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HIV Infections clinical trials

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NCT ID: NCT02431767 Completed - HIV Infections Clinical Trials

Evaluating the Safety and Immunogenicity of PENNVAX®-GP DNA Vaccine and IL-12 Plasmid, Delivered Via Intradermal or Intramuscular Electroporation in Healthy, HIV-Uninfected Adults

Start date: August 2015
Phase: Phase 1
Study type: Interventional

The study will evaluate the safety and tolerability of the PENNVAX®-GP HIV-1 DNA vaccine and interleukin 12 (IL-12) DNA adjuvant, given by intradermal (ID) or intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.

NCT ID: NCT02431273 Completed - Clinical trials for Human Immunodeficiency Virus (HIV) Prophylaxis

Safety and Pharmacokinetic Study of HIV Prophylaxis Using Antiretroviral Intravaginal Rings in Healthy Women

Start date: June 2015
Phase: Early Phase 1
Study type: Interventional

This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and maraviroc (MVC), in healthy women when used in the following drug combinations: 1) TDF ("Single" IVR); 2) TDF-FTC ("Dual" IVR) and; 3) TDF-FTC-MVC ("Triple" IVR). TDF = tenofovir disoproxil fumarate; FTC = emtrcitabine; MVC = maraviroc

NCT ID: NCT02429791 Completed - HIV Infections Clinical Trials

Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-1)

Start date: April 14, 2015
Phase: Phase 3
Study type: Interventional

The aim of this study is to determine if virologically suppressed human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will participate in the Early Switch Phase where they will either switch from their CAR to DTG + RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible participants will proceed to the Late Switch Phase where all participants in both DTG + RPV and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148, subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study is planned to be conducted in approximately 476 participants.

NCT ID: NCT02427204 Completed - Clinical trials for Hepatitis C Infection

Outcomes in Liver Disease Patient With and Without HIV Co-infection-Sub Study 2: HCV Treatment: Health Related Quality

Start date: June 2015
Phase:
Study type: Observational

The main questions being addressed are (1) how patient reported outcomes change during treatment for HCV, (2) how treatment impacts liver function and liver status, and (3) how much treatment costs from the payer's perspective and the patient's perspective. The hypothesis being tested is that treatment has a negative effect on the quality of life during treatment. The negative effect is expected to be temporary. Successful treatment, which is equated with a virological cure of the infection, is expected to result in an improvement in quality of life compared to baseline and to improvement in markers of liver function and liver status. Costs of treatment are expected to be $80,000-$200,000 per virological cure.

NCT ID: NCT02426840 Completed - HIV Infection Clinical Trials

Calcium and High-dose Vitamin D Supplementation on Bone Mineral Density Among HIV-infected Children and Adolescents

CAL-D
Start date: April 2015
Phase: Phase 3
Study type: Interventional

Since there is no cure for HIV, therefore antiretroviral therapy must be taken life-long. Some of the HIV medications can negatively impact the health of the bone and is even more exacerbated in perinatally HIV-injected children and adolescents because this is the period when the bone peaks. Bone loss during this period can be devastating and increase the risk for developing weak bones later in life. Supplementation of calcium and vitamin D have not been well studied in HIV-infected children and adolescents in developing countries. Therefore it is not clear whether higher doses of these supplementations can thwart the damages or not.

NCT ID: NCT02422797 Completed - HIV Infections Clinical Trials

Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-2)

Start date: April 21, 2015
Phase: Phase 3
Study type: Interventional

The aim of this study is to determine if virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will participate in the Early Switch Phase where they will either switch from their CAR to DTG + RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible participants will proceed to the Late Switch Phase where all participants in both DTG + RPV and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148, subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study is planned to be conducted in approximately 476 participants.

NCT ID: NCT02421159 Completed - HIV/AIDS Clinical Trials

Hybrid STTR Intervention for Heterosexuals: Anonymous Testing and Confidential Care Linkage

BCU
Start date: February 2015
Phase: N/A
Study type: Interventional

The Brooklyn Community United (BCU) study is a supplement to the main research study titled "Peer Driven Intervention to Seek, Test, & Treat Heterosexuals at High Risk for HIV." The main study's field name is Brooklyn Community Action Project (BCAP) (R01DA032083, R#: 11-01257). The main study is testing two approaches to seeking out undiagnosed HIV infection (Venue-based Sampling (VBS) and Confidential Two-Session Testing with Navigation (CTTN-RDS)). HIV prevalence rates in two previous heterosexual cycles of NHBS in the local area are: 7% in HET1 and 12.3% in HET2. The main study, BCAP, found lower prevalence rates of 3.45%, 35.14% of which were newly diagnosed in the RDS-CTTN sample and 1.89% newly diagnosed with HIV in the VBS sample. The primary aim of the Brooklyn Community United (BCU) study is to seek out individuals with undiagnosed HIV using a streamlined RDS-CTTN approach, and anonymous HIV Testing in Central Brooklyn. The supplement study hypotheses are: (H1): Compared with VBS and RDS-CTTN, and controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN participants will have less HIV testing experience. (H2) Controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN will yield higher rates previously undiagnosed HIV compared with VBS and RDS-CTTN. (H3): Most participants (> 70%) found to be HIV-infected in the RDS-ASTN intervention will engage in the Treat and Retain intervention phase. (H4): Most participants in the Treat and Retain phase of the RDS-ASTN intervention (> 70%), all of whom will be HIV infected, will be linked to care within 3 months.

NCT ID: NCT02419456 Completed - HIV Infections Clinical Trials

Pharmacokinetics of Two Intravaginal Rings (IVRs) Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048

Start date: June 2015
Phase: Phase 1
Study type: Interventional

Intravaginal rings (IVRs) may offer an ideal way to deliver antiretroviral (ARV) drugs to prevent HIV infection. This study will evaluate the pharmacokinetics and safety of two IVRs containing different doses of a combination of two HIV ARV drugs, vicriviroc (VCV) (MK-4176) and MK-2048, in healthy, HIV-uninfected women.

NCT ID: NCT02413645 Completed - HIV-infection Clinical Trials

A Phase I, Open Label Dose Escalation Study to Evaluate Safety of iHIVARNA-01 in Chronically HIV-infected Patients Under Stable Combined Antiretroviral Therapy

Start date: June 2015
Phase: Phase 1
Study type: Interventional

The mai purpose of the study is to evaluate the safety and to establish the recommended dose of iHIVARNA-01 as a new therapeutic vaccine against HIV

NCT ID: NCT02411630 Completed - HIV Infection Clinical Trials

Factors Affecting PrEP Adherence

Start date: June 2013
Phase: N/A
Study type: Observational

The purpose of this study is to test a new way to take a questionnaire that asks about adherence (whether the person is taking the medicine correctly). This new questionnaire is called Interactive Questionnaire System (iQS). In this study, the iQS will be tested on HIV-negative young men who have sex with men (YMSM) who are taking PrEP as part of another study, either ATN 110 or ATN 113.