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HIV Infections clinical trials

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NCT ID: NCT01434706 Completed - Acute HIV Infection Clinical Trials

Implementation of Nucleic Acid Amplification Testing Screening to Identify Acute and Early HIV Infection

Start date: September 16, 2010
Phase: N/A
Study type: Interventional

The investigators propose to study the impact of nucleic acid amplification testing (NAT) screening for acute Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV) infections and Less-Sensitive Enzyme linked Immunoassay (LS-EIA) or 'detuned' testing Vironostika, Trinity Biotech BED, or Ortho-Clinical Diagnostic Vistros ECi for early HIV infection in conjunction with routine rapid HIV testing at HIV counseling and testing sites and venues in the San Diego county. The overarching goal of this study is to develop and implement a system to identify, notify and engage into care those individuals with recent HIV infection in order to better define the HIV and Hepatitis C Virus (HCV) epidemics in the San Diego county and to evaluate and characterize HIV transmission dynamics within the San Diego population.

NCT ID: NCT01433601 Active, not recruiting - Clinical trials for Human Immunodeficiency Virus (HIV)

Antiretroviral Treatment Strategies in Relation to Adherence, Resistance and Virological Treatment Failure

DotArv
Start date: August 2007
Phase: N/A
Study type: Interventional

This project aims to assess different antiretroviral treatment strategies, optimally controlled and conventional, in relation to drug resistance and virological treatment failure. A Randomised Controlled trial (RCT) where Vietnamese HIV+ patients with CD4+ T-cells <200/ul are randomized into either enhanced treatment support (ETS) through peer supporters or The National AIDS Control Program recommended self supervised treatment (SST). The treatment strategies will be assessed and compared in relation to treatment adherence and drug resistance development with virological treatment failure as primary endpoint. The results from this project will lead to an increased knowledge in relation the impact of treatment support on adherence, virological suppression and resistance development and have an impact on HIV treatment policies in low income settings globally.

NCT ID: NCT01433289 Completed - HIV Infection Clinical Trials

Study to Evaluate Safety and Toxicity of Polyphenon E (EGCG) in HIV-1-Infected Individuals

Start date: December 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety, toxicity, dosing, and antiviral effects of epigallocatechin gallate (EGCG) in capsule form (Polyphenon® E), administered orally twice daily at three different doses in HIV-1-infected clinically stable, treatment-naïve and treatment-experienced adults not on concomitant antiretroviral (ARV) therapy.

NCT ID: NCT01433185 Completed - HIV Infections Clinical Trials

Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV

SMS4PMTCT
Start date: April 2012
Phase: N/A
Study type: Interventional

Early accurate diagnosis is one of the first crucial steps in care for infants born to HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early diagnosis and results in significant reductions in infant morbidity and mortality. There is little information on evidence-based interventions that specifically target improved attendance of postpartum clinic visits and subsequent infant HIV testing in the context of prevention of mother-to-child transmission of HIV (PMTCT) programs. The investigators propose a randomized controlled trial to examine the effect of text messages sent to women enrolled in PMTCT programs on adherence to postpartum clinic visits and uptake of early infant diagnosis by DNA polymerase chain reaction (PCR). This study seeks to test the hypotheses that (a) text messages sent to women enrolled in PMTCT will improve their attendance at the postnatal clinic within the first 6-8 weeks after childbirth; and (b) text messages sent to women enrolled in PMTCT programs will increase uptake of DNA PCR HIV testing at 6-8 weeks among infants exposed to HIV. This study will evaluate a novel strategy to improve adherence to postnatal clinic visits and increase the uptake of infant HIV testing. If proven superior to standard care, the proposed intervention can be easily scaled-up and integrated into existing healthcare systems in resource-limited settings. Findings from this study will provide randomized trial evidence to inform HIV prevention program planners and implementers. This study will also provide further information on the feasibility of using mobile phone-based technology for public health interventions in resource-limited settings.

NCT ID: NCT01428986 Completed - HIV Infections Clinical Trials

Safety Study of Maraviroc's Effect on Human Osteoclasts

MVC-Bone
Start date: November 2009
Phase: N/A
Study type: Observational

This study is to investigate the safety of maraviroc by examining whether there is bone metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone mineral density and markers for bone formation, desorption and chemokine.

NCT ID: NCT01428596 Active, not recruiting - HIV Infections Clinical Trials

Safety and Immunogenicity of HIVAX in HIV-1 Infected Subjects

GCHT01
Start date: September 2010
Phase: Phase 1
Study type: Interventional

This study is to test a therapeutic HIV-1 vaccine (HIVAX™) in HIV-1 infected subjects. The safety and immune responses will be studied in vaccine recipients. The anti-viral effect of HIVAX vaccine will be monitored during a 12-week treatment interruption phase.

NCT ID: NCT01426243 Completed - HIV Infection Clinical Trials

The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient.

