections Clinical Trials

Adherence to HIV Therapy in Heroin Addicts: Oral vs XR-NTX

Start date: June 2010
Phase: Phase 2
Study type: Interventional

Substance use, particularly the compulsive behaviors associated with addiction, lead to unhealthy behaviors including non-adherence to antiretroviral therapy (ART) and treatment failure. High on the list of disorders leading to non-adherence is heroin addiction as a wide range of impulsive, high-risk behaviors accompanies it. The science of adherence would be improved by developing new methods to prevent relapse to heroin addiction, especially methods that can be used in settings that are not limited by the aims to test such a method using an implantable naltrexone formulation (IN) that is approved in Russia and blocks opioid effects for 3 months. The efficacy of the IN should be better than oral naltrexone (ON) because it does not depend on daily behavior to take a tablet and maintains a constant plasma level for months, which should result in sustained blockade, less relapse, and better ART adherence and treatment response.

NCT ID: NCT01095796 Completed - HIV Infections Clinical Trials

Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Start date: March 2010
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor-based STRs.

NCT ID: NCT01093417 Completed - HIV Infections Clinical Trials

Study of Vitamin D and Effect on Heart Disease and Insulin Resistance

Start date: January 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and PTH.

NCT ID: NCT01089114 Completed - HIV Clinical Trials

Cardiovascular Radiologic and Metabolic Assessment in HIV: An Investigation of Pathophysiology

Start date: March 8, 2010
Phase: N/A
Study type: Observational

Background: - Antiretroviral therapy has increased the lifespan of people with human immunodeficiency virus (HIV), but recent research suggests that people with HIV also have an increased risk of developing cardiovascular disease. To better understand the prevalence and effects of heart disease in people with HIV, researchers are interested in comparing heart imaging and metabolism studies to see if there are differences between HIV-positive and HIV-negative people. Objectives: - To study metabolism and heart function in people with HIV compared with healthy HIV-negative volunteers. Eligibility: - Individuals at least 18 years of age who either have been diagnosed with HIV or are healthy HIV-negative volunteers. Design: - Participants will be evaluated with a physical exam, detailed medical history, and routine blood and urine tests including HIV testing. - Participants will have the following imaging scans: - Cardiac magnetic resonance imaging (MRI) to study the health of the heart and blood vessels - Magnetic resonance spectroscopy (MRS) of the heart, liver, and skeletal muscle - Cardiac computerized tomography (CT) scan to measure calcium levels in the heart and nearby arteries - Dual-energy x-ray absorptiometry (DEXA) scan to measure body fat and muscle mass. - Stable isotope infusion to evaluate how the body processes fat (which will require an overnight stay before the test) - Participants will also have blood tests, an echocardiogram, and an electrocardiogram to evaluate heart function.

NCT ID: NCT01088516 Completed - HIV Clinical Trials

Clinical Study of an Aluvia-based HAART Regimen for Prevention of Mother-to-child HIV Transmission in Africa

Start date: December 2008
Phase: Phase 4
Study type: Interventional

Therapeutic options to prevent vertical transmission of HIV remain limited. Combination antiretroviral therapy in the form of HAART (Highly Active Anti Retroviral Therapy) is generally recommended in the developed world, both for its ability to reduce maternal viral load, and thus the likelihood of transmission, as well as for its prevention of drug resistance mutations, which might otherwise reduce future options for therapy in the mother, infant, or both. Exclusive formula-feeding is also recommended in the developed world (where clean water sources & adequate hygiene is reliably available) to prevent HIV transmission through breastmilk, however, this is not yet a feasible option in many developing world settings due to economic, infrastructure, social and infant-health reasons. The investigators propose use of a HAART regimen during pregnancy and breastfeeding that is based upon the recently released Aluvia tablets (tablet form of LOPINAVIR/RITONAVIR or LOP; established capsule form is known as Kaletra) to improve maternal virological control and thus mother-to-child-transmission (MTCT). Hypothesis: Maternal use of HAART containing Zidovudine, 3TC and Aluvia (Lopinavir/Ritonavir) can prevent antepartum, and intrapartum transmission of HIV, as well as allow exclusive and then subsequent complementary feeding to be carried out with minimum risk to the mother and infant. - Study regimen: ZDV/3TC (combivir) + 2 Aluvia Tabs all PO BID to start at 14-30 weeks gestational age (GA) and continue through labor and as long as the mother breastfeeds - Peripartum single dose Nevirapine (sdNVP) (Note: Mothers will also be receiving ZDV as part of the study regimen) to mother and sdNVP + 5 days postpartum ZDV to the infant will be given as per current Zambian practice - Exclusive breastfeeding (EBF) x 6 months then complementary foods to be added, with aim for a gradual wean of breastfeeding by infant age of 12-13 months. In case of inability to wean by 13 months, however, drug will be continued until the mother has achieved a complete wean. - Follow-up period: Mother & child will be followed to an infant age of 24 months, as per schedule-of-visits (approx every 3 months) Major outcome measure: infant survival and negative dbs (dried blood spot) PCR 3 months post weaning.

NCT ID: NCT01087814 Completed - HIV Infections Clinical Trials

Sustiva Levels With Use of a Gel Capsule

Start date: February 2010
Phase: Phase 4
Study type: Interventional

We are studying if putting a gel capsule over a standard HIV drug changes the ability of the body to absorb the drug. This is important because we want to be able to study new HIV drugs against the most common drugs used today and the most common is Sustiva, which is also called efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how much is absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days and we will draw blood to see how much is absorbed.

NCT ID: NCT01084954 Completed - HIV Infections Clinical Trials

Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection

Start date: March 2009
Phase: N/A
Study type: Observational

Validate a simple and cost-effective Nucleic Acid Test for HIV Detection in order to develop a rapid, highly sensitive and specific, one-stage test for the diagnosis of HIV infection. Blood samples collected will be assayed using the BioHelix Corporation helicase-dependent amplification or the Cepheid Xpert HIV-1 Quant Assay. A false negative or false positive rate of >1.0% would make this test unacceptable as a screening test for HIV viremia.

NCT ID: NCT01084382 Completed - HIV Clinical Trials

" Arthrospira Platensis" as Nutrition Supplementation for Female Adult Patients Infected by HIV in Yaoundé Cameroon

Start date: April 2010
Phase: N/A
Study type: Interventional

Early interests in Arthrospira p. (Spirulina) were based on its high source of protein. Recently, it has drawn attention for its therapeutic effects including anticancer properties, antiviral and antibacterial properties as well as improvement of the immune system. The aim of this study is to investigate the effect of a daily supplementation with Spirulina for adult wife living with HIV/AIDS in Yaoundé.

NCT ID: NCT01073761 Completed - HIV Infections Clinical Trials

Atazanavir/Ritonavir and Darunavir/Ritonavir PK Tail Study

Start date: April 2010
Phase: Phase 1
Study type: Interventional

The purpose of the study is to look at the levels of three HIV medications darunavir, ritonavir and atazanavir in the blood after the drug intake has been stopped in order to understand how long these drugs persist in blood for. The study will specifically look at these three drugs blood levels after taking them for 10 days everyday. The main objective is to provide information on the potential safety (in terms of preventing virological failure and the development of resistance)of delaying drug doses occasionally by providing information on the decline in drug concentration after dosing has stopped.

NCT ID: NCT01070017 Completed - HIV Infections Clinical Trials

Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

CASA
Start date: February 2010
Phase: Phase 3
Study type: Interventional

Using quantitative and qualitative data, this study will assess the impact of community accompaniment with supervised antiretrovirals (CASA) on HIV-positive individuals and community members in Lima, Peru.