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HIV Infections clinical trials

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NCT ID: NCT01009814 Completed - HIV Infections Clinical Trials

Pharmacodynamics, Safety and Pharmacokinetics of BMS-663068, an HIV Attachment Inhibitor, in HIV-1

Start date: November 23, 2009
Phase: Phase 2
Study type: Interventional

Research Hypothesis: Administration of BMS-663068, a prodrug for HIV attachment inhibitor BMS-626529, will result in a mean decrease of at least 1 log10 in HIV RNA at Day 9 following 8 days of therapy in at least one dosing regimen that is safe and well tolerated in Clade B HIV-1 infected subjects.

NCT ID: NCT01009762 Completed - HIV INFECTIONS Clinical Trials

Immunization With HIV-1 Peptides in Adjuvant for Treatment of Patients With Chronic HIV-infection

HIV-VAC
Start date: September 2009
Phase: Phase 1
Study type: Interventional

Treatment: Immunization with a peptide-mix of 17 Clusters of Differentiation number 8 (CD8) T cell minimal epitopes and 3 Clusters of Differentiation number 4 (CD4) T cell epitopes and a new adjuvant (CAF01). The vaccine should induce cellular immunity against human immuno-deficiency virus type-1 (HIV-1). Target group: Untreated healthy individuals with chronic HIV-1 infection who are not in antiretroviral treatment. Purpose: The primary purpose is to evaluate tolerability and safety of the vaccine. The secondary purpose is to evaluate the clinical effect of the vaccination treatment as measured by induction of new T cell immunity, lowering of HIV-1 ribonucleic acid (RNA) viral load in plasma, and improvement in the patient CD4 lymphocyte blood counts. Design: The experiment is designed as a single-blinded, placebo-controlled phase 1 clinical trial in HIV-1 infected individuals in Denmark. Numbers of individuals: 20 fully evaluable HIV-1-infected patients should enter the study (15 vaccine treated and 5 placebo(saline) treated controls). The hypothesis is that a redirection of cytotoxic T lymphocyte (CTL) immunity to selected relatively immune silent (subdominant) but conserved CTL targets on multiple sites in HIV-1 could provide a better immune control of the virus replication. This could result in lowering of viral load thereby prolonging the time to antiretroviral therapy.

NCT ID: NCT01008813 Completed - HIV Infections Clinical Trials

Clinical Trial to Evaluate the Immunogenicity and Safety of an Adjuvanted A(H1N1)v Influenza Vaccine and a Non-adjuvanted A(H1N1)v Influenza Vaccine in HIV-infected Patients (ANRS 151 Hifluvac)

Start date: October 2009
Phase: Phase 2
Study type: Interventional

A 1-year multicenter, randomized, single-blinded, phase II trial, stratified on HAART. The purpose of this trial is to evaluate the immunogenicity and safety of a A(H1N1)French National Agency for Research on AIDS and Viral Hepatitis influenza vaccine, administered with or without adjuvant, in HIV-infected patients after one or two injections.

NCT ID: NCT01006031 Completed - HIV Infection Clinical Trials

Retreatment With High Doses of pegIFN Alfa-2a and Ribavirin of Previous Nonresponders HIV-coinfected Patients With Cirrhosis Due to HCV 1-4

Start date: October 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Objective: To evaluate the efficacy and safety of high doses of both peginterferon-alfa 2a (360 ug per week) plus ribavirin (800 mg b.i.d.) in HIV-infected patients with compensated liver cirrhosis by HCV genotype 1 or 4 without previous virological response(*) to a standard dose treatment of both drugs. (*) Non previous virological response: no decrease of plasma RNA-HCV at least 2 log10 after 12 weeks in treatment or breakthrough viremia while on treatment. Additionally, this study will evaluated the influence of simultaneous peginterferon-alfa 2a and ribavirin plasma concentrations on early viral response (EVR) and sustained viral response (SVR) in these patients. Method: Pilot clinical trial, phase II-III, open labeled multicenter in which patients from several hospitals of the Servicio Andaluz de Salud will be enrolled. The usual clinical and analytical follow up will be performed but additional blood samples will be obtained for determination of interferon and ribavirin plasma levels. The primary end point will be a sustained virologic response (defined as an undetectable serum HCV-RNA after 24 weeks after the cessation of treatment). Likewise, rapid virological response (at 4 weeks of treatment), early virological response (at 12 weeks), and end of treatment response rates will be evaluated as well as their relationships with the plasma interferon an ribavirin concentrations determined by ELISA and HPLC, respectively. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results. The evolution of liver fibrosis will be evaluated comparing the basal and end of treatment results of transient elastometry.

NCT ID: NCT01006005 Completed - HIV Infections Clinical Trials

Adherence-Suppression-Resistance Relationships for Atripla Compared to Historical Antiretroviral Regimens

Start date: July 2007
Phase:
Study type: Observational

The study is recruiting 50 patients initiating or switching to Atripla and comparing them to 250 individuals previously followed in a prospective study of HIV+ low income individuals recruited from homeless shelters, single room occupancy hotels and free meal food lines as part of the UCSF Reach Study. Adherence will be measured through monthly unannounced pill counts and electronic medication monitors.

NCT ID: NCT01002612 Completed - HIV Infections Clinical Trials

Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community

TACHIN003-1
Start date: December 2007
Phase: N/A
Study type: Observational

To reassess nutritional status of HIV-infected Thai children living in the family style community after receiving nutrition support program for 6 months.

NCT ID: NCT01002040 Completed - HIV Infections Clinical Trials

Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV

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

The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in HIV-infected adults. The study will enroll 150 adults (ages 20-59 years). Participants will be randomized into 2 groups and will receive either one dose or two doses of a licensed H1N1 vaccine. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 6 days.

NCT ID: NCT01001767 Completed - HIV Infections Clinical Trials

Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

Start date: April 2009
Phase: Phase 2
Study type: Interventional

Several studies have shown that there is an increased risk of heart disease in people with HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid) on improving endothelial function and decreasing inflammation which may contribute to this increased risk. The investigators will also be doing studies to analyze coagulation and inflammation markers.

NCT ID: NCT01001741 Completed - HIV Infections Clinical Trials

Pilot Study of Text Message Reminders to Improve HIV Medication Adherence in Botswana

Start date: June 2008
Phase: N/A
Study type: Interventional

While medication adherence is critical to successful treatment of HIV, there are few studies of interventions demonstrating improvements in adherence. This may be a particular challenge in the developing world, which has a larger burden of HIV but fewer resources than industrialized countries. The investigators propose a randomized controlled trial of cellular phone text message reminders to improve medication adherence. Our pilot study will be set in a large HIV clinic in Gaborone, Botswana, where Penn researchers have collaborated on research projects in the past. The primary study outcome will be antiretroviral medication adherence.

NCT ID: NCT01001507 Completed - HIV Infections Clinical Trials

Integrating Family Planning Services Into HIV Care and Treatment in Nyanza Province, Kenya

Start date: September 2009
Phase: N/A
Study type: Interventional

This is a cluster randomized trial comparing the integration of family planning services into HIV care and treatment programs versus the standard referral for family planning services outside of HIV care and treatment programs within Suba, Kisumu East, Rongo and Migori districts in Nyanza province.