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HIV Infections clinical trials

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NCT ID: NCT01187979 Completed - HIV Infections Clinical Trials

Reducing HIV in Adolescents

RHIVA
Start date: September 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the impact of a cash-incentivised prevention intervention on reducing HIV incidence rates in high-school learners in rural KwaZulu-Natal.

NCT ID: NCT01187719 Completed - Pregnancy Clinical Trials

The Effect of Phenytoin on the Pharmacokinetics of Nevirapine and the Development of Nevirapine Resistance

VITA 2
Start date: May 2010
Phase: Phase 2
Study type: Interventional

The primary objective of this two-phase trial is as follows: - To determine the elimination half-life of NVP in HIV positive pregnant women receiving it as a single dose in labour in addition to the ZDV and 3TC with or without seven days phenytoin (pilot PK phase) - To determine NVP resistance in HIV positive pregnant women receiving it as a single dose in labour in addition to ZDV and 3TC with or without seven days phenytoin (main trial phase) The secondary objectives of this two-phase trial are as follows: - To determine the safety of single dose nevirapine with seven days phenytoin as a part of ARV prophylaxis for PMTCT vs. single dose of nevirapine without phenytoin as a part of ARV prophylaxis for PMTCT - To determine the HIV status of the infant - To determine the safety of the ARV prophylaxis for PMTCT with seven days of phenytoin on the newborn Hypothesis: phenytoin reduces the elimination half life of SD NVP and thereby decreases development of resistance to NVP in HIV positive pregnant Tanzanian and Zambian women.

NCT ID: NCT01186575 Completed - HIV Infections Clinical Trials

Text Messaging to Improve Adherence to Clinic Visits and Reduce Early Resumption of Sexual Intercourse After Male Circumcision

Start date: August 2010
Phase: N/A
Study type: Interventional

Male circumcision (MC) reduces, by more than half, the risk of HIV-1 acquisition. WHO and UNAIDS recommend that "male circumcision should be recognized as an efficacious intervention for HIV prevention especially in countries and regions with heterosexual HIV epidemics and low male circumcision prevalence." As a result, programs have been introduced and scaled up for voluntary medical male circumcision. Kenya leads with the largest expansion of services. Early resumption of sexual intercourse after MC may have deleterious effects, including higher rates of post-operative surgical complications, and higher HIV acquisition among females in couples that resume sexual activity before certified wound healing. In the context of rapid scale-up of MC, adherence to post-operative clinic appointments allows clinicians to assess wound healing and to deliver risk reduction counseling. Abstinence from sexual intercourse before complete wound healing would reduce the rate of post-operative adverse events and minimize the risk of HIV transmission from HIV-infected men to their uninfected female partners. To the investigators knowledge, the effect of reminders delivered via text messaging to promote adherence to clinic visits and abstinence after MC has not been investigated. The investigators propose a randomized controlled trial in which men who will have undergone voluntary medical male circumcision at selected sites in Kisumu will be randomized to receive either the intervention (context-sensitive text messages after circumcision) or the control condition (usual care). This study seeks to determine (a) the effect of regular text messages sent to men after circumcision on attendance of the scheduled 7-day post-operative clinic visit versus usual care; (b) the proportion of men who resume sexual activity before 42 days post-procedure after receiving regular text messages versus usual care within the 42 days post-circumcision; and (c) to identify potential predictors of failure to attend the scheduled 7-day post-operative visit and early resumption of sexual intercourse.

NCT ID: NCT01186042 Completed - HIV Clinical Trials

Chronic HIV Infection and Aging in NeuroAIDS (CHAIN)

CHAIN
Start date: August 1, 2010
Phase:
Study type: Observational

The purpose of this study is to find the best tests to use to investigate the differences between older and younger people with HIV disease. Test to be included will measures of memory, learning, activity levels, sleep patterns, emotional well-being and sexual health.

NCT ID: NCT01184456 Completed - HIV Infection Clinical Trials

A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune System

Start date: August 2010
Phase: Phase 2
Study type: Interventional

Improvement in the rate of bacterial translocation may lead to a decrease in a chronic inflammatory response thereby decreasing CD4 destruction and HIV proliferation. By the addition of probiotics we hope to show a reduction in LPS leading to a decrease in chronic inflammation and therefore an improvement in immune markers.

