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HIV Infections clinical trials

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NCT ID: NCT02686853 Not yet recruiting - Clinical trials for Cryptococcal Meningitis

Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis

Start date: January 2016
Phase: Phase 4
Study type: Interventional

The main purpose of this study is to observe the clinical effect of intrathecal administration of liposomal amphotericin B in Cryptococcal Meningitis without Acquired Immune Deficiency Syndrome (AIDS).

NCT ID: NCT02511496 Not yet recruiting - Chronic Hepatitis C Clinical Trials

Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia

Start date: September 2015
Phase: N/A
Study type: Observational [Patient Registry]

This study evaluates the current situation and follow-up of chronic hepatitis C virus (HCV) infection in patients co-infected with human immunodeficiency virus (HIV) in Andalusia.

NCT ID: NCT02008214 Not yet recruiting - HIV Infections Clinical Trials

Efficacy of PTX+IFN Alpha+ RBV on Hepatitis C Virus Coinfected HIV Patients

Start date: December 2013
Phase: Phase 4
Study type: Interventional

Current Hepatitis C virus (HCV) treatment consists of the combination of interferon alpha 2a (IFN-alpha 2a) plus ribavirin (RBV) and it provides sustained virologic responses (SVR) on 54 to 56% on HCV monoinfected patients and this response is even lower on HIV-HCV coinfected patients. A previous study on HCV monoinfected patients showed that the addition of pentoxyfylline (PTX) to a treatment scheme based on interferon-alfa and ribavirin increased SVR on 25%, although it is not known if the same effect is to be obtained in HCV-HIV coinfected patients. On the other hand, other factors such as host genetics, have proved to influence treatment response on HCV infected patients. The best described genetic factor so far is the interleukin 28B (IL28B) polymorphism rs12979860, where a cytosine-cytosine (CC) genotype provides an almost twice increase on SVR than the rest of the genotypes. Therefore, this is a randomized, double blind study to assess the efficacy of pentoxyfylline addition to a treatment scheme based on interferon-alfa and ribavirin in chronic HCV genotype 1, co-infected HIV-1 positive subjects, considering the IL28B polymorphism rs12979860. HIV-HCV coinfected subjects currently receiving Highly active antiretroviral therapy (HAART), with at least 8 months on undetectable HIV viral load and T helper cells count of 200 or higher will be included. Patients will be randomized on one of two groups: - Group A: IFN alpha 2a + RBV + PTX - Group B: IFN alpha 2a + RBV + placebo Patients will be followed for primary outcome during 72 (for rapid responders) or 96 weeks (for non rapid responses). Outcome measures will be the following: - SVR rate 24 weeks after the end of treatment - Grade of Hepatic fibrosis from baseline to the end of treatment, measured by transient elastography and the AST to platelet ratio index (APRI index) - IL28B rs12979860 genotype The study hypothesis is that the addition of PTX to a treatment scheme based on IFN-alfa2a and RBV in chronic HCV genotype 1, co-infected HIV-1 positive subjects will improve SVR rate and fibrosis progression irrespectively of IL28B rs12979860 genotype.

NCT ID: NCT01697046 Not yet recruiting - HIV Clinical Trials

A Pilot Study on Raltegravir, Tenofovir and Emtricitabine for Peri-exposure Prophylaxis for HIV Infection

PERIEP
Start date: November 2012
Phase: Phase 3
Study type: Interventional

This will be a pilot, open label study involving 65 participants. All participants will be followed until seroconversion or until the last enrolled participant completes one year of follow-up, whichever happens first. Participant study number will be given at the screening visit, prior to inclusion in the study. The chosen intervention and study regimen are based on the dynamics of viral infection and the pharmacokinetics of the study drugs. In order to inhibit reverse transcription nucleoside and nucleotide analogues need to be phosphorylated intracellularly. On the other hand, available data indicate that it takes approximately 10 hours between exposure and HIV viral integration, offering a window of opportunity for Raltegravir to block integration and thus prevent infection, given that this drug does not need to be metabolized to exert its effect. The intervention will be maintained for 4 weeks following exposure, in accordance with Brazilian and CDC guidelines for PEP.

NCT ID: NCT01541631 Not yet recruiting - Anemia Clinical Trials

A Study of Co-infections of HIV-1 and Schistosoma Mansoni and Its Impact on Praziquantel Treatment Outcomes

Start date: May 2012
Phase: N/A
Study type: Interventional

In this study, it is hypothesized that helminth infections modulate immune responses against HIV-1 infection resulting into increased HIV-1 multiplication, faster progression to AIDS and increased episodes of AIDS-related opportunistic infections. Furthermore, the effect of helminth infections on progression of HIV-1 infection is dependent on helminth infection intensity, host background immunity, nutritional status, demographic factors and socio-economic status. Also, treatment of helminth infections using praziquantel and albendazole among HIV-1 infected individuals will lead to reduction in HIV-1 viral loads, improvement of CD4+ counts, CD4+/CD8+ ratio and Hb levels, improved weight gain and reduction of episodes of HIV-1 related opportunistic infections. In addition, HIV-1 infection is associated with poor anthelminthic treatment outcome as compared to non-HIV infected individuals

NCT ID: NCT01444690 Not yet recruiting - Clinical trials for Acquired Immunodeficiency Syndrome

Dimiracetam in Painful Neuropathies Affecting AIDS Patients

DIPANAP
Start date: January 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and tolerability of orally administered dimiracetam for 10 weeks to AIDS patients under treatment with antiretroviral agents presenting a disease and /or treatment related neuropathic pain.

