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AIDS clinical trials

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NCT ID: NCT01077310 Completed - Clinical trials for Human Immunodeficiency Virus

Alcohol Pharmacotherapy for HIV+ Prisoners

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

This is a randomized controlled trial of injectable intramuscular naltrexone (XR-NTX) versus intramuscular placebo among HIV-infected prisoners meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. We hypothesize that extended release naltrexone (XR-NTX) will result in improved HIV outcomes (lower log10 HIV-1RNA levels and higher CD4 count) as well as improved alcohol treatment outcomes, and reduced drug/sex HIV related risk behaviors and decreased rates of reincarceration.

NCT ID: NCT01075152 Completed - HIV Infections Clinical Trials

Cryptococcal Optimal ART Timing Trial

COAT
Start date: November 2010
Phase: Phase 4
Study type: Interventional

The Cryptococcal Optimal ART Timing (COAT) trial seeks to determine after cryptococcal meningitis (CM) whether early initiation of antiretroviral therapy (ART) prior to hospital discharge results in superior survival compared to standard initiation of ART started as an outpatient.

NCT ID: NCT01070017 Completed - HIV Infections Clinical Trials

Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

CASA
Start date: February 2010
Phase: Phase 3
Study type: Interventional

Using quantitative and qualitative data, this study will assess the impact of community accompaniment with supervised antiretrovirals (CASA) on HIV-positive individuals and community members in Lima, Peru.

NCT ID: NCT01058694 Completed - HIV Infections Clinical Trials

The Impact of Short Message Services (SMS) on ARV Adherence in Western Kenya

CAPS
Start date: June 2007
Phase: N/A
Study type: Interventional

The purpose of proposed research is to implement a randomized study that will allow us to understand and address a number of key barriers to patient adherence as well as study the effects of better adherence on health and socio-economic outcomes.

NCT ID: NCT01053598 Completed - HIV Infections Clinical Trials

Evaluation Of The Performance Of The Nitrate Reductase And Resazurin Titre Assay For The Detection of Mycobacterium Tuberculosis Complex From Sputum In A High Tb and Hiv Setting

NRA RETA
Start date: September 2011
Phase: N/A
Study type: Observational

The Principle objective of this study is To evaluate the performance of NRA, NRA-p and REMA-p for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB suspects in a high TB and HIV prevalence setting, using LJ and MGIT culture as gold standard. The Secondary objectives are: - To measure the performance of each assay (NRA, NRA-p, REMA-p) in sputum smear-negative patients - To describe the results of the colorimetric methods in HIV-positive and HIV-negative patients - To assess the time to detection of both NRA/NRA-p, REMA-p methods. - To evaluate the feasibility of the NRA, NRA-p, REMA-p methods. - To determine the rate of contamination of the NRA, NRA-p and REMA-p assays. - To evaluate the proportion and the clinical relevance of NTM among TB suspects in a high TB and HIV prevalence setting. - To provide capacity building for TB diagnosis in Mbarara.

NCT ID: NCT01013987 Recruiting - AIDS Clinical Trials

Maraviroc (Celsentri) With Raltegravir and Darunavir/Ritonavir for the Treatment of Triple Class Failure in Adult HIV-1 Infected Patients

TERCETO
Start date: February 2010
Phase: Phase 4
Study type: Interventional

Phase 4, single arm, open label study designed to compare the safety and efficacy of antiviral activity and immunological effect of Maraviroc in combination with Raltegravir and Darunavir/Ritonavir for treatment of triple class failure in adult HIV-1 infected subjects. The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: maraviroc, darunavir and raltegravir in patients who have multi-resistant viruses and limited treatment options. Patients will undergo treatment for 48 weeks; safety and virological efficacy will be preliminary evaluated at weeks 16 and 24.

NCT ID: NCT00986063 Completed - HIV Infections Clinical Trials

Genotype Based Personalized Prescription of Nevirapine

GENPART
Start date: July 2009
Phase: Phase 4
Study type: Interventional

Genetic tests has been suggested to reduce side effects related to Nevirapine(NVP), a commonly prescribed component of highly active antiretroviral therapy(HAART) in developing countries. This clinical trials is designed to determine the efficacy and the cost-effectiveness of this approach in the developing countries setting. NVP-based HAART and efavirenz(EFV)-based HAART will be provided through Thai national universal health coverage. Information of the prescribed drug will be collected, and monitoring for the compliance with the prescribed highly active antiretroviral therapy will be conducted. Outcome measurements: The primary objective of this study is to evaluate the reduction in incidences of NVP associated cutaneous side effects by genotype based personalized prescription. The volunteers will be monitored for any solicited and non-solicited adverse effects for 6 months after drug administration, with first 6 weeks intensive monitoring for cutaneous adverse reactions. Laboratory safety profiles (Complete Blood Count(CBC), Alanine transaminase(ALT), Aspartate transaminase(AST), Blood Urea Nitrogen(BUN), creatinine, direct bilirubin, total bilirubin, lactate dehydrogenase, alkaline phosphatase) will be assessed during the intensive monitoring period (6 weeks). Statistical Methods: Descriptive statistics will be used to evaluate the conduct of the study. Analysis variables will include overall follow-up rate, drug compliance, and events of protocol violation. Laboratory and safety data will be presented using comparative statistics for each study group and compared within and between groups using standard parametric or non-parametric comparison tests, i.e., McNemar's test or paired t-test as appropriate. Comparison of rate of cutaneous adverse reaction, hepatitis and severe cutaneous adverse reaction(SCAR) will be made with chi-square test. Variable that shown significant different between the "standard of care" or control group and the "genetic test" or intervention group will adjusted for the final analysis with Poisson logistic regression. The overall rate of adverse events in all participants will be monitored whether the rate of adverse events is lower than the predefined criteria. The extension of trial may be considered based on the rate of adverse events.

NCT ID: NCT00972725 Completed - AIDS Clinical Trials

Evaluation of the Immune Response of a HIV Candidate Vaccine After Administration of One Chloroquine Dose

Start date: December 1, 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and reactogenicity of one booster dose of a HIV candidate vaccine after administration of one oral dose of chloroquine.

NCT ID: NCT00951795 Withdrawn - HIV Infections Clinical Trials

Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts

Start date: September 2009
Phase: N/A
Study type: Observational

This is a multi-center study designed to assess the accuracy of Pima™ CD4 Test to enumerate CD4+ T-cells in whole blood over the measurement range expected for the intended population. The Pima CD4 Test consists of the Pima™ CD4 cartridge and Pima™ Analyzer to identify and determine the absolute counts of mature helper (CD3+/CD4+) T-lymphocytes in whole blood.

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.