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Acquired Immune Deficiency Syndrome Virus clinical trials

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NCT ID: NCT02542020 Recruiting - Liver Cirrhosis Clinical Trials

Prospective Evaluation of HIV Patients Using Non-invasive Methods for Estimation of Liver Fibrosis and Steatosis

Prospec-HIV
Start date: June 2015
Phase:
Study type: Observational

Human immunodeficiency virus (HIV) infection is a major global health issue with up to 40 million people infected worldwide. Due to highly active antiretroviral therapy, mortality related to acquired immunodeficiency syndrome (AIDS) has been reducing in the last decades. However, liver disease remains as an important cause of severe complications and death. Hepatic fibrosis progression is the main responsible for liver-related outcomes in HIV-positive patients. Co-infection by hepatitis B (HBV) or hepatitis C virus (HCV) is highly prevalence in HIV patients. Chronic viral co-infection induces faster liver fibrosis progression compared to mono-infected HIV. However, published data have been reporting presence of significant liver fibrosis in HIV without HBV or HCV infection. This might be related to direct action of HIV in hepatocytes or association with others factors, such as non-alcoholic fatty liver disease (NAFLD). NAFLD is associated with metabolic factors, such as obesity and type-2 diabetes mellitus. However, antiretroviral drugs may induce abnormal body fat distribution (lipodistrophy) and insulin resistance playing an important role on this process. Liver biopsy has been historically considered as the gold standard to evaluate liver injury. However, this painful method presents several limitations. Therefore, several non-invasive methods for estimation of liver fibrosis, such as biomarkers (APRI, FIB-4, FibroTest and FibroMeter) and transient elastography by Fibroscan, have been developed as an alternative to liver biopsy. The diagnostic performance and prognostic value of biomarkers and transient elastography have been validated in patients with chronic liver diseases. However, few data are available in HIV patients, especially in those without chronic viral co-infection. Therefore, patients, medical doctors and scientific community will be beneficiated by the future application of non-invasive methods for estimation of liver injury in clinical practice in HIV patients.

NCT ID: NCT02337322 Active, not recruiting - Clinical trials for Acquired Immune Deficiency Syndrome Virus

Immune Recovery in Advanced , ARV-naïve, HIV-1-infected Individuals Taking Dolutegravir or Ritonavir-boosted Darunavir

Start date: March 31, 2015
Phase: Phase 4
Study type: Interventional

There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing 2 parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of 2 different combinations of antiretroviral therapy given once a day (QD): abacavir plus lamivudine plus either dolutegravir, or darunavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.

NCT ID: NCT02266992 Recruiting - Clinical trials for Acquired Immune Deficiency Syndrome Virus

Exploring Novel Mechanisms of Vaccine Failure LAIV Pilot Study

LAIV
Start date: September 2014
Phase: Phase 2
Study type: Interventional

Influenza ('flu) can cause severe infections, especially in people with weakened immune systems such as those with HIV. For this reason, yearly vaccination is recommended with the standard 'inactivated' influenza vaccine to try and prevent infections in these populations. It is also recommended in all health care workers, to help prevent the spread of influenza within healthcare settings. However, having HIV infection may mean vaccines work less well in some people and the investigators do not completely understand why. An alternative to the standard 'inactivated' annual influenza vaccine is the 'live attenuated influenza vaccine' (LAIV), which means it consists of weakened versions of the influenza virus. Unlike the standard vaccine, which is given by injection, LAIV is a spray that is given into each nostril. It is now given to children in the UK in preference to the standard vaccine as it results in greater protection from influenza. In some other countries, like the USA, adults are also given LAIV, where it seems to work just as well as the standard vaccine. A few studies in the past have shown that LAIV is safe and effective in HIVinfected children and adults. The investigators want to give LAIV to HIVinfected and HIV negative individuals, to try to find out new information about how HIV infection may change the way in which people respond to vaccines. The investigators will do this by comparing both the early genetic response to the vaccines and later responses from cells specifically targeted to fight influenza ('Tcells'), in these groups. In the long term, the investigators hope that this will lead to designing new ways of improving the response to vaccines in HIVinfected people. As LAIV is given into each nostril, rather than an injection, the investigators also want to see if LAIV results in Tcells in the lung that are specifically targeted to fight influenza

NCT ID: NCT01976715 Recruiting - Clinical trials for Human Immunodeficiency Virus

Study of People With HIV Infection Who Have High Viral Loads Despite Combination Antiretroviral Therapy