NCT ID: NCT01343225 Not yet recruiting - HIV Clinical Trials

Effect of a Non-tenofovir, Non-efavirenz-based HIV Regimen on Bone Density and Vitamin D Levels in African-American Patients With HIV Infection

Start date: May 2011
Phase: Phase 4
Study type: Interventional

2. Objectives 1. To determine the vitamin D status of African-American HIV patients who are HIV-treatment naïve. 2. To compare the effects of an efavirenz-containing regimen to a protease inhibitor regimen on 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3 levels. 3. To compare the effect on bone density of a tenofovir- and efavirenz-containing regimen to a regimen that does not contain these drugs. 4. To compare the efficacy of an alternative regimen (raltegravir, darunavir, ritonavir) to a standard once-daily regimen (tenofovir-emtricitabine-efavirenz). Hypothesis The investigators hypothesize that patients receiving efavirenz will be more likely to have lower 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3levels based on the fact that efavirenz is an inducer of CYP3A4 and CYP24 enzymes that degrade 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3, respectively, to inactive metabolites. The investigators speculate that patients on a tenofovir-containing regimen will be more likely to have progression of bone density loss compared to those in the non-tenofovir-containing regimen.

NCT ID: NCT01318096 Not yet recruiting - HIV Infections Clinical Trials

Safety and Efficacy of Raltegravir+TDF+3TC in HBV/HIV Co-infected Patients

Start date: March 2011
Phase: N/A
Study type: Interventional

In this pilot study, the investigators would examine the safety and efficacy of integrase inhibitor-Raltegravir in the control of HIV/HBV co-infection.

NCT ID: NCT01293513 Not yet recruiting - HIV Infections Clinical Trials

Structured Treatment Interruption (STI) in Acute/Primary HIV

Start date: February 2011
Phase: N/A
Study type: Interventional

Although the introduction of Highly Active Anti-Retroviral Therapy - HAART - has dramatically altered the course of HIV/AIDS, true cure is still unattainable and patients are required to take these medications for the rest of their lives. As is well known, the prolonged use of such agents is associated with serious, sometimes life-threatening side effects, metabolic disturbances such as diabetes and an increased incidence of myocardial infarction. In 1999, a patient with acute HIV infection was treated soon after diagnosis ("Berlin patient"). However because of intercurrent conditions, treatment was interrupted on two occasions. After the third introduction of therapy, treatment was terminated (arbitrarily) and the patient was found to have undetectable virus throughout a follow up of approximately 18 months. The possible explanation of this phenomenon was autovaccination. Other workers have tried Structured Treatment Interruption (STI) in Acute/Primary HIV Infection with controversial results, possibly because there were too few cycles of treatment interruption. In a patient treated in our center for Acute HIV infection, after initial HAART therapy, he underwent gradually increasing interruptions of treatment from 1 to 7 weeks. After complete cessation of treatment, the patient was followed for 3 years, where CD4 levels were normal, CD4/CD8 ratio remained above 1 and the viral load was undetectable. Our plan is to study patients with Acute/Primary HIV Infection, who have been treated with HAART for at least one year. Once they have been shown to have undetectable virus (less than 40 copies HIV RNA per milliliter) and CD4 above 500 per microliter with a CD4/CD8 above 1, they can be enrolled in the STI study. The study will comprise 6 groups of 4 cycles of treatment/interruption with an increasing duration treatment interruptions alternating with treatment intervals over a 33 month period. Altogether there will be 24 treatment interruptions, lasting from 1 week to 6 weeks. During this time the patients will be regularly monitored for clinical events and laboratory parameters. The purpose of the study is to determine whether patients with acute/primary HIV infection undergoing graded STI can achieve a normal immune status and undetectable viral load on a long-term basis.

NCT ID: NCT01279005 Not yet recruiting - HIV Infections Clinical Trials

Risk Taking Behaviour in MSM and the Denial of Sexually Transmitted Diseases and HIV

MSM HIV
Start date: February 2011
Phase: N/A
Study type: Observational

Four focus groups , each of 10-15 males, ages 20-50 years old, MSM will be conducted by a medical sociologist. Two groups will be HIV negative participants and two groups of HIV positive MSM. Every group will meet for two hours. The focus group will be recorded and the collected data will be processed further for evaluation and extraction of the relevant information. The volunteers will sign an inform consent prior to entrance to the study.