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HIV Infections clinical trials

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NCT ID: NCT00798772 Completed - HIV Infection Clinical Trials

Micronutrients and Antioxidants in HIV Infection

MAINTAIN
Start date: January 2009
Phase: N/A
Study type: Interventional

Infection with human immunodeficiency virus (HIV) causes decline in immunity or the ability to fight infection and progresses to acquired immunodeficiency disease (AIDS). Anti-HIV drug treatment has improved the prognosis of persons with HIV infection, but is expensive and potentially toxic. Low micronutrient levels occur in the blood even in early stages of HIV infection and increase risk of a poorer prognosis, but the role of micronutrient and antioxidant supplements in medical management of HIV/AIDS is not well defined. The proposed clinical trial aims to assess if supplementation of untreated HIV-infected adults with a micronutrient and antioxidant preparation can delay decline in immunity or disease progression or start of anti-HIV drug treatment compared with supplementation with standard multivitamins. If the findings are positive, the study has implications for health and health care savings.

NCT ID: NCT00798265 Completed - Clinical trials for Human Immunodeficiency Virus

A Phase I Study of Quadrivalent Human Papilloma Virus (HPV) (Types 6, 11, 16, 18) Recombinant Vaccine in HIV-Infected and HIV-Negative Pre-Adolescents, Adolescents, and Young Adults

Start date: June 29, 2009
Phase: Phase 1
Study type: Interventional

Background: - Human papilloma virus (HPV) is a common sexually transmitted disease. There are more than 100 different HPV types, and both males and females can get HPV infection. Most people do not have any symptoms when they become infected and are able to get rid of the infection on their own. However, they can still become re-infected with the same or a different HPV type, and in some people HPV infection persists. - Persistent HPV infection is associated with the development of precancerous lesions and cancer. HPV types are classified as either high risk or low risk based on whether their persistence will lead to cancer. - Patients who have suppressed immune systems are at a higher risk for HPV-related complications. They are more likely to contract multiple HPV types and have more persistent infection that can lead to precancerous lesions or cancer, which are then difficult to treat and often recur. - A recently approved vaccine for HPV induces immunity to HPV 6, 11, 16, and 18. It was shown to be highly effective in preventing infection with these HPV types, and is approved for use in females 9 to 26 years of age. However, much less is known about the vaccine s ability to induce immunity in males or individuals with suppressed immune systems. Objectives: - To investigate whether the HPV vaccine is safe to give and able to induce immunity in both female and male adolescents and young adults with HIV infection compared to healthy, HIV-negative persons of the same age. Eligibility: - Males and females, 12 to 26 years of age, divided into three groups: (1) Healthy and HIV-negative, (2) HIV-positive and on antiretroviral therapy, and (3) HIV-positive and not on antiretroviral therapy. Design: - Before beginning vaccination, participants will have a complete physical examination and blood drawn for routine blood tests, special tests of the immune system, antibody tests, and an HIV test. - HPV vaccine will be given by injection into the muscle at 0, 2, and 6 months, according to the standard vaccination schedule. - Patients with HIV infection will be monitored for a week following the first injection to test the level of HIV in the blood 3 days and 5 days after the first injection. - Participants will also be asked to fill out a 10- to 15-minute Web-based survey about awareness, health behaviors, and personal choices related to risk factors for HIV, HPV, and other sexually transmitted diseases. Participants are not required to fill out the survey to receive the vaccine. - The total duration of the study is 4 years. During the first year of the study, participants will return for six additional 1-day visits at months 1, 2, 3, 6, 7, and 12. Participants will return for 1-day visits every 6 months for the remaining 3 years.

NCT ID: NCT00795717 Completed - Clinical trials for Cardiovascular Disease

Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial

HALO
Start date: July 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether fish oil supplementation with Lovaza, formally known as Omacor will result in a significant reduction in serum triglyceride (TG), an increase in high density lipoproteins(HDL), and an improvement of endothelial dysfunction.

NCT ID: NCT00795483 Completed - HIV Infections Clinical Trials

Efficacy And Security Of Annual And Biennial Zoledronic Acid For Osteoporosis Treatment In An HIV-Infected Patients' Cohort

Start date: November 2009
Phase: Phase 4
Study type: Interventional

The purpose of this project is to determine the incidence of osteoporosis in the investigators' population of HIV-infected patients and to assess the efficacy and security of zoledronic acid, whose efficacy in post-menopausal women with high fracture risk treatment and in Paget's disease treatment has already been demonstrated.

NCT ID: NCT00792519 Completed - HIV Infections Clinical Trials

Cognitive Behavioral Treatment to Reduce Alcohol Use Among HIV-Infected Kenyans

KHBS
Start date: February 2009
Phase: Phase 1
Study type: Interventional

This study will determine whether a cognitive behavioral intervention that demonstrates strong evidence in the U.S. of reducing alcohol use is effective when delivered by paraprofessionals in Kenya and compared against a usual care support group.

