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HIV clinical trials

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NCT ID: NCT01172704 Completed - HIV Clinical Trials

HIV/AIDS, Severe Mental Illness and Homelessness

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

This is a two-arm randomized controlled trial (RCT) for 308 seriously mentally ill adults (SMI) engaging in risky sexual and/or drug use behavior, comparing a brief HIV primary and secondary prevention intervention [Skills building and Motivational Interviewing (SB-MI) to Care as Usual (CAU)]. The study setting is a large urban safety net Medical Center and outcomes will be measured at 3, 6, and 12 months. The SB-MI intervention (3 sessions + booster) was initially developed as the experimental condition in an R34 pilot project which demonstrated its feasibility and promise. For the proposed project, the investigators will recruit a larger sample which includes men and women with and without HIV, from various ethnic and racial groups, sexual orientations and housing arrangements, as well as a range of psychiatric disorders and functional capacities. In this way the investigators can more rigorously demonstrate the promise of SB-MI with SMI. The investigators will also conduct a sub-study after the 6 month follow-up to examine the impact at 12 months of an additional booster session for SB-MI participants. The investigators specific aims are: 1. To examine the effectiveness of a brief, tailored primary and secondary risk reduction strategy to CAU for people with serious mental illness. The desired outcomes include: - Decreased frequency of risk behaviors (number of partners, number of encounters) - Increased use of barrier precautions and IV needle cleaning - Positive changes in information and motivation, as well as risk behaviors - Increased HIV Counseling and Testing for those who do not know their HIV status 2. To examine the effectiveness of a 2nd booster session after the 6 month follow-up for ½ of participants randomized to SB-MI. The primary outcome will be: - Decreased frequency of risk behaviors and increased use of barrier precautions at the 12 month follow-up

NCT ID: NCT01172535 Completed - HIV Clinical Trials

A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines

Start date: November 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Treatment of children and infants with HIV requires modification of medication dosing according to a child's specific weight. For lopinavir/ritonavir (LPV/r), a second line treatment option that is increasingly necessary due to infant drug resistance, this dosing is often complicated and impractical in busy clinical settings. To address this, the World Health Organization (WHO) has released a simplified dosing table based on infant weight bands. This study will evaluate the absorption, safety, and tolerance of LPV/r in infants when dosed according to the new WHO guidelines.

NCT ID: NCT01161446 Completed - HIV Clinical Trials

Home Self-Testing for HIV to Increase HIV Testing Frequency in Men Who Have Sex With Men (The iTest Study)

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

The purpose of this study is to determine whether the availability of home self-testing for HIV will increase HIV testing frequency among men who have sex with men without negatively impacting their risk for HIV acquisition.

NCT ID: NCT01160120 Completed - HIV Clinical Trials

Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz

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

The purpose of this study is to determine the mid levels of the tenofovir, lamivudine, and efavirenz, and 144 weeks safety and efficacy of the generic fixed dose combination of tenofovir /lamivudine/efavirenz tablets 300/300/600 mg in Thai HIV-infected patients.

NCT ID: NCT01158443 Completed - Hiv Clinical Trials

Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS

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

This is an integrated medication/behavioral intervention program to increase energy, activity level and goal attainment in a sample of HIV+ adults whose presenting problems include both clinically significant fatigue and unmet vocational goals. Based on previous studies, the investigators found that many patients fail to achieve desired goals even though energy is restored by medication. To address this failure of goal attainment, the investigators will evaluate a behavioral intervention, originally based on Behavioral Activation Treatment for Depression, and modified as Behavioral Activation Program for Energy and Productivity or BA-PEP. The intervention will be conducted with patients who experience clinically significant fatigue and who want to work or receive work-related training (paid or volunteer, part time or full time) or education once energy improves with medication (armodafinil).

