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HIV Infections clinical trials

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NCT ID: NCT00810108 Completed - HIV Infections Clinical Trials

Lopinavir/Ritonavir (Kaletra) PK in Children

Start date: June 2006
Phase: Phase 4
Study type: Interventional

The objective of this study is to compare the pharmacokinetics of lopinavir tablets administered to pediatric patients as either whole or crushed tablets. The study is a randomized,open-label, crossover study of pediatric subjects already taking lopinavir/ritonavir tablets as part of their clinical care. THe investigators hypothesize that lopinavir exposure in pediatric patients will be lower after taking a dose of the tablet formulation, crushed and mixed with pudding or yogurt, as compared to the exposure after taking a dose with tablets swallowed whole.

NCT ID: NCT00808002 Completed - HIV Infections Clinical Trials

Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine

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

The intensification with maraviroc in recently HIV-1-infected patients of a preferred gold-standard triple therapy composed of raltegravir plus tenofovir/emtricitabine could accelerate the decay of the HIV-1 reservoir in latently infected cells established early in HIV-1 infection. This could provide further insight into this area, decrease the size of latent reservoir, and translate into clinical benefits for patients.

NCT ID: NCT00807625 Completed - HIV Infections Clinical Trials

Impact of Different Contraceptives on the Immune System of HIV Infected Women in Zambia

MSRC
Start date: November 2008
Phase: Phase 2
Study type: Interventional

In this study, 66 HIV-infected women who desire contraception will be randomly assigned to use either an IUD or Depo Provera, and will be followed for six months. The study is intended to help investigators understand potential mechanisms by which hormonal contraception may hasten HIV disease progression.

NCT ID: NCT00807443 Completed - HIV Infections Clinical Trials

Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1

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

The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with a viral load below 50 copies/mL is the main limitation to eradication of the virus from the body. This viral reservoir prevents antiretroviral therapy from being interrupted; therefore, patients are obliged to continue with treatment for a period calculated to be greater than 60 years. Despite the important advances in knowledge of the biology of this reservoir, we still have no real knowledge about its dynamics. The opportunity to carry out a clinical trial for the first time with an integrase inhibitor is exceptional, since the results could provide important information on the nature of this reservoir. If maintenance of the reservoir is a dynamic process, inclusion of an integrase inhibitor is expected to lead to a reduction in the size of this reservoir. This effect could be critical when including IAT (viral reactivation), since, in theory, it would be necessary to act on a smaller reservoir. Current consensus is that it would be necessary to act on almost 100% of the viral reservoir (approximately 1,000,000 cells). The study has also been designed to enable us to understand the biochemical and molecular mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body.

NCT ID: NCT00806845 Completed - HIV Infections Clinical Trials

Examination of B Cell Responses in Human Blood

Start date: July 2008
Phase: N/A
Study type: Observational

The aim of this study is the assessment B-cell immune responses in HIV-infected individuals.

NCT ID: NCT00803543 Completed - HIV Infections Clinical Trials

Seroprevalence of HSV-2 in HIV Infected Subjects and the Effect of Daily Valacyclovir in the Reduction of HSV-2 Recurrence and Viral Shedding

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

The purpose of the study is to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily secretions.

NCT ID: NCT00802802 Completed - HIV Infections Clinical Trials

Efavirenz (EFV) in HIV-Infected and HIV/Tuberculosis (TB) Coinfected Children

Start date: February 10, 2010
Phase: Phase 1
Study type: Interventional

Efavirenz (EFV) is an anti-HIV medicine that is commonly used to treat HIV infection in adults and children older than 3 years of age. This study is being conducted to look at the safety of EFV, blood levels of EFV, genetic factors that may affect blood levels of EFV, and how easy it is for infants and young children to take and tolerate EFV. This information will help recommend the best doses of EFV for children younger than 3 years of age.

NCT ID: NCT00801879 Completed - HIV Infections Clinical Trials

Mupirocin Ointment to Eliminate Nasal Carriage of Staphylococcus Aureus in HIV Infection

Start date: September 2003
Phase: Phase 4
Study type: Interventional

Staphylococcus aureus is a bacteria that causes serious, often life threatening infections including pneumonia, wound, and bloodstream infections. Persons with AIDS are at high risk for S. aureus infections. They are also at high risk for nasal carriage of S. aureus. In fact, nasal carriage is a known risk factor for subsequent S. aureus infection. Topical mupirocin, an antibiotic when applied to the anterior nares, is a safe, effective way to eliminate S. aureus colonization. Some studies have shown that mupirocin can also decrease the risk of S. aureus infection, but many of those studies utilized historical controls and none were rigorously tested among AIDS patients over an extended period of time. The main purpose of this randomized, double-blinded, placebo controlled study is to determine if mupirocin can eliminate S. aureus nasal colonization in residents at PSI (inpatient, drug rehabilitation facility for AIDS patients in the Bronx.) PSI residents currently have a high incidence of S. aureus nasal colonization and infection. Nasal cultures followed by twice daily application of mupirocin vs. placebo for five days will be performed on a monthly basis for 8 months. the study will examine whether mupirocin decreases the incidence of S. aureus infections and prevents S. aureus nasal colonization. The study is important because it may show that mupirocin is an effective way to eliminate nasal colonization and prevent S. aureus infections in AIDS patients, among those at highest risk for serious S. aureus infection. Hypothesis: Monthly application of mupirocin will reduce nasal colonization with S.aureus

NCT ID: NCT00801697 Completed - HIV Infections Clinical Trials

Safety and Immune Response to Preventive HIV Immunization With Adenovirus Serotype 5 or 35 Vector

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

This study will evaluate the safety and preliminary immune response to recombinant adenoviral serotype 35 and 5 HIV-1 vaccines in HIV-uninfected adults.

NCT ID: NCT00799136 Completed - HIV Infections Clinical Trials

A Feasibility Study of Co-administering Combination Antiretroviral Therapy (cART) and R-EPOCH Chemotherapy for the Management of ARL

CATCH
Start date: February 2008
Phase: Phase 2
Study type: Interventional

No standard regimen currently exists for the treatment of AIDS-related lymphoma. Based on the encouraging NCI results with DA-EPOCH, the US AIDS Malignancy Consortium is currently administering a phase II randomized protocol comparing EPOCH with sequential versus concurrent rituximab (AMC protocol 034). In this AMC trial, the decision to co-administer cART is left to the discretion of the treating physician and the patient. While the AMC phase II study may establish an acceptable chemotherapy regimen suitable for further study in a phase III randomized trial, the results will not address adherence, pharmacokinetic interactions or the role of cART in AIDS-related lymphoma. The contribution of cART to the anti-lymphoma efficacy of any regimen needs to be formally studied. Our proposed trial to demonstrate the feasibility of co-administering cART with chemotherapy would justify the use of combined therapy in future AMC/International phase III protocols.