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HIV Infections clinical trials

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NCT ID: NCT00102960 Completed - HIV Infections Clinical Trials

Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth

Start date: July 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effects of anti-HIV drug courses of different lengths in infants who became HIV infected at birth.

NCT ID: NCT00102934 Active, not recruiting - HIV Infections Clinical Trials

Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus

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

Drug resistance may develop in HIV infected patients who take anti-HIV drugs, but most patients do well if they continue taking them. The purpose of this study is to test the effectiveness of a short, intensified course of anti-HIV drugs for controlling HIV infection in adults who have virus resistant to multiple drugs.

NCT ID: NCT00102908 Unknown status - HIV Infections Clinical Trials

Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density

Start date: May 2005
Phase: Phase 2
Study type: Interventional

Bisphosphonates are a type of drug used to prevent and treat bone loss. The purpose of this study is to determine if zoledronate, an investigational bisphosphonate, can improve bone mineral density (BMD) in HIV-infected adults. Study hypothesis: Zoledronate will reduce bone resorption in HIV-infected persons with osteopenia.

NCT ID: NCT00102778 Terminated - HIV Infection Clinical Trials

GW873140 In Combination With Kaletra In HIV Infected Subjects

Start date: December 2004
Phase: Phase 2
Study type: Interventional

This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Kaletra in HIV infected, untreated subjects.

NCT ID: NCT00102206 Completed - HIV Infections Clinical Trials

A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy

Start date: n/a
Phase: Phase 2
Study type: Interventional

HIV infected children and adolescents who have taken many anti-HIV drugs may have limited treatment options and are at high risk for progressing to AIDS. The purpose of this study is to determine whether an anti-HIV treatment regimen of 2 protease inhibitors (PIs) and 2 nucleoside reverse transcriptase inhibitors (NRTIs) is more effective than a regimen of 4 NRTIs in treatment-experienced children and adolescents who have failed previous anti-HIV treatment.

NCT ID: NCT00102089 Completed - Healthy Clinical Trials

HIV-1 Vaccine Booster in Previously Immunized Uninfected Adult Volunteers

Start date: January 18, 2005
Phase: Phase 1
Study type: Interventional

This study will test the safety and side effects of an experimental vaccine booster against HIV. A vaccine is a substance given to try to create immunity or resistance to a disease or infection. The vaccine used in this study is called VRC-HIVADV014-00-VP. It is made from an adenovirus (a common virus that causes upper respiratory infections) that contains DNA (genetic material) of three HIV proteins. Injected into a human, the viral DNA instructs the body to make small amounts of some HIV proteins. VRC-HIVADV014-00-VP will be given to people who previously received a vaccine called VRC-HIVDNA009-00-VP under NIH protocol 03-I-0022. Important: Study participants cannot catch an adenovirus infection or HIV or AIDS from the vaccine or any proteins made from it. Healthy normal volunteers who participated in NIH protocol 03-I-0022 may be eligible for this study. They must have completed three injections of 4 mg or 8 mg of VRC-HIVDNA009-00-VP without experiencing a serious side effect that was possibly related to the vaccine. Candidates are screened with a medical history, clinical evaluation, blood and urine tests, and HIV and pregnancy counseling. Participants receive one injection of VRC-HIVADV014-00-VP the day they enroll in the study (study day 0). They are observed for at least 30 minutes after immunization. At home, they record their temperature and any symptoms they may experience, including any effects at the injection site, for 5 days and call a study nurse 1 or 2 days after the injection. They immediately report any symptoms to the clinic staff and, if necessary, come to the clinic for an examination. Participants have five additional clinic visits during the study, at weeks 2, 4, 6, 12 and 24, each lasting about 2 hours. At each visit, they are checked for health changes or problems and are asked about medications they are taking. Blood is drawn for immune function testing, HLA typing (a genetic test of immune system markers), and other genetic factors. A urine sample is collected at some visits. Additional laboratory tests may be requested between visits. Some participants may undergo apheresis at the week 4 visit to collect a large number of white blood cells for laboratory tests to see how the immune system responds to the study vaccine. For this procedure, blood is collected through a needle in an arm vein and flows through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The white cells are extracted and the rest of the blood is returned through another needle in the other arm. The procedure takes about 1 to 3 hours. Participants are tested three or more times for HIV and are questioned about their sexual behavior and drug use. They complete a "social impact" questionnaire at week 24 that includes questions about any problems they may have experienced from their participation in the study regarding such things as insurance, health care, friends, family, employment, housing, education, or government agencies.

