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NCT ID: NCT00986063 Completed - HIV Infections Clinical Trials

Genotype Based Personalized Prescription of Nevirapine

GENPART
Start date: July 2009
Phase: Phase 4
Study type: Interventional

Genetic tests has been suggested to reduce side effects related to Nevirapine(NVP), a commonly prescribed component of highly active antiretroviral therapy(HAART) in developing countries. This clinical trials is designed to determine the efficacy and the cost-effectiveness of this approach in the developing countries setting. NVP-based HAART and efavirenz(EFV)-based HAART will be provided through Thai national universal health coverage. Information of the prescribed drug will be collected, and monitoring for the compliance with the prescribed highly active antiretroviral therapy will be conducted. Outcome measurements: The primary objective of this study is to evaluate the reduction in incidences of NVP associated cutaneous side effects by genotype based personalized prescription. The volunteers will be monitored for any solicited and non-solicited adverse effects for 6 months after drug administration, with first 6 weeks intensive monitoring for cutaneous adverse reactions. Laboratory safety profiles (Complete Blood Count(CBC), Alanine transaminase(ALT), Aspartate transaminase(AST), Blood Urea Nitrogen(BUN), creatinine, direct bilirubin, total bilirubin, lactate dehydrogenase, alkaline phosphatase) will be assessed during the intensive monitoring period (6 weeks). Statistical Methods: Descriptive statistics will be used to evaluate the conduct of the study. Analysis variables will include overall follow-up rate, drug compliance, and events of protocol violation. Laboratory and safety data will be presented using comparative statistics for each study group and compared within and between groups using standard parametric or non-parametric comparison tests, i.e., McNemar's test or paired t-test as appropriate. Comparison of rate of cutaneous adverse reaction, hepatitis and severe cutaneous adverse reaction(SCAR) will be made with chi-square test. Variable that shown significant different between the "standard of care" or control group and the "genetic test" or intervention group will adjusted for the final analysis with Poisson logistic regression. The overall rate of adverse events in all participants will be monitored whether the rate of adverse events is lower than the predefined criteria. The extension of trial may be considered based on the rate of adverse events.

NCT ID: NCT00979706 Completed - HIV Clinical Trials

Immune-based Therapy Pilot Study for the Treatment of Primary HIV Infection (PHI-IMD).

PHI-IMD
Start date: March 2005
Phase: Phase 4
Study type: Interventional

Pilot study for the treatment of primary HIV infection with the objective to induce a strong specific HIV immune response able to control viral replication without HAART.

NCT ID: NCT00972192 Completed - HIV Clinical Trials

Effectiveness of Inpatient Voluntary Counseling and Testing (VCT) in Uganda

Start date: February 2004
Phase: N/A
Study type: Interventional

This study compared the effectiveness of inpatient routine VCT to referral for post-discharge VCT in terms of the number of new HIV infections identified, linkage to care for HIV infected individuals and reduction in HIV risk behavior.

NCT ID: NCT00968188 Completed - HIV Infections Clinical Trials

Internet-based HIV/STI Prevention for Young MSM Receiving HIV Testing

KIU
Start date: August 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to develop an empirically validated, scientifically-based HIV and STI prevention program that can be delivered online to young men who have sex with men (YMSM) who were recently tested for HIV.

NCT ID: NCT00966329 Completed - HIV Infections Clinical Trials

Switching the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) or Protease Inhibitor (PI) to Maraviroc in HIV Subjects

Start date: October 2009
Phase: Phase 4
Study type: Interventional

Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir or ATV/unboosted or 1 NNRTI, will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.

NCT ID: NCT00965185 Completed - HIV Infections Clinical Trials

Statin Therapy to Improve Atherosclerosis in HIV Patients

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

In HIV patients, statin therapy will attenuate plaque inflammation, thus, making plaques less vulnerable, will deter plaque progression, and improve endothelial function. In addition to known cholesterol-lowering and C-reactive protein lowering effects, immunomodulatory effects of statins will lead to a shift from pro-inflammatory monocyte and T cell subsets to less atherogenic subpopulations.

NCT ID: NCT00960622 Completed - HIV Clinical Trials

Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects

TRU
Start date: August 2006
Phase: Phase 4
Study type: Interventional

Study subjects receiving the antiretroviral drugs Combivir or trizivir, will be randomized to switch to Truvada-containing highly active antiretroviral therapy (HAART) or to continue on Combivir or on trizivir. Measurements will be performed at baseline and after 6 months after randomization to either continuing on trizivir or combivir, or to switching to Truvada. Measurements include maximal or peak oxygen consumption, lactate production and clearance, subcutaneous adipose tissue and limb fat contents, insulin resistance, liver and muscle fat contents, and plasma free fatty acid concentrations. The hypothesis underlying this study is that chronic therapy with thymidine analogue nucleoside reverse transcriptase inhibitors (NRTIs), including zidovudine (AZT), leads to clinically detectable mitochondrial dysfunction in several organ systems.

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: NCT00951028 Completed - Depression Clinical Trials

Therapy Targeting Depression and HIV Treatment Adherence (The TRIAD Study)

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

This study will test a therapy for both helping people adhere to their HIV medication regimens and treating them for depression.