NCT ID: NCT00785616 Completed - HIV Infection Clinical Trials

A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence

Start date: September 2008
Phase: Phase 4
Study type: Interventional

This study will enroll completers of a prior 24 week MEMS cap study of Kaletra adherence, conducted in 2005 - 2006, and repeat the MEMS monitoring for an additional 24 weeks in 2008/2009 on the current antiretroviral anchor drug. The goals of the study are to correlate long-term adherence with virologic outcome, and to explore the stability of MEMS cap adherence measurements over time.

NCT ID: NCT00782808 Completed - HIV Infections Clinical Trials

Peripheral Reservoir of HIV DNA in Monocytes Pivotal to Cognition in HIV

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

Sixty HIV participants will be enrolled and stratified by PBMC HIV DNA levels, either high (greater than or equal to 5000 copies/106 cells) or low (less than 5000 copies/106 cells). Individuals will be enrolled into each group until filled. Screening PBMC HIV DNA levels will be performed at SEARCH in real-time with less than one-week turn around time. All individuals will intend to initiate ARV due to meeting MOPH guidelines for such. The protocol team will work with the primary care physician to facilitate initiation of standard ARV care; however, initiation of ARV is not a requirement of the study and ARV will not be provided by the study.

NCT ID: NCT00782158 Completed - HIV Infections Clinical Trials

Hepatitis B and HIV Co-Infection in Patients in Uganda

Start date: October 27, 2008
Phase:
Study type: Observational

This study will determine the amount of liver scarring (fibrosis) or liver damage in people infected with 1) hepatitis B virus (HBV, a virus that can infect the liver); 2) HIV (the virus that causes AIDS); 3) both HBV and HIV; and 4) neither HBV nor HIV. Liver fibrosis and liver damage can have many causes, including alcohol, certain medicines, exposure to some contaminated foods and infections with viruses that affect the liver (such as HBV). About 25 million people in sub-Saharan Africa are infected with HIV and about 50 million with chronic HBV, yet very little information is available on how many people are infected with both viruses and the medical implications of co-infection. Participants in Uganda s Rakai Health Sciences Program (RHSP) or Infectious Diseases Institute (IDI) clinic who are 18 years of age or older may be eligible for this study. People enrolled in the study come to the clinic for at least one visit and may be asked to return yearly. During the visit, participants undergo the following procedures: - Questionnaire and a short interview about their health and quality of life. - Physical examination and blood draw. The blood is tested for HBV and other factors that may suggest liver disease. Blood drawn at previous clinic visits or from other studies may also be tested. - Liver evaluation using a FibroScan, a medical device that uses elastic waves to measure liver stiffness in a process similar to ultrasound scanning. For this test, the subjects lies flat on the back with the arm extended out. The tip of the machine s probe is covered with gel and placed on the skin between the ribs at the level of the right lobe of the liver. The machine produces a little tap on the skin that sends a wave out and checks how fast the wave moves. The speed of the wave indicates the amount of scarring in the liver.

NCT ID: NCT00777426 Completed - HIV Infections Clinical Trials

HIV-1 Specific Immune Responses in Thai Individuals With HIV Dementia

Start date: September 2008
Phase: N/A
Study type: Observational

A total of 60 participants will be enrolled. They will be in 3 groups 1. ARV-naïve, HIV-positive ≥ 20 year of age with HAD (n=25) who intend to start ARV 2. ARV-naïve, HIV-positive ≥ 20 year of age without HAD (n=25), who intend to start ARV 3. HIV-negative ≥ 20 year of age (n=10). The protocol team will work with the primary care physician to ensure that the subjects receive standard HIV and ARV care; however, initiation of ARV is not a requirement of the study and ARV will not be provided by the study. Participant accrual will include 10-15 participants per year. HIV-positive subjects will be tentatively enrolled in HAD vs. non-HAD groups by the enrolling neurologist and subsequently confirmed to that group by a consensus conference held every 6 months by the study neurologists. In cases of disagreement, cases will be re-assigned to the consensus conference determination and recruitment will continue. An external validation consensus conference will be conducted as well every 6-12 months to monitor correct assignment of the level of impairment.

NCT ID: NCT00775424 Completed - HIV Infection Clinical Trials

PENNVAX-B With or Without IL-12 or IL-15 as a DNA Vaccine for HIV Infection

Start date: September 2008
Phase: Phase 1
Study type: Interventional

A phase Ib partially blinded pilot study to evaluate the safety and immunological effects of PENNVAX-B with or without co-administration of constructs containing DNA encoding for the expression of either IL-12 or IL-15. Primary objectives 1. To determine the safety of HIV-1 DNA constructs (PENNVAX-B). 2. To determine the safety and optimal doses of the IL-12 and the IL-15 adjuvant constructs when given with PENNVAX-B. Secondary objectives 1. To compare the various vaccine groups for their immunological responses to several HIV-1 antigens, utilizing the ELISPOT assay. 2. To analyze antibody responses to the vaccine antigens over time. 3. To measure CD8 cell proliferative responses to vaccine antigens over time.