NCT ID: NCT00101374 Completed - HIV Infections Clinical Trials

Effect of Leflunomide on T Cell Proliferation in HIV-Infected Patients

Start date: January 5, 2005
Phase: Phase 1
Study type: Interventional

This study will evaluate the effect of leflunomide on the life cycle of a specific immune cell called CD4+ T cell in HIV-infected patients. Leflunomide is approved by the Food and Drug Administration for treating rheumatoid arthritis. It works by blocking cell division in activated T cells. In HIV infection, the HIV virus causes increased activation of T cells. The activated cells become infected and die. Activation may also cause the death of T cells that are not infected with HIV. T cells are necessary for the body to fight infections and cancer. This study will see if leflunomide can block T-cell division and possibly reduce the number of cells that die, reduce the number of cells in which HIV can reproduce, and lead to a lower level of HIV virus in the body. HIV-infected patients between 18 and 65 years of age who have 1) HIV viral levels of 1,000 copies/mL or more, 2) a CD4+ T-cell count of 350 cells/mm3 or more, and 3) a CD4+ T-cell count that has never been less than 200 cells/mm3 may be eligible for this study. Candidates are screened with a medical history, physical examination, blood and urine tests, chest x-ray, and electrocardiogram (EKG). Participants are randomly assigned to take leflunomide or placebo (a substance with no active ingredient) every day for 28 days. They come to the clinic three times during the first 29 days of the study (days 1, 15, and 29) for a physical examination and review of any drug side effects. Patients taking placebo end their participation on day 29. Patients taking leflunomide stop taking the drug on day 29 and begin taking cholestyramine three times a day for 11 days out of the next 14 days to clear the leflunomide from their body. On day 43, they return to the clinic to have their leflunomide level checked to make sure that only very little or none of the drug remains in the body. If the level is low, patients end their participation on or around day 57. If the level remains high, they repeat the cholestyramine treatment.

NCT ID: NCT00100984 Terminated - HIV Infection Clinical Trials

A 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir + Lopinavir/Ritonavir + Other Nucleoside Combinations to See the Efficacy of These Treatments in Patients Infected With HIV-1

Start date: July 21, 2004
Phase: Phase 4
Study type: Interventional

The main objective of this study is to compare the safety and efficacy of an enfuvirtide containing regimen to a nucleoside combination regimen. Resistance information will also be collected.

NCT ID: NCT00100867 Completed - HIV Infections Clinical Trials

Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women

Start date: June 2006
Phase: N/A
Study type: Observational

In clinical trials being conducted throughout the world, pregnant HIV-infected women are given anti-HIV drugs before, during, and after they give birth to prevent mother-to-child transmission of HIV. However, the effects of this anti-HIV treatment on infants is unknown. The purpose of this study is to determine the safety, toxicity, and potential side effects of maternal anti-HIV treatment on infants born to these HIV-infected women. Study hypothesis: Specific combination antiretroviral regimens used in clinical trials in diverse areas of the world are safe and well tolerated during pregnancy and breastfeeding periods, and are not associated with adverse side effects to the fetus, neonate, and/or breastfeeding infant. These regimens are associated with reduction of mother-to-child HIV transmission.

NCT ID: NCT00100698 Completed - HIV Infections Clinical Trials

Physiologic Growth Hormone Effects in HIV Lipodystrophy

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

This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will include measures of insulin-like growth factor-1 (IGF-1), glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters.