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HIV Infections clinical trials

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NCT ID: NCT00838162 Completed - Clinical trials for Human Immunodeficiency Virus Type 1

A Study to Determine the Antiviral Activity of TMC310911 When Administered With Ritonavir in Treatment-Naive Human Immunodeficiency Virus - Type 1 (HIV-1) Infected Patients

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

The purpose of this study is to evaluate the antiviral activity as measured by the change in viral load from baseline in the 14 days following initiation of treatment with 4 different dose regimens of TMC310911 co-administered with ritonavir.

NCT ID: NCT00836550 Completed - HIV Infections Clinical Trials

Video-based Counseling & Rapid HIV Testing for Teens

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

This study evaluated the educational effectiveness of a youth-friendly pre-test video (derived from a previous qualitative study) and compared it with in-person HIV pre-test counseling. A convenience sample of 200 medically stable individuals between the ages of 15 and 21 presenting to an urban ED were recruited to participate in this study and randomized into 2 groups. Individuals were eligible if they were English-speaking, sexually active and able to consent. All participants completed a sexual risk factor and demographic survey. Group 1 completed a validated pre-test knowledge measure, viewed the HIV education video then completed a post-test knowledge measure. Group 2 completed the same knowledge measures, but received pre-test HIV counseling from a trained public health advocate. HIV testing was optional

NCT ID: NCT00836290 Completed - HIV Infections Clinical Trials

Positive Lifestyles Using Safety

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

Project PLUS tests an HIV risk reduction/adherence behavioral intervention with HIV-infected individuals in Connecticut prisons. Participants are randomly assigned to one of three groups: prior to release from incarceration (Group 1), after release from incarceration (Group 2), and treatment-as-usual (Group 3). We hypothesize that the intervention groups (Groups 1 & 2) will demonstrate significantly greater knowledge regarding drug- and sex- related HIV risk behavior and HIV medication adherence, greater motivation to reduce HIV risk behavior and improve HIV medication adherence, and enhanced skills for engaging in HIV risk reduction behavior and HIV medication adherence vs. the treatment-as-usual group. We will also compare these outcomes between Groups 1 and 2.

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: NCT00833781 Completed - HIV Infections Clinical Trials

A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects

PARC002
Start date: August 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to find out whether an experimental autologous dendritic cell vaccine is safe, well tolerated, and whether it can strengthen the immune system's response to HIV.

NCT ID: NCT00833482 Completed - HIV Infections Clinical Trials

Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants

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

This study assesses the effects of voriconazole, 200 mg, administered twice daily (BID), on the steady-state pharmacokinetics of atazanavir administered as atazanavir/ritonavir, 300/100 mg once daily (QD), in healthy participants with functional CYP2C19 alleles. The study also reviews the effects of atazanavir/ritonavir, 300/100 mg QD, on the pharmacokinetics of voriconazole, 200 mg, BID in healthy participants with functional CYP2C19 alleles.

NCT ID: NCT00830856 Completed - HIV Infections Clinical Trials

Early Versus Delayed Antiretroviral Therapy (ART) in the Treatment of Cryptococcal Meningitis in Africa

Start date: October 2006
Phase: N/A
Study type: Interventional

Cryptococcal Meningitis continues to be one of the most devastating AIDS defining illness in sub-Saharan Africa. Despite the availability of azoles such as fluconazole for treatment, mortality remains high with some studies showing 100% mortality. The investigators designed a study to determine if timing of the initiation of antiretroviral therapy (ART) in patients with cryptococcal meningitis and HIV would improve survival. The investigators hypothesis was that early initiation of ART result in improved mortality for patients with HIV and cryptococcal meningitis.

NCT ID: NCT00830622 Completed - HIV Infections Clinical Trials

Cell Phone Intervention to Support Antiretroviral Therapy (ART) Adherence in Kenya

Start date: May 2007
Phase: N/A
Study type: Interventional

A clinical study to evaluate the use of cell phones to support drug adherence and follow-up of patients taking antiretroviral therapy (ART) for treatment of HIV. The intervention involves health-care providers sending regular short-message-service (SMS) text messages to patients and following up their responses. The hypothesis is that the cell phone intervention will improve ART adherence and health outcomes compared with the current standard of care.

NCT ID: NCT00829114 Completed - HIV Infections Clinical Trials

Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)

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

Non-randomized, comparative study (1:1 allocation) to study interactions between nevirapine-containing antiretroviral therapies and combined oral contraceptive pills.

NCT ID: NCT00829010 Completed - Clinical trials for Infections, Streptococcal

Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age.

Start date: February 17, 2009
Phase: Phase 3
Study type: Interventional

The purposes of this study: - To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants following a 3-dose primary vaccination at 6, 10 and 14 weeks of age and following booster vaccination at 9-10 months of age. - To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV unexposed uninfected infants receiving either a 3-dose primary vaccination according to the EPI vaccination schedule at 6, 10 and 14 weeks of age with or without booster vaccination at 9-10 months of age or a 2-dose primary vaccination at 6 and 14 weeks of age followed by booster vaccination at 9-10 months of age. - This study also aims to assess the impact of the pneumococcal vaccine GSK1024850A on nasopharyngeal carriage of S. pneumoniae and H. influenzae up to 24 months of age in all study participants.