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HIV Infections clinical trials

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NCT ID: NCT00885664 Completed - HIV Infections Clinical Trials

Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection

Start date: October 2005
Phase: Phase 4
Study type: Interventional

The purposes of this study are: 1. To understand whether the use of HIV therapy in persons with more advanced HIV disease results in greater side effects. 2. To determine whether these side effects can be related to greater activation of the immune system.

NCT ID: NCT00885625 Recruiting - Clinical trials for Invasive Pneumococcal Disease

7-valent Pneumococcal Conjugated Vaccination

PCV
Start date: March 2009
Phase: Phase 4
Study type: Interventional

Hypothesis: the efficacy of 2 doses 7-valent PCV is equivalent to 1 dose 7-valent PCV.

NCT ID: NCT00885495 Completed - HIV Infections Clinical Trials

Darunavir/Ritonavir and Rosuvastatin Pharmacokinetic Study

Start date: January 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I, open-label, controlled drug interaction study to determine the effects of darunavir plus ritonavir on the pharmacokinetics of the hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, rosuvastatin, in HIV-1-seronegative subjects.

NCT ID: NCT00885482 Completed - HIV Infections Clinical Trials

Atazanavir and Lamivudine for Treatment Simplification

AtLaS
Start date: May 2009
Phase: Phase 4
Study type: Interventional

Objectives of the study: 1. To verify the safety of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with ritonavir. 2. To collect relevant information about the safety and the metabolic impact of this strategy in order to eventually design a non-inferiority randomized controlled trial for the evaluation of the safety and the efficacy of this strategy in the future.

NCT ID: NCT00885287 Completed - HIV Infections Clinical Trials

Interactions Between Artemether-lumefantrine and Antiretrovirals in HIV-patients With Uncomplicated Malaria in Tanzania

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

As HIV/AIDS is spreading in malaria-endemic countries, many patients here will need concomitant treatment for both infections. Effective combination treatments are available for both malaria (artemisinin-based combination treatments, ACTs) and HIV/AIDS (antiretroviral combination treatments, ARTs), and these treatments are presently recommended for concomitant use by ministries of health in many endemic countries, including Tanzania. However, theoretically some of these drugs may be involved in harmful interactions with each other, as they share common cytochrome enzymes involved in their metabolism. Such interactions could lead to less effective treatments and/or adverse effects, as a consequence of reduced or increased drug levels, respectively. Only little clinical and pharmacological information is however yet available to guide clinicians and policy-makers on this issue. The main aim of the InterACT study in Tanzania is to conduct a series of detailed observational studies of clinical and paraclinical safety, therapeutic efficacy and pharmacokinetic interactions between the currently nationally recommended first-line treatment for malaria, artemether-lumefantrine, and first-line antiretroviral treatments, primarily nevirapine-based combinations, for HIV/AIDS. The studies will be conducted among patients with uncomplicated malaria, who attend the HIV/AIDS Care and Treatment Clinic and Muheza Designated District Hospital in Muheza, north-eastern Tanzania, which is an area characterized by intense transmission of Plasmodium falciparum malaria and with a prevalence of HIV around 8-10%. The study is expected to inform guidelines for the treatment of malaria in patients with HIV/AIDS in Tanzania, and elsewhere.

NCT ID: NCT00884858 Completed - HIV Infections Clinical Trials

Maraviroc in Immunological Non-Responder (INR) HIV-1-infected Subjects

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

Suboptimal improvement in cluster of differentiation 4 (CD4) cell count is not uncommon in HIV-1-infected patients with suppressed plasma HIV-Ribonucleic acid (RNA) levels, and a decrease in CD4 cell count in patients with suppressed or low level viremia has been observed. Although the efficacy of current antiretroviral medications is well established, some antiviral combinations are very effective in suppressing HIV-1 load whereas do not exert any effect on immune reconstitution. Both T-cell immune activation and fibrosis of peripheral lymphoid tissue could create an environment in which CD4 T cell count decrease in the setting of low or suppressed plasma viremia is likely to occur. Another fascinating hypothesis, which has still to be elucidated, is that reconstitution of the depleted CD4 pool is blocked by an excess of glycoprotein 120 (gp120) HIV-1 protein. This extra-production could be counteracted by an inhibitor of the chemokine (C-C motif) receptor 5 (CCR5) co-receptor that represents one of the major docking tools of HIV-1. With this in mind, the investigators would like to propose and design a pilot exploratory clinical trial involving a population of HIV-1-infected patients that rapidly reached a virologic suppression without a reconstitution of their immune system.

NCT ID: NCT00884793 Completed - HIV Infections Clinical Trials

Pilot Study on the Effect of Adding Raltegravir +/- a Second Drug on HIV Levels in the Gut

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

The "PLUS" study is a pilot study to measure the effect of therapy intensification (with raltegravir and optional second agent) on HIV levels in the gut and blood in patients on antiretroviral therapy (ART) with viral load < 50 copies/mL (herein referred to as "suppressed"). We hypothesize that there is ongoing replication in the gut despite suppressive ART and that this replication can be inhibited by the addition of one or two new antiretroviral drugs whose activity affects a distinct part of the viral life cycle. All study participants will have upper and lower endoscopy at baseline (before intensification) and after intensification. These endoscopies will be used to obtain gut tissue and single cells (for CD4+ cells) .

NCT ID: NCT00881699 Completed - HIV Infections Clinical Trials

Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil

Start date: September 2006
Phase: Phase 3
Study type: Interventional

This study will test the effectiveness of a program aimed at reducing behaviors that increase HIV risk among people with severe mental illnesses.

NCT ID: NCT00879047 Completed - HIV Infections Clinical Trials

Interaction of Alcohol and Highly Active Antiretroviral Therapy (HAART) in HIV/AIDS and HIV/AIDS With Hepatitis C Virus (HCV) Co-Infection

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

The proposed studies will examine the extent of pharmacokinetic and pharmacodynamic interactions between alcohol and various antiretroviral therapies in those with HIV/AIDS, HIV/HCV co-infection, mild HCV and healthy subjects.

NCT ID: NCT00878306 Completed - HIV Infections Clinical Trials

Disulfiram Interactions With HIV Medications: Clinical Implications

Start date: November 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether disulfiram might be a safe and effective treatment for cocaine and/or alcohol dependence in patients with HIV disease. This research is designed to characterize the presence or absence of significant drug interactions between disulfiram and HIV medications using standard clinical pharmacology techniques as well as monitor any side effects that might occur when these medications are administered together.