Start date: February 11, 2014
Phase:
Study type: Observational

Background: - The human immunodeficiency virus (HIV) causes acquired immune deficiency syndrome (AIDS). Combination antiretroviral therapy (ART) drugs treat HIV infection. They generally decrease the amount of HIV virus in the blood (called viral load) to very low levels. This happens only if the drugs still fight HIV and if taken every day exactly as prescribed. When not taken as directed, or if the ART drugs are not strong enough, the virus can become resistant to them, and the ART will not work to control the virus. Researchers want to know how to control HIV in people who can t lower their viral load with their current ART drugs. Objective: -<TAB>To better control HIV in people who can t get a lower viral load even with ART drugs and to learn more about why the HIV is not under control. Eligibility: - People at least 18 years old and with HIV. - People who have been on at least two combinations of ART drugs (including current ART). - People whose last two viral loads were greater than 1,000 copies/mL. Design: - Participants will be screened with medical history, physical exam, and blood tests. - Participants will then have a baseline visit. They will have another physical exam, blood tests, plus answer questions about what they know about HIV and ART, and how they take their ART. - Participants will arrange to stay in the NIH hospital for 7 8 days. - They will take their medications as usual. At the time to take the ART drugs, they will have to ask a nurse to bring them. If they forget, the nurse will bring them. - Participants will meet with a doctor, pharmacist, social worker and nurse to discuss ways to help participants remember to take their drugs. - Participants will have blood drawn about every other day. - Researchers will study the test results. Some participants will be put on different ART drugs. If that happens, participants will have another NIH hospital stay for 7-8 days. - Participants will have 4 follow-up visits over 12 weeks, then every 3 months for 2 years or more.

NCT ID: NCT01840722 Completed - Hepatitis C Clinical Trials

Brief Intervention for Rural Women at High Risk for HIV/HCV

WISH
Start date: December 2012
Phase: N/A
Study type: Interventional

The overall aim of this study is to reduce risk behaviors and increase health and behavioral health service utilization among disadvantaged, drug-using rural women at high risk for HIV and HCV. This project has potential to make a significant contribution to science by providing knowledge about the health, risk behaviors, and service utilization of a vulnerable and understudied group of women during a time of emerging and significant public health risk in a rural Appalachian setting. Successful completion of the aims of this project will advance the delivery of a low-cost, potentially high impact intervention with implications for a number of other real world settings (such as criminal justice venues) where other disadvantaged high-risk drug users can be identified and targeted for intervention.

NCT ID: NCT01766076 Completed - Clinical trials for Acquired Immune Deficiency Syndrome Virus

Atorvastatin for HAART Suboptimal Responders

Start date: January 2013
Phase: Phase 3
Study type: Interventional

We hypothesise that atorvastatin changes immune activation among HAART-treated adults with suboptimal cluster cell differentiation 4 (CD4) recovery by 25%

NCT ID: NCT00974519 Recruiting - HIV Infections Clinical Trials

The Effect of Combination of Traditional Chinese Medicine (TCM) and Highly Active Antiretroviral Therapy (HAART) on Immune Reconstitution of HIV/AIDS Patients

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

Immunity 1 (Fuzheng 1) is composed of herbs which have tonic and detoxific function. The long-term clinical application has proved the safety and effect. It can improve the symptoms and signs in AIDS patients with the effective rate of 70% and can significantly improve the quality of life. It can also improve and stabilize immune function and inhibit viral replication. The basis study have shown that Immunity 1 (Fuzheng 1) can inhibit viral replication from multi-target, multi-link, enhance immune function, increase the secretion of IL-2, IFN-γ, participate in immune regulation effect, enhance NK cell activity, promote CD3+CD4+T cell proliferation and increase macrophage phagocytes capacity.

NCT ID: NCT00974454 Recruiting - HIV Infections Clinical Trials

Research on Effect of Traditional Chinese Medicine (TCM) on Immune Reconstitution of HIV/AIDS Patients After Highly Active Antiretroviral Therapy (HAART)

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

Chinese prescriptions can inhibit viral replication according to the course of viral replication, and the effects is similar to the effect of HAART, and even better than the anti-viral and immune reconstitution of HAART due to its effect on improve immune system function. Over the past decades, many researchers have screened the effective Chinese medicines to treat AIDS.

NCT ID: NCT00974285 Recruiting - HIV Infections Clinical Trials

Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients

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

The average period of asymptomatic HIV-infection is 8 years, at this stage, CD4+ T lymphocyte count was reduced gradually at the rate of 50~100cells/ul/year. When the CD4 T lymphocyte count dropped below 350cells/ul and viral load increased to 105 in AIDS patients, HAART will be carried out. But, CD4 T lymphocyte was 350~550 cells/ul, there is no intervention measures.