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NCT ID: NCT00270465 Completed - HIV Clinical Trials

Safety and Immune Response to a Prime-Boost Vaccination Schedule in HIV-infected Patients

Start date: December 21, 2005
Phase: Phase 1
Study type: Interventional

Study Design: This is a Phase I, randomized, placebo-controlled, double-blinded study to examine safety, tolerability and immune response of a prime-boost vaccination regimen for treatment of HIV infection. The vaccination schedule consists of three injections of a multiclade HIV plasmid DNA vaccine followed by one injection of a multiclade recombinant adenoviral vector vaccine (rAd), in HIV-infected adults. The hypothesis is that this vaccination regimen will be safe and elicit an immune response in HIV-infected subjects. The primary objectives are related to evaluating the safety and tolerability of the vaccination regimen and assessing the effect of vaccination on humoral and cellular immune responses to vaccine-specific HIV antigens. Product Description: VRC-HIVDNA016-00-VP is composed of 6 closed, circular DNA plasmids that are each 16.67% (by weight) of the vaccine. Each of the 6 plasmids in this vaccine expresses a single gene product. Plasmids VRC 4401, VRC 4409 and VRC 4404 are designed to express clade B HIV-1 Gag, Pol and Nef, respectively. VRC 5736, VRC 5737, and VRC 5738 are designed to express HIV-1 Env glycoprotein from clade A, clade B, and clade C, respectively. Each DNA vaccination will be 1 mL of vaccine administered intramuscularly (IM) using the Biojector 2000 Needle-Free Injection Management System. Phosphate buffered saline (PBS) will be used as the placebo for the DNA vaccine. VRC-HIVADV014-00-VP (rAd) is a recombinant product composed of 4 adenoviral vectors (Ad) (in a 3:1:1:1 ratio) that encode the HIV-1 Gag/Pol polyprotein from clade B and HIV-1 Env glycoproteins from clades A, B, and C, respectively. Injections of 10(10) PU will be administered IM by needle and syringe. The final formulation buffer (FFB) will be used as the placebo for the rAd vaccine. Subjects: HIV-infected adult volunteers (18-50 years old) on stable highly active antiretroviral therapy (HAART) therapy who have a CD4+ cell count greater than 350 cells/mm3 and have had a viral load (VL) less than 400 copies/mL for at least six months and a viral load of less than 50 copies/mL within 4 weeks prior to enrollment. Study Plan: Fifteen volunteers will be enrolled and randomized in a 2:1 ratio to vaccine:control (10 DNA prime with rAd boost:5 PBS with FFB placebo). A Data and Safety Monitoring Board (DSMB) will review the study every 6 months. Subjects will be evaluated for safety and immunogenicity for 48 weeks, which is 24 weeks after the target date for the booster vaccination. Study Duration: Subjects will be followed for 48 weeks after enrollment into the study.

NCT ID: NCT00264823 Completed - HIV Clinical Trials

Nursing Intervention for HIV Regime Adherence Among People With Serious Mental Illness (SMI)

Start date: June 2003
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to investigate how nurses can best help people with serious mental illnesses (SMI) follow their HIV treatment plans.

NCT ID: NCT00263458 Completed - HIV Clinical Trials

Integrating Buprenorphine Into the SFGH AIDS Program

BHIVES-SF
Start date: December 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the feasibility, cost, and effectiveness of a model of care designed to integrate buprenorphine treatment for opioid dependence into the HIV primary care clinics at the UCSF Positive Health Program.

NCT ID: NCT00258557 Completed - HIV Clinical Trials

TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.

Start date: September 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patients who have never been treated with anti-retroviral medications (referred to as "treatment-naïve" patients).

NCT ID: NCT00255892 Completed - HIV Clinical Trials

Intervention Development for Newly Diagnosed Youth With HIV

Start date: February 2006
Phase: N/A
Study type: Observational

This study is an exploratory qualitative investigation of the challenges, strengths, and needed areas of support associated with receiving an HIV diagnosis among youth living with HIV. Qualitative interviews will be conducted with health care providers who work with adolescents living with HIV and focus groups will be conducted with adolescents who are living with HIV (ages 16-24). One third of the focus groups will be conducted in Spanish. Findings from this study will be used to create an outline and development plan for a culturally-sensitive and developmentally appropriate intervention (or set of interventions) for youth recently diagnosed with HIV.

NCT ID: NCT00255099 Completed - HIV Clinical Trials

TMC125-C216: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.

Start date: December 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is research with the goal of evaluating the effect of TMC125 (a non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus. The study will also investigate whether this new medication is well tolerated, and to further confirm that the medication is safe to be used

NCT ID: NCT00254046 Completed - HIV Clinical Trials

TMC125-C206: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.

Start date: November 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is research with the goal of evaluating the effect of TMC125 (a non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus. The study will also investigate whether this new medication is well tolerated, and to further confirm that the medication is safe to be used.

NCT ID: NCT00253045 Completed - HIV Clinical Trials

Motivating HIV+ Women: Risk Reduction and ART Adherence

KHARMA
Start date: August 2004
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if a group motivational interviewing based intervention will increase adherence to antiretroviral medications and use of risk reduction behaviors.

NCT ID: NCT00250549 Completed - HIV Clinical Trials

A Theory Based HIV Prevention Video For Rapid HIV Testing: A Randomized Trial

Start date: May 2005
Phase: N/A
Study type: Interventional

OraQuick is a safe, rapid test that accurately identifies HIV in as little as 20 minutes. By providing an accurate, quick method for detecting a person's serostatus and access to immediate post-test counseling, rapid testing has a crucial role in identifying HIV status and improving post-test counseling rates in populations who are at high risk of HIV infection and high failure to return rates. This prospective randomized control trial compared the educational effectiveness of a fifteen-minute post-test counseling video with the normal practice of a session with an HIV counselor.

NCT ID: NCT00241202 Completed - HIV Clinical Trials

The Efficacy of the HIV/AIDS Symptom Management Manual

Start date: October 2005
Phase: N/A
Study type: Interventional

The goals of this research are: 1) To test the efficacy of a self-care symptom management manual by examining whether people who use the manual find it to be useful; 2) To examine symptom and demographic data related to self-care behaviors, symptom control, medication adherence and enhanced quality of life. The University of California, San Francisco is the coordinating site for this multi-site international study.