NCT ID: NCT01180075 Completed - Clinical trials for Human Immunodeficiency Virus

Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population

Start date: May 2010
Phase: N/A
Study type: Observational

Purpose: To see how growing older changes the amount of HIV drugs in the blood of HIV-infected men and women. Many changes happen in the body as it ages that may affect the way drugs are carried in the blood, broken down or removed from the body. This study will look at the amount of drug in the blood and cells of the immune system for patients taking efavirenz, tenofovir and emtricitabine or atazanavir boosted with ritonavir, tenofovir and emtricitabine. Participants: The population will comprise of 56 (6 for intensive PK and 50 for sparse sampling) HIV-infected adults currently adhering to an antiretroviral regimen containing efavirenz with tenofovir and emtricitabine and the same number and distribution of HIV-infected adults currently adhering to an antiretroviral regimen containing atazanavir boosted with ritonavir with tenofovir and emtricitabine. Procedures (methods): This study will be completed at the University of North Carolina at Chapel Hill. There will be four groups of subjects: Efavirenz/tenofovir/emtricitabine Group A, Efavirenz/tenofovir/emtricitabine Group B, Atazanavir/ritonavir/tenofovir/emtricitabine Group A, and Atazanavir/ritonavir/tenofovir/emtricitabine Group B. The initial six subjects (Group A) for intensive PK analysis for each regimen will be recruited from the the UNC ID Clinic or the Moses Cone Health System Infectious Diseases Clinic, and will be comprised of non-frail subjects not currently receiving interacting drugs. If subjects provide informed consent, timed blood samples will be obtained to determine pharmacokinetic parameters around an observed dose of one of the two study regimens. A whole blood sample will also be collected and stored for potential drug metabolizing enzymes and transporters genotyping in the future. Group A subjects will complete a follow-up visit after their sampling visit. 50 subsequent subjects (Group B) for each regimen will be screened simultaneously, with no more than 10 subjects enrolled for each regimen in Group B prior to the completion and analysis of Group A. These subjects will also be recruited from either site. Group B subjects will have one or two sampling visits with 1 to 4 blood samples obtained at each visit, with a stored sample for future genotyping obtained on one of the visits. Samples will be collected just prior to a dose, at 2 hours, between 4 and 6 hrs, and between 10 and 14 hours after a medication dose. These visits may coincide with the subjects' regularly scheduled visit to the clinic, or be scheduled separately, depending on the preference and availability of the subject.

NCT ID: NCT01171495 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

Impact of Nutrition Intervention on HIV/AIDS Infected Patients

INI
Start date: April 2008
Phase: Phase 3
Study type: Interventional

Intervention to investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.

NCT ID: NCT01170741 Completed - Clinical trials for Human Immunodeficiency Virus

Computer-Assisted Tailored Cue-card Health [CATCH] Study

CATCH
Start date: June 2010
Phase: Phase 1
Study type: Interventional

This study will draw from proven interventions to refine and pilot test a cue card driven computer-assisted intervention, along with HIV/STI testing, that will be tailored to each participant's demographic characteristics, risk behaviors, and biological test results. The specific aims of the proposed study are: 1. To refine a cue card driven computer-assisted risk reduction intervention that will be tailored to each participant's demographic characteristics (e.g., gender, ethnicity), risk behaviors, and biological test results (HIV, hepatitis B and C, syphilis and herpes). 2. To pilot test the tailored intervention's effects on sexual risk behaviors (e.g., frequency of unprotected sex, condom use), drug use during sex and injection risk behaviors (e.g., direct syringe sharing, indirect sharing practices) using a two-group randomized design that compares the tailored intervention with a delayed treatment control condition. 3. To assess the feasibility and acceptability of the tailored intervention in a rural setting.

NCT ID: NCT01165203 Completed - Herpes Zoster Clinical Trials

Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects

Start date: September 30, 2010
Phase: Phase 2
Study type: Interventional

This observer-blind study will evaluate the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine GSK1437173A in Human Immunodeficiency Virus (HIV) infected subjects, firstly enrolling subjects treated with antiretroviral therapy (ART) and with high CD4 T cell counts, and subsequently ART-treated subjects with low CD4 T cell counts, and ART-naïve subjects with high CD4 T cell counts. This Protocol Posting has been updated following Amendment 1 of the Protocol, August 2010. The impacted sections is exclusion criteria.

NCT ID: NCT01164462 Completed - HIV Infections Clinical Trials

Feasibility and Limitations of Offering Community Based Rapid HIV Testing to Men Who Have Sex With Men (MSM)

DRAG
Start date: March 2010
Phase: N/A
Study type: Interventional

Objective: This research agreement brings together French and Canadian teams of scientists, HIV testing centers and community based partners. The aim is to explore the feasibility and limitations of offering community based rapid HIV testing to men who have sex with men (MSM).