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HIV Infections clinical trials

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NCT ID: NCT00931216 Completed - HIV Infections Clinical Trials

Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya

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

This study seeks to determine the most effective way to reach and provide pregnant women with accessible, comprehensive, and high quality HIV care and treatment.

NCT ID: NCT00929604 Completed - HIV Infections Clinical Trials

HIV Viral Load Monitoring in Resource-Poor Settings

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

No randomized clinical trial to date has demonstrated a survival benefit of using regular HIV-1 ribonucleic acid (RNA) viral load (VL) testing to monitor patients' responses to antiretroviral therapy (ART) for HIV infection. The measurement of VL is recommended to monitor the response to ART in developed countries. In resource-constrained settings, the World Health Organization (WHO) does not recommend routine VL testing, in part due to the cost and complex infrastructure needed for reliable results. In these settings, WHO has proposed the use of clinical and CD4+ lymphocyte-based criteria to guide treatment decisions. However, multiple studies have demonstrated the poor performance of these criteria in sub-Saharan Africa and the frequent discordance between immunologic and virologic responses to ART. The use of routine viral load monitoring should be evaluated in resource-constrained settings. The investigators hypothesize that routine viral load testing of patients on ART will improve patient survival, decrease disease progression and development of drug resistance, and will be feasible and cost-effective for resource-constrained settings.

NCT ID: NCT00928187 Active, not recruiting - HIV Infections Clinical Trials

Evaluation of Three Strategies of Second-line Antiretroviral Treatment in Africa (Dakar - Bobo-Dioulasso - Yaoundé)

2LADY
Start date: November 2009
Phase: Phase 3
Study type: Interventional

Since the first line antiretroviral (ARV) treatment is now largely accessible in the Sub-Saharian Africa countries, documentation of virological failure, drug resistance patterns and second line treatment evaluation are still to be consolidated in settings where viral load monitoring is not available and non-B HIV subtype is predominant. This trial aims at evaluating the efficacy and tolerance of 3 different second line treatment strategies: two recommended by WHO combine two non-nucleoside reverse transcriptase inhibitor associated with a ritonavir boosted protease inhibitor (emtricitabine-tenofovir-lopinavir/ritonavir and abacavir-didanosine-lopinavir/ritonavir); the third strategy combines emtricitabine-tenofovir-darunavir/ritonavir and is not yet evaluated in Sub-Saharian Africa. Darunavir has a potentially superior antiviral efficacy, a better tolerance and its single daily administration may facilitate treatment adherence.

NCT ID: NCT00926146 Completed - HIV Infections Clinical Trials

Hepatitis B Virus (HBV) Prevention for Homeless at Risk for HBV/Hepatitis C Virus (HCV)/HIV

HBV
Start date: July 2009
Phase: N/A
Study type: Interventional

In this study, researchers from UCLA and Friends Community Center will work together in designing a program to assist young homeless stimulant-using gay and bisexual homeless men to complete the hepatitis vaccine and in reducing drug and sexual activity. Using nurse case management strategies, found successful with homeless adults as well as contingency management strategies, found successful with gay and bisexual homeless adults by the community partners, the investigators will evaluate the effectiveness of a program that combines both strategies. As stimulant use threatens to increase homeless persons' risk of exposure to hepatitis A and B viruses, particularly among young users who may not yet be HBV-infected, this research is targeted to engage this group in treatment, until they are suitably protected from HBV, and hopefully reduce risk for HCV and HIV as well.

NCT ID: NCT00926003 Completed - HIV Infections Clinical Trials

Computerized Cognitive Rehabilitation in Ugandan Children With HIV

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

One-hundred and fifty-nine school-age children with HIV in Kayunga District, Uganda were randomized to one of 3 treatment arms: 24 training sessions of a computerized cognitive rehabilitation therapy (CCRT) program called Captain's Log; 24 sessions of Captain's Log not titrated to child's performance; or no training intervention. Study Aim 1: To compare the neuropsychological benefit of 24 training sessions of Captain's Log CCRT to the active and passive control groups over a 8-week period, and at 3-month follow-up. Study Aim 2: To compare the psychiatric benefit of 24 training sessions of Captain's Log CCRT to the active and passive control groups over an 8-week period, and at 3-month follow-up. Study Aim 3: To evaluate how ART treatment status, and the corresponding clinical stability of the child modifies CCRT neuropsychological performance gains and psychiatric symptom reduction. Outcome Assessments: The Kaufman Assessment Battery for Children, 2nd ed. (KABC-2), Tests of Variables of Attention (TOVA) visual and auditory tests, CogState computerized neuropsychological screening test, Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), and Achenbach Child Behavior Checklist (CBCL) will be administered before and after the 8-week training period and at 3-month follow-up post training. Captain's Log has an internal evaluator feature which will help us monitor the specific training tasks to which the children best respond. Analyses: We will compare neuropsychological and psychiatric gains over the 8-week training period and at 3-mo follow-up for our three study groups, anticipating that they will be significantly greater for the CCRT intervention children (Study Aims 1 & 2). These neuropsychological gains will be associated with improved school performance over the long-term. Intervention children clinically stable on ART will have greater gains than those not stable or virally suppressed on ART. Conclusion: CCRT will prove effective and sustainable for enhancing neurocognitive status in HIV children. Futher work will prove this approach viable for assessing and treating children in resource-poor settings.

