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HIV Infections clinical trials

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NCT ID: NCT00073229 Completed - HIV Infections Clinical Trials

Immune Function of Infants With HIV

Start date: July 2000
Phase: N/A
Study type: Observational

This observational study will evaluate data from infants born to HIV infected mothers in order to better characterize disease progression in early HIV infection.

NCT ID: NCT00073216 Completed - HIV Infections Clinical Trials

Safety of and Immune Response to a Combination HIV Vaccine Regimen in HIV Uninfected Adults

Start date: n/a
Phase: Phase 1
Study type: Interventional

To prevent HIV infection, a vaccine that produces strong HIV-specific humoral (B-cell) and cellular (T-cell) immune system responses is desirable. The purpose of this study is to test the safety of and immune response to a novel combination HIV vaccine in HIV uninfected adults. This study will also test the safety of and immune response to a protein vaccine given alone.

NCT ID: NCT00071890 Completed - HIV Infections Clinical Trials

Phase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Antiretroviral Treatment in HIV-Infected Patients With CD4 T-Lymphocyte Count Greater Than 500 Cells/mm3 Who Received Antiretroviral Tx

ILIADE
Start date: October 2003
Phase: Phase 2
Study type: Interventional

This study will examine whether interleukin-2 (IL-2) given before the interruption of antiretroviral (ARV) treatment could significantly extend the period of time that a patient is temporarily not taking ARV treatment and also preserve CD4 counts above 350 cells per microliter. There will be an evaluation of the toxicity, or extremely harmful effects, of ARV, and the effect on quality of life. The use of ARV medications has greatly improved the condition and mortality of HIV-infected patients. But when used long term, those medications have been associated with great toxicities and medication fatigue. As a result, patients may not adhere to ARV use, and resistance to viruses may grow. The CD4 molecule is on the surface of helper T-lymphocytes, or T-helper cells. It serves as the primary receptor for HIV-1 and HIV-2, allowing the virus to gain entry into its host. The CD4 count increases immediately in response to ARV, giving an estimate of the state of a patient's immune system. Thus, it is a strong marker of the immediate risk of an opportunistic infection, one that takes advantage of a person's weakened immune system. IL-2 is a molecule naturally produced by activated T cells. In patients with HIV, IL-2 treatment can increase CD4 counts but the clinical importance of this increase is not clear. This study will compare the decline in CD4 count, when ARV is interrupted, in two random groups of participants: (1) those who will receive three cycles of IL-2 (one every 8 weeks) in combination with ARV therapy for the first 24 weeks of the study before stopping ARV and (2) those who will receive ARV therapy without IL-2 for 24 weeks before stopping ARV. Patients 18 years of age or older who have HIV-1 infection and who have been on ARV therapy for at least 1 year, and who currently have a CD4 count 500 cells per microliter or higher and never had a CD4 count of less than 200 cells per microliter and a viral load less than the limit of detection, may be eligible for this study. Participants will undergo the following procedures and tests: - Physical examination. - Blood tests to measure blood lipids (fats), sugar, complete blood count including platelets, and chemistries. - Assessment of fat distribution. - Questionnaire about quality of life. In addition, those participants who are randomly placed in the group receiving IL-2 and ARV will get an echocardiogram at the beginning of the study and at week 24. They will receive a starting dose of 6 million units of IL-2 as an injection under the skin twice a day. Each of the three IL-2 cycles will last 5 days. After the 24-week period, participants in both groups will stop taking ARV medications if their CD4 count is still equal to or greater than 500 cells per microliter. The study will continue into 120 weeks. Participants will be asked to continue to visit the clinic every 8 weeks for evaluation of their viral load and CD4 counts. Every 24 weeks, they will be asked to answer a questionnaire about their quality of life. Blood tests and other measurements will also be done as follow-up.