EP46 NOVAA
Start date: July 2011
Phase: Phase 3
Study type: Interventional

Main objective : To develop the tools for evaluation of humoral and cell-mediated immunity after Yellow Fever Vaccine (YFV) and compare virological and immune responses in HIV-positive and HIV-negative individuals who had not been given YFV before. Secondary objectives : - To develop and assess ELISPOT technology for yellow fever and to measure the response within 7, 14, 28, 90 and 365 days of administration of YFV in 30 HIV negative subjects and 40 HIV positive subjects (CD4 > 350/mm3 under Highly Active Antiretroviral Therapy (HAART) for at least one year, with a viral load < 50 copies/mL since at least 6 months) in terms of : (1) seroconversion by fluorescence, (2) cytotoxic response in ELISPOT, (3) neutralizing antibody levels in Plaque reduction neutralization test (PRNT:reference method) and a new pseudotype based method, (4) post-vaccination viremia and (5) diversity of viral quasi-species. - To assess the impact of YFV on the T-lymphocyte response against HIV by ELISPOT and viral load.

NCT ID: NCT01425099 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

Drug Interaction Study Between Dolutegravir and Prednisone

Start date: September 2011
Phase: Phase 1
Study type: Interventional

Dolutegravir (DTG, GSK1349572 is an integrase inhibitor that is currently in Phase 3 clinical development for the treatment of human immunodeficiency virus (HIV) infection. DTG is primarily metabolized by UDP-glucuronosyltransferase (UGT1A1) with cytochrome P450 (CYP)3A4 pathway as a minor route. Corticosteroids have demonstrated induction effects on UGTs and CYP3A4. Corticosteroids are often used in HIV-infected subjects and have the potential to reduce DTG exposure due to enzyme induction when co-administered. The primary objective of this study is to determine whether concomitant prednisone administration can affect the pharmacokinetics (PK) of DTG. The study is a two part, two period, open label study. Part 1 will evaluate the effect of a high prednisone dose on DTG PK with the potential for an additional Part 2 depending on the results from Part 1. In Part 1, approximately 12 healthy subjects will receive DTG 50mg q24h for 5 days in Period 1. Subjects will then be administered DTG 50mg q24h in combination with prednisone 60mg for 5 days followed by a 5 day taper (total duration of 10 days) in Period 2. PK data of DTG will be obtained from Part 1 and used to inform decision making on the need for Part 2. If DTG exposure is reduced by more than 50% in Part 1, Part 2 will be carried out where a second cohort of subjects will receive DTG 50mg q24h DTG for 5 days in Period 1 followed by DTG 50mg q24h in combination with prednisone 20mg for 5 days followed by a 5 day taper (total duration of 10 days) in Period 2. Safety evaluations and serial PK samples for DTG will be collected during each treatment period. A follow-up visit will occur 7-14 days after the last dose of study drug. All doses of study drugs will be taken following a moderate fat meal. This study will be conducted at one center in the United States, with healthy adult male and female subjects.

NCT ID: NCT01425073 Completed - HIV Infections Clinical Trials

Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya

Start date: February 2012
Phase: N/A
Study type: Interventional

Both antiretroviral therapy (ART) and prevention of opportunistic infections (OIs) have been associated with significantly decreased mortality in HIV-infected individuals. Trimethoprim-sulfamethoxazole (TMP/SMZ), also known as bactrim, is a common antibiotic and used as prophylaxis for OIs. For countries with high prevalence of HIV and limited health infrastructure, the WHO endorses universal TMP/SMZ for all HIV-infected individuals. Notably, these guidelines were created prior to the scale-up of ARTs. Following ART and subsequent immune recovery, TMP/SMZ may no longer be required. In the US and Europe, for example, TMP/SMZ is discontinued after patients show evidence of immune recovery. Therefore, we propose a prospective randomized trial among HIV infected individuals on ART with evidence of immune recovery (ART for > 18mo and CD4 >350 cells/mm3) to determine whether continued TMP/SMZ prophylaxis confers benefits in decreasing morbidity (malaria, pneumonia, diarrhea), mortality, CD4 count maintenance, ART treatment failure and malaria immune responses.

NCT ID: NCT01423825 Completed - HIV Infections Clinical Trials

Evaluating the Safety and Immune Response to an HIV Vaccine Boost Following the Administration of Two HIV Vaccines, in HIV-Uninfected, Healthy Adults (Study Extension to HVTN 073/SAAVI 102)

Start date: August 2011
Phase: Phase 1
Study type: Interventional

This is an extension of the HVTN 073/SAAVI 102 study. This study will evaluate the safety and immune response to an HIV envelope protein vaccine boost in people who have previously received the SAAVI DNA-C2 and SAAVI MVA-C vaccines or placebo in the HVTN 073/SAAVI 102 study.