NCT ID: NCT00925795 Completed - HIV Infections Clinical Trials

Effect of Extra Virgin Olive Oil on Atherosclerosis Biomarkers in HIV-infected Patients

EVOO_HIV
Start date: September 2009
Phase: N/A
Study type: Interventional

HIV infection is associated with systemic inflammation that is involved in pathogenesis of atherosclerosis. Treatment of HIV infection may cause lipid profile disturbance and consequently, atherosclerosis progression. In general, extra virgin olive oil (EVOO) has beneficial effect on atherosclerosis markers. Our goals are to examine the effect of EVOO on atherosclerosis markers in HIV-treated patients. A controlled randomized cross-over study will be performed on 40 participants. They will consume EVOO and ROO (refined olive oil) during two 20 days intervention periods, interrupted with 14 days wash-out period. Before the trial and after both intervention periods we will analyze participants' blood for: ESR, white blood cell count, hsCRP, interleukin-6, oxidized LDL, glutathione peroxidase, superoxide dismutase, malondialdehyde, triglycerides, total cholesterol, HDL and LDL cholesterol, fibrinogen, factor VII and von Willebrand factor. We expect an improvement of these parameters after three weeks of EVOO consumption.

NCT ID: NCT00925756 Completed - HIV Infections Clinical Trials

CCR5 Inhibitor Treatment Intensification on CD4+ T-cell Recovery

Start date: October 20, 2008
Phase: Phase 4
Study type: Interventional

CCTG 590 is a open-label study to evaluate the impact of therapy intensification with Maraviroc (MVC) (a CCR5 inhibitor) to a stable suppressive HIV antiretroviral regimen on the rate of CD4+ T-cell recovery and gene expression profiles. Patients on a stable first-line HIV regimen with continued viral suppression and sub-optimal CD4+ T-cell counts will be eligible for this study. Those who are found to be eligible will have MVC (dose-adjusted to background HIV regimen) added to their current HIV regimen for 24 weeks. After the 24 week intensification, the MVC will be discontinued, the original antiretroviral regimen will be continued and the subjects will be followed for an additional 12 weeks. The investigators hypothesize that MVC will improve the rate of CD4 recovery. This improved CD4 recovery will be associated with favorable changes in gene expression profiles of genes involved with CD4 maintenance and circulation.

NCT ID: NCT00924898 Completed - HIV Infections Clinical Trials

Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805)

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

This is a pilot study of treatment of acute HIV infection with a once daily regimen of Emtricitabine, Tenofovir and Efavirenz. The primary objectives of this study are: 1. To determine the safety and tolerability, and the virologic and immunologic efficacy of FTC, TDF, and efavirenz given once daily to patients with acute HIV infection. 2. To assess the impact of once daily therapy combined with a standardized adherence program on treatment adherence, virologic suppression, and rate of viral load decline in blood and infectious fluids (semen, cervico-vaginal secretions). 3. To define the prevalence of genotypic and phenotypic resistance to antiretroviral agents among persons diagnosed with acute HIV infection in the Southeastern United States.

NCT ID: NCT00924365 Completed - HIV Infections Clinical Trials

Natural History Study of HIV Acquired in Infancy or Childhood

Start date: February 1, 2007
Phase:
Study type: Observational

Background: - About 10,000 children in the United States have been living with HIV infection since birth. Little is known about the long-term effects of HIV infection and its treatment on the growth and development of these children. - Because of their disease, many children with HIV face additional difficulties with their health, well-being and development, such as success in school and peer relationships. Objectives: - To better understand how HIV infection and the medicines used to treat it affect the growth and development of children, adolescents and young adults who have been infected since birth or when they were very young. - To develop ways to improve the quality of life for these individuals. Eligibility: -HIV-infected patients who were followed by the pediatric HIV program in NCI as of December 2004, or an HIV-infected sibling of a participant. Design: - Periodic evaluation of pubertal development; bone mineralization; body composition and fat distribution; liver, kidney and heart status; and behavioral, cognitive and academic or vocational outcome of the study group. Evaluations include the following: - Physical examinations, including height and weight measurements and skin-fold thickness testing to measure body fat. - Review of medical records and family history. - Blood and urine tests, including pregnancy test in females who can bear children. - DEXA scans (X-ray test to measure bone strength and how much fat, muscle and bone is in the body). - Neuropsychological testing, including evaluation of language, thinking and problem-solving abilities. - Magnetic resonance imaging (MRI): Test using a magnetic field and radio waves to examine brain structure and function. - Oral glucose tolerance test: Blood sampling before and one time after the subject drinks a sugary solution to measure the body's ability to use sugar

NCT ID: NCT00921557 Completed - HIV Infection Clinical Trials

Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents

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

HIV-infected children, youth, and adults have lower bone mineral density (BMD) than would be expected for HIV-uninfected people of similar age, weight and race. As the majority of perinatally HIV-infected U.S. children are entering or in adolescence, the potential for HIV-related impaired BMD during the adolescent peak of bone mass acquisition is of particular concern. The primary purpose of this study was to compare changes from pre-treatment levels of BMD of the lumbar spine after 24 and 48 weeks of alendronate treatment with placebo in HIV-infected children and adolescents.