NCT ID: NCT00071851 Completed - HIV Infections Clinical Trials

Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults

Start date: December 2003
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, VRC-HIVDNA009-00-VP, in HIV uninfected participants. Two different doses of the vaccine will be tested.

NCT ID: NCT00071760 Completed - HIV Infections Clinical Trials

Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects

Start date: October 23, 2003
Phase: Phase 2
Study type: Interventional

This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years old.

NCT ID: NCT00071240 Completed - HIV Infections Clinical Trials

Growth Hormone to Increase Immune Function in People With HIV

Start date: October 2002
Phase: Phase 2
Study type: Interventional

Growth hormone plays an important role in the development of the immune system. Studies suggest that growth hormone may promote growth of the thymus, a gland responsible for the production of important immune cells called T cells. Since these cells are lost during the course of HIV infection, it is possible that growth hormone treatment could help restore the immune system. This study will determine whether the administration of growth hormone can increase the size and function of the thymus and cause an increase in the number of new T cells in the blood of people infected with HIV. Study hypothesis: Growth hormone treatment will enhance T cell production in HIV infected adults.

NCT ID: NCT00071097 Completed - HIV Infections Clinical Trials

TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients

Start date: October 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effectiveness, safety, and tolerability (how well the body stands the drug) of an investigational protease inhibitor (PI) called TMC114 given with low dose ritonavir.

NCT ID: NCT00070980 Completed - HIV Infections Clinical Trials

Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV

Start date: March 2003
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether massage therapy can improve immune status and enhance well-being in children living in the Dominican Republic who are infected with HIV.

NCT ID: NCT00069914 Completed - HIV Infections Clinical Trials

Immune Response to Influenza Vaccine in HIV-Infected Individuals

Start date: September 2003
Phase: N/A
Study type: Observational

This study will evaluate how HIV infection, including CD4 cell count and viral load, affects the patient's ability to produce antibodies in response to vaccination with the influenza (flu) vaccine. Earlier studies have shown that people with HIV infection do not respond as well as healthy subjects to flu vaccine; that is, they don't make as many antibodies in response to the vaccine. Before the use of current anti-HIV medications, antibodies made to flu vaccination in HIV-positive individuals was related to their CD4 cell count. This trial will examine how CD4 counts and the amount of virus in the blood affect how much and what kind of antibodies the body makes to the flu vaccine. HIV-infected patients and healthy normal volunteers between 18 and 60 years of age may be eligible for this study. Healthy subjects will serve as controls to make sure the flu vaccine works (i.e., stimulates production of enough antibody to protect against the flu), and to compare the amount of antibodies made by HIV-positive and HIV-negative people. Candidates will be screened with a medical history and blood tests (see below). Women who are able to have children will have a pregnancy test. Pregnant women are excluded from the study. Participants will undergo the following procedures: 1. Blood drawing for the following tests: - Routine tests (complete blood count, kidney and liver functions, electrolyte levels). - CD4 cell count. - HLA typing (a genetic marker of the immune system) if it has not already been done at the NIH. This test may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions. Determining HLA type is necessary to be able to perform certain research studies. Some HLA types have been associated with an increased risk of certain diseases like arthritis and other rheumatologic problems. - Viral load (HIV-infected patients only). - Influenza antibody levels. - B cell levels. 2. Flu vaccination 3. Follow-up visits on days, 7, 28, and 54 after vaccination for the following: - Review of any illnesses or fever. - Review of medications, if any changes were made. - Repeat blood tests.

NCT ID: NCT00069524 Completed - HIV Infections Clinical Trials

Antihyperlipidemic Effects of Oyster Mushrooms

Start date: June 2004
Phase: Phase 1/Phase 2
Study type: Interventional

The primary goal of this study is to evaluate the short-term safety and potential efficacy of oyster mushrooms (Pleurotus ostreatus) for treatment of hyperlipidemia in HIV-infected patients who are taking Kaletra, a protease inhibitor (PI) that is commonly used in highly active antiretroviral therapy (HAART).