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HIV Infections clinical trials

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NCT ID: NCT00963235 Completed - HIV Infections Clinical Trials

Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS

Start date: November 2009
Phase: Phase 3
Study type: Interventional

The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 18 years of age or older who have been previously immunized with at least one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). All subjects will receive 3 doses of 13vPnC, with each study vaccine dose given approximately 6 months apart.

NCT ID: NCT00962780 Completed - HIV Infections Clinical Trials

Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine

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

The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 6 years of age or older who have not been previously immunized with a pneumococcal vaccine. All subjects will receive 3 doses of 13vPnC and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), with each dose given approximately 1 month apart.

NCT ID: NCT00961883 Completed - HIV Infections Clinical Trials

Safety of and Immune Response to Prime/Boost Vaccine Regimens in Healthy, HIV-1 Uninfected, Ad5 Seronegative Adults

Start date: August 2009
Phase: Phase 1
Study type: Interventional

Investigators will examine the safety of and immune responses to two vaccines expressing synthetic HIV proteins: NYVAC-B (a poxvirus), and rAd5 (an adenovirus). The study will compare responses in participants receiving NYVAC-B first, and rAd5 later, to those who receive rAd5 first, and NYVAC-B later. A different dose of rAd5 will be tested in each group.

NCT ID: NCT00961272 Completed - HIV Infections Clinical Trials

Evaluating the Pharmacokinetics of 400 mg Oral Dose of Raltegravir in HIV-Infected Pre-Menopausal Women

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

The purpose of this study is to characterize the pharmacokinetics of raltegravir in cervicovaginal fluids as compared to blood plasma of HIV-infected pre-menopausal women.

NCT ID: NCT00959894 Completed - HIV Infections Clinical Trials

Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection

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

The main study is a single arm, open-label, prospective study to assess antiretroviral activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-1-infected men and women. There are also a genital secretions pharmacokinetic (PK) sub-study and a metabolic sub-study. The purpose of the genital secretions PK sub-study is to gain information about drug levels and HIV-1 RNA in genital secretions when subjects are taking etravirine. The purpose of the metabolic sub-study is to learn about the effects of etravirine on body composition, as well as lipid and glucose levels.

NCT ID: NCT00959699 Completed - HIV Infections Clinical Trials

A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)

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

The primary objective of this trial is to compare the efficacy of boceprevir (SCH 503034) 800 mg three times a day (TID) orally (PO) in combination with peginterferon alfa-2b (PegIFN-2b) 1.5 µg/kg weekly (QW) subcutaneously (SC) plus weight-based dosing (WBD) of ribavirin (RBV) (600 mg/day to 1400 mg/day) PO to therapy with PegIFN-2b + RBV alone in adult participants coinfected with human immunodeficiency virus (HIV) and previously untreated chronic hepatitis C virus (HCV) genotype 1. Boceprevir is a potent, orally administered, novel serine protease inhibitor, specifically designed to inhibit the HCV nonstructural protein 3 (NS3) protease and, thereby, inhibit viral replication in HCV-infected host cells. The mechanism of inhibition represents a new mechanism of action compared to both interferon alfa and ribavirin. Based on previous experience with PegIFN-2b and RBV in combination with boceprevir in the HCV-monoinfected population, this combination treatment is expected to provide significant benefit to the HIV/HCV coinfected population. Given the high unmet medical need of these participants and the benefit of the addition of boceprevir to PegIFN-2b/RBV, it is important to demonstrate the safety and efficacy of boceprevir in combination with PegIFN-2b/RBV in participants coinfected with HIV/HCV. This is a randomized, multi-center trial, double-blinded for boceprevir or placebo in combination with open-label PegIFN-2b/RBV in participants coinfected with HIV and previously untreated chronic HCV (genotype 1), to be conducted in conformance with Good Clinical Practice (GCP). This trial consists of two arms, one control arm (Arm 1) and one experimental arm (Arm 2). Participants in the control arm (Arm 1) may receive boceprevir/PegIFN-2b/RBV via a crossover arm.

NCT ID: NCT00959413 Completed - HIV Infections Clinical Trials

Assessing HIV-Related Oral Mucosal Disease and Using Saliva to Measure Viral Load

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

The mouth may play an important part in monitoring HIV progression. Mucosal lesions of the mouth are often the first sign of infection and their development in already diagnosed individuals indicates disease progression. In addition, saliva may provide a non-invasive way to track viral load. The purpose of this study is to establish standardized practices for examining the mouth and identifying oral mucosal lesions as well as to establish a correlation of viral load with HIV particles found in saliva.

NCT ID: NCT00959361 Completed - HIV Infections Clinical Trials

Evaluation of Effectiveness of Pharmaceutical Care on the Adherence of HIV-Positive Patients to Antiretroviral Therapy

PC-HIV
Start date: June 2006
Phase: N/A
Study type: Interventional

INTRODUCTION: Studies prove that the pharmaceutical care (PC) increases the adherence to the antiretroviral; thus, they increase the undetectable viral load. The viral load diminishes, and the prevalence of undetectable viral load increases, as the levels of adherence to the treatment increase, being in general necessary high adhesion to reach the effectiveness therapeutic. Increasing the adherence levels, it increases the surviving chances and quality of life and diminishes the transmission risks. Studies demonstrate that the self-effectiveness expectation to use the medication correctly is the main predictor of adherence, and that the more complex the therapeutic regimen is, and the perception of side effects, the smaller the adherence is, highlighting the importance of preventing, identifying and solving the problems during the treatment with antiretroviral, problems related to the medication (PRM) through the PC. OBJECTIVES: To evaluate the effectiveness of the PC on the adherence of HIV-patients to the antiretroviral therapy, identify, prevent and solve PRMs during the treatment. METHODOLOGY: One-side randomized clinical trail controlled by non-intervention in parallel. 332 patients randomized are included in the control and intervention groups (PC). Questionnaires will be applied: sociodemographic, adherence to the antiretroviral through self-report, smoke, BECK (depression), CAGE (problems related with alcohol consumption) of self-effectiveness, expectation of results and social support. Each 4 months measure of viral load and CD4 will be carried out. The ones from the PC group will receive a card with information about the medication and all the medicines will be identified by different colors. The follow-up will last one year according to the instructions of DADER program.

NCT ID: NCT00959166 Completed - HIV Infections Clinical Trials

To Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection

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

This study plans to evaluate what happens to the brain in patients with HIV and early hepatitis C. The investigators will be comparing 3 groups of individuals: - Group 1: Individuals with HIV infection and acute (early) hepatitis C infection - Group 2: Individuals with HIV infection - Group 3: Healthy volunteers

NCT ID: NCT00959088 Completed - HIV Infections Clinical Trials

Faster Identification of TB and Evaluation of Drug Resistance in HIV-infected People

FASTER
Start date: August 2009
Phase: N/A
Study type: Observational

Early identification of tuberculosis (TB) is of particular importance in HIV-infected individuals, as a delay of therapy can be devastating in those with compromised immune systems. Diagnosis of TB in HIV is difficult, however, because 24-61% of HIV co-infected individuals with pulmonary TB have negative TB test results. In addition, conventional testing can take 6 weeks or longer and may not be available at all in many settings. This study is being conducted to see whether some new tests for identifying TB and for identifying resistance to TB drugs are at least as accurate as the current testing methods when used on HIV-infected individuals. The study will also assess whether the new tests can provide accurate results faster than the current methods.