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HIV Infections clinical trials

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NCT ID: NCT00074412 Completed - HIV Infections Clinical Trials

Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding

Start date: January 2007
Phase: Phase 3
Study type: Interventional

The many benefits of breastfeeding are well documented. However, because of the risk of mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there is considerable concern over the practice, especially in developing countries. The purpose of this study is to determine the safety and effectiveness of the anti-HIV drug nevirapine (NVP) in preventing MTCT of HIV in breastfeeding infants born to HIV infected women in South Africa, Tanzania, Uganda, and Zimbabwe.

NCT ID: NCT00074399 Completed - HIV Infections Clinical Trials

Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV

Start date: February 2001
Phase: Phase 3
Study type: Interventional

HIV can be transmitted from an HIV infected mother to her infant through her breast milk. The purpose of this study is to determine whether giving infants of HIV infected mothers the anti-HIV drug nevirapine (NVP) for six weeks will reduce the risk of HIV transmission. Study hypothesis: Six weeks of nevirapine prophylaxis provided to the infant will decrease HIV transmission through breastfeeding.

NCT ID: NCT00074386 Completed - HIV Infections Clinical Trials

Kidney and Liver Transplantation in People With HIV

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

With improved anti-HIV drug therapy, HIV infected patients are now living longer. These patients are at risk for liver and kidney failure and may need organ transplants. However, little is know about the safety and effectiveness of organ transplants in patients with HIV. This study will evaluate organ transplantation in HIV infected patients undergoing liver and kidney transplants.

NCT ID: NCT00073424 Completed - HIV Infections Clinical Trials

Factors Affecting Adherence to Anti-HIV Drug Regimens in Children and Adolescents

Start date: January 2004
Phase: N/A
Study type: Observational

Taking anti-HIV medication consistently and properly is a critical issue for patients with HIV. Drug regimens are complex; when regimens are not taken properly, HIV can become resistant to the drugs. Taking anti-HIV medication properly leads to improved health. Children and adolescents with HIV face unique challenges to taking HIV medication properly. This study will look at the relationship between how children cope with the responsibility for taking medication and the child's language, memory, attention, behavior, and academic skills. This study is open to children and adolescents who are currently enrolled in the PACTG 219C study (Long-Term Effects of HIV Exposure and Infection in Children).

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: NCT00071500 Active, not recruiting - HIV Infections Clinical Trials

An Electronic Pillbox for People With HIV

Start date: October 2003
Phase: Phase 1
Study type: Interventional

Anti-HIV drug regimens can be very complicated. This study will evaluate a new electronic pillbox designed to help people take their anti-HIV drugs correctly.