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HIV Infections clinical trials

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NCT ID: NCT00941083 Recruiting - HIV Infections Clinical Trials

Simplification From Protease Inhibitors to Raltegravir

ODIS
Start date: January 2009
Phase: Phase 4
Study type: Interventional

A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically and immunologically. Moreover, it will be associated with significant improvements in the lipid profile in HIV patients with undetectable viremia on PIs. In this setting, RAL once a day (QD) will perform as well as RAL twice a day (BID).

NCT ID: NCT00910936 Recruiting - HIV Infections Clinical Trials

Exercise for Patients With HIV Infections

Start date: May 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators will evaluate the effects of an endurance exercise program on the physical performance, the well being, and indicators of metabolic function in patients with an HIV infection.

NCT ID: NCT00889395 Recruiting - HIV Infections Clinical Trials

Cognitive and Psychosocial Benefits of MISC Training for Ugandan Children

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

The Mediational Interventions for Sensitizing Caregivers (MISC) model developed by Professor Pnina Klein is to enhance the cognitive and social development of children throughout the developing world . Although MISC has proven effective in a longitudinal study in two poorer communities of Addis Ababa, Ethiopia , it has not been used with HIV households or in the Ugandan context where there is desperate need for enhanced caregiving in HIV-affected families. We propose to work with community leaders, healthcare workers, and parents/caregivers in adapting MISC to the Ugandan cultural and social context in Kayunga. For intervention families, MISC training will be added to an ongoing home health care visit (HHCV) program already in place for HIV children in Kayunga district. We will then evaluate whether MISC parent/caregiver training improves cognitive and psychosocial development in their children, and whether clinical stability of the HIV child is an important modifier for MISC training benefit.

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: NCT00843661 Recruiting - HIV Infections Clinical Trials

Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients

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

- The aim of the study is to compare the effects of coadministration of ezetimibe 10 mg/die + fenofibrate 200 mg/die versus pravastatin 40 mg/die monotherapy in HIV-infected patients treated with protease inhibitors. - Single-centre, open, randomized, controlled, prospective pilot study. - 60 patients will be enrolled in order to reach the target of 50 patients evaluable at the end of the study. The patients will be randomly assigned to a 6-month treatment with ezetimibe+fenofibrate or with pravastatin.The visit will be every month.

NCT ID: NCT00840762 Recruiting - HIV Infections Clinical Trials

A Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication

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

The investigators seek to determine whether Virco®TYPE HIV-1 provides benefits equivalent to those provided by local expert review. The investigators propose that clinic patients of the Ruth M. Rothstein CORE Center who are having genotypic testing performed will be randomized in a 1:1 fashion to local expert review and to Virco®TYPE HIV-1. Results of either method will be shared with primary HIV care providers. Patient outcomes will be reviewed at a time point equal to or greater than 2 months and 6 months following the change in antiretroviral medications following the testing

NCT ID: NCT00836212 Recruiting - HIV Infections Clinical Trials

Adjusting Antiretroviral Therapy Dosage Using Therapeutic Drug Monitoring

TDM
Start date: March 2008
Phase: Phase 4
Study type: Interventional

Background Low concentrations of protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs) are associated with an increased risk of virological failure. Likewise, excessive antiretroviral drug concentrations increase the risk of toxicity. Therapeutic drug monitoring (TDM) may identify and correct excessively high or low PI and/or NNRTI concentrations, and thus minimize toxicity and risk of treatment failure. Treatment guidelines only recommend using TDM to help optimize ARV therapy in selected patients, and there are no clear recommendations to guide the clinician who decides to adjust drug doses. Prospective studies have demonstrated the relationship between EFV plasma concentration and neuropsychiatric symptoms. Moreover, EFV is metabolized mainly by cytochrome P450 2B6 and its concentration was reported to be associated with the CYP2B6 516GrT genetic polymorphism. For drugs such as EFV or LPV/r, lower doses than the ones validated for standard clinical use have demonstrated efficacy in dose-ranging studies. The investigators will use a standardised algorithm to reduce doses in patients with plasma EFV or LPV/r concentration above percentile 75. This algorithm is based on a Bayesian approach from the pharmacology unit in Lausanne. The investigators hypothesize that a dosage individualisation is feasible and safe. 2.2 Study Aims The investigators aim at testing a simplified algorithm for dose reduction in patients with documented virological efficacy, treated by a stable LPV/r or EFV based regimen with elevated plasma concentration of these drugs. Study Design Prospective open label study in which all eligible patients screened with a plasma drug concentration of either EFV or LPV/r above percentile 75 will be included. After confirmation of the results at baseline, patients will be offered to decrease drug dosage by a third or a half according to a standardised algorithm. All patients will undergo HIVRNA, biochemistry and validated questionnaires after 3 and 6 months to assess the safety and the benefit of this strategy.

NCT ID: NCT00825929 Recruiting - HIV Infections Clinical Trials

Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.

PANNA
Start date: February 2009
Phase:
Study type: Observational

Due to the potential for pregnancy-induced changes in the pharmacokinetics of medication, one cannot assume that the currently licensed doses of the medication to be tested under this protocol lead to adequate exposure in an HIV-infected pregnant woman. For the agents under study no or limited pharmacokinetic data during pregnancy are available. As the changes in pharmacokinetics during pregnancy are most prominent in the third trimester a pharmacokinetic curve will be recorded in the third trimester after attaining steady state.

NCT ID: NCT00796263 Recruiting - Acute HIV Infection Clinical Trials

Antiretroviral Therapy for Acute and Chronic HIV Infection

AAHIV
Start date: April 2009
Phase: Phase 3
Study type: Interventional

This is a protocol designed to randomize subjects with acute HIV infection to receive standard HAART or mega-HAART for subject who are enrolled in SEARCH 010 study (protocol title: Establish and characterize an acute HIV infection cohort in a Thai high risk population. To describe the impact of standard HAART versus mega-HAART initiated during the acute HIV infection period on immunological and virological outcomes.

NCT ID: NCT00796146 Recruiting - Acute HIV Infection Clinical Trials

Establish and Characterize an Acute HIV Infection Cohort in a High Risk Population

Start date: April 2009
Phase:
Study type: Observational

To describe clinical, immunological, and virological characteristics of persons with acute HIV infection 1. To describe demographics and behavioral risk factors for those identified with acute HIV infection 2. To describe neurocognitive function and neuroimaging findings in acute HIV infection as well as describe immune response, HIV-1 genotypes and sequences in the cerebrospinal fluid. 3. To describe the number and characteristics of sexual contacts 4. To describe the willingness of acute HIV-infected subjects to allow the tracking of their sexual contacts for voluntary HIV counseling and testing (VCT) 5. To describe immune response, HIV-1 genotypes and sequences in the genital compartment 6. To describe T cell depletion in the gut mucosa in acute HIV infection and describe the changes in gut T cell during follow up 7. To archive samples for future investigations including determination of viral evolution, and cell-mediated and humoral immune responses in peripheral blood and mucosal compartments