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HIV Infections clinical trials

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NCT ID: NCT00789009 Recruiting - HIV Clinical Trials

Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection

Start date: November 20, 2008
Phase:
Study type: Observational

This study will investigate HIV infection and associated conditions by monitoring infected patients. The study will also serve as a means for recruiting HIV-infected individuals to NIAIDs ongoing clinical and laboratory studies and supporting the institute s infectious disease training program by providing Infectious Disease fellows with ongoing training in the management of HIV infection. People 18 years of age and older with suspected or confirmed HIV infection who live in the Washington, D.C., metropolitan area may be eligible for this study. Physician referral is required. Participants come to the NIH Clinical Center a minimum of once every 3 to 4 months for evaluation with a physical examination; blood tests for research purposes, safety, immune status and viral load; and response to any treatment they may be receiving. Other procedures, such as a biopsy, are done only as needed for standard medical practice, and informed consent is obtained before any such procedure is done. Treatment offered is consistent with standard medical practice; no experimental treatments are offered under this protocol. ...

NCT ID: NCT00785967 Withdrawn - HIV Infections Clinical Trials

Immune Responses in Patients Treated With Raltegravir

RAG-1/2
Start date: January 2009
Phase: Phase 3
Study type: Interventional

Hypothesis: Treatment with raltegravir does not alter V(D)J recombination or immune responses to neoantigens. A process known as V(D)J recombination is essential for developing lymphocytes and the specific functioning of the immune system. Raltegravir is the first approved drug of the new integrase inhibitor class of anti-HIV drugs. Integrase inhibitors have been shown in some studies to interfere with DNA cleavage and the activities of RAG-1/2. These studies suggest a potential to affect aspects of both B-cell and T-cell development, therefore, it is important to evaluate the potential effects that integrase inhibitors may have in clinical use. If immunoglobulin and T-cell receptor genes are altered by HIV integrase, then patient lymphocytes will fail to display normal responses to vaccinations.

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: NCT00783614 Terminated - HIV Infection Clinical Trials

Aspirin and Antiretroviral Therapy in HIV Infected Patients

Start date: October 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine the effects of HIV treatment (antiretroviral therapy) and aspirin use on risk for cardiovascular disease among HIV infected persons.

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: NCT00782301 Withdrawn - Hepatitis B Clinical Trials

Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients

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

Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.

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: NCT00781287 Terminated - Clinical trials for Human Immunodeficiency Virus

Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1

UW PIC 330
Start date: February 2009
Phase: Phase 4
Study type: Interventional

This is an investigator-initiated, two-year, randomized, controlled, single-center, open-label, pilot study comparing 3-drug highly active antiretroviral therapy (HAART) to 3-drug HAART plus raltegravir for persons with acute and early HIV-1 infection. The study will test the hypothesis that use of the integrase inhibitor raltegravir (400 mg BID orally) to inhibit the integration step of the HIV-1 life cycle in conjunction with HAART in subjects with recently acquired HIV-1 infection will decrease the number of HIV-1 infected CD4+ T-cells to a greater extent than a 3-drug HAART regimen.

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: NCT00775606 Terminated - Clinical trials for Acquired Immune Deficiency Syndrome

Immune Reconstitution of Lopinavir/Ritonavir-Based vs Efavirenz-based HAART in Advanced HIV Disease

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

The ideal anti-HIV medications for patients with advanced HIV disease is unknown. There is evidence that anti-HIV regimens that contain protease inhibitors can enhance immune function better than regimens that do not contain protease inhibitors. This is a study that will determine the difference in immune enhancement capabilities between an anti-HIV regimen that contains the protease inhibitor - lopinavir-ritonavir, and a regimen that contains efavirenz. Both medications are recommended as first line treatments for HIV-infected patients. This study will recruit HIV-positive patients that need to start anti-HIV treatment because their CD4+ T-cells are below 200. The usual threshold for starting treatment is a CD4+ T-cell less than 350. Subjects will be randomized to treatment with either an anti-HIV regimen that contains lopinavir-ritonavir or a regimen that contains efavirenz. The study will determine the difference in immune reconstitution over 24 weeks of treatment with study medications. Among the immune parameters that will be measured is the ability of each subject to respond to vaccination with the tetanus-diphtheria vaccine and the 23-valent pneumococcal vaccine. Both vaccines are also recommended for HIV-positive patients but HIV-positive patients tend to have a lower response rate to these vaccines.