NCT ID: NCT01153217 Completed - HIV Clinical Trials

Multicentre Study To Assess Changes In Bone Mineral Density Of The Switch From Tenofovir To Abacavir In Hiv-1-Infected Subjects With Loss Of Bone Mineral Density

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

Most of studies have not found any consistent drug-specific association with bone loss and controversial data with respect the effect of protease inhibitors (PIs) have been published. The more evident finding with respect to this issue is the more pronounced decrease of bone mineral density (BMD) in patients during the first weeks of receiving a tenofovir (TDF)-containing regimen, probably by the effect of TDF on phosphorus balance and vitamin D metabolism.

NCT ID: NCT01148004 Completed - HIV Clinical Trials

The Influence of Ritonavir, Alone and in Combination With Lopinavir, on Fenofibric Acid Pharmacokinetics in Healthy Volunteers

Start date: May 13, 2010
Phase: Phase 1
Study type: Interventional

Background: - Patients infected with the human immunodeficiency virus (HIV) are often treated with protease inhibitors that help fight HIV infection. However, these medications often increase blood cholesterol levels, particularly triglycerides and low-density lipoproteins, and can lead to heart disease and other problems. Patients may take drugs known as fibrates (such as gemfibrozil (Lopid )) to lower triglyceride levels, but even with maximum approved doses patients often cannot reach goal triglyceride levels. Research suggests that fibrates and certain HIV medications, such as ritonavir and lopinavir/ritonavir, may interact and decrease the effectiveness of the fibrate treatment. More research is needed to determine the best drug to lower triglyceride levels in HIV patients who are receiving protease inhibitor therapy. Objectives: - To evaluate the drug-drug interaction between fenofibrate and protease inhibitors lopinavir/ritonavir and ritonavir. Eligibility: - Healthy individuals between 18 and 60 years of age. Design: - This study will require a screening visit and 18 study visits. The screening visit will take 3 to 4 hours, and can occur 7 to 30 days before starting the study. The rest of the study, not including the screening visit, is 48 days. Three of the visits will take about 12 hours, and the remaining 15 visits will take about 1 hour. - For study days 1 to 7, participants will take fenofibrate alone. Participants will keep a daily record of medication doses and any side effects. - For study days 8 to 27, participants will take fenofibrate and ritonavir. Participants will keep a daily record of medication doses and any side effects. - For study days 29 to 48, participants will take fenofibrate and lopinavir/ritonavir. Participants will keep a daily record of medication doses and any side effects. - Participants will have regular study visits to provide blood samples for research and monitoring.

NCT ID: NCT01141712 Completed - Lymphoma Clinical Trials

Autologous Transplant in HIV Patients (BMT CTN 0803)

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

This study is a Phase II, multicenter trial assessing overall survival after autologous hematopoietic stem cell transplantation using a BEAM transplant regimen (carmustine, etoposide, cytarabine, melphalan) in lymphoma patients with HIV.

NCT ID: NCT01138878 Completed - HIV Clinical Trials

HIV Testing in Non-traditional Settings Study

HINTS
Start date: July 2009
Phase: N/A
Study type: Observational

Surveillance data suggests that approximately one third of the 82 000 HIV infected adults in the UK remain undiagnosed - that is, they are living with the infection but do not know this. The majority of HIV testing in the UK to date has taken place in sexual health clinics and in antenatal care. Published National guidelines advocate routine HIV testing of 16-65 year olds in more general healthcare settings in parts of the country with relatively high rates of HIV (more than 2 per thousand individuals diagnosed locally). The HINTS Study investigates the utility, feasibility and acceptability, to patients and staff, of offering routine HIV testing in four general medical settings, all set in areas of high HIV prevalence. The settings comprise: Primary Care, Outpatients, an Acute Care Unit and an Emergency Department.

NCT ID: NCT01135082 Completed - HIV Clinical Trials

Pneumococcal Conjugate Vaccine (PCV) in HIV- Infected Children

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

The purpose of this study is to evaluate the immunogenicity and safety of 7 - valent pneumococcal conjugated vaccine in HIV - infected children, and assess the predictive factors for protective antibody responses after receiving the vaccine.