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HIV Infections clinical trials

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NCT ID: NCT00011037 Completed - HIV Infections Clinical Trials

ALVAC-HIV vCP1452 Alone and Combined With MN rgp120

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

The purpose of this study is to test how the body's immune system responds to the vaccine ALVAC-HIV vCP1452 and to determine if the vaccine is safe when given alone and with MN rgp120. HIV infection and AIDS have no cure, in spite of recent advances in anti-HIV drugs. Many worldwide populations cannot afford the antiviral treatments for infected people. HIV vaccines offer hope for disease prevention. In this trial, 2 experimental HIV vaccines called ALVAC vCP1452 and MN rgp120 will be given to volunteers in Haiti, Brazil, Peru, and Trinidad and Tobago. The study will determine how volunteers' immune systems respond to the vaccines. (This protocol has been changed by adding new international sites.)

NCT ID: NCT00011011 Completed - HIV Infections Clinical Trials

Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients With HIV

Start date: February 2001
Phase: Phase 1/Phase 2
Study type: Interventional

Long-term control of HIV depends on improvement in an individual's immune system. The purpose of this study is to see if either stopping anti-HIV drugs for short periods of time and/or adding a vaccine to the anti-HIV drugs being taken will help to better control HIV infection. The study will test whether these treatment approaches are safe. The HIV vaccine in this study has been tested in people who did not have HIV infection and improved the way their immune system worked. This study will evaluate whether these same immune system changes happen in people with HIV, and, if such changes do occur, assess whether these changes help to improve control of HIV in these patients.

NCT ID: NCT00010491 Completed - HIV Infections Clinical Trials

Acupuncture and Moxa: A Randomized Clinical Trial for Chronic Diarrhea in HIV Patients

Start date: September 1999
Phase: Phase 2
Study type: Interventional

The objective of this study is to test alternative treatment strategies to reduce the frequency of chronic diarrhea among HIV positive individuals. 60 percent of patients with HIV disease in the U.S. will have diarrhea at some point in their illness. Although in general many of the opportunistic infections (OI's) associated with HIV have decreased due to new "drug cocktails", many of these drugs, however, have diarrhea as a side effect. In Asian countries, acupuncture (including moxibustion) has been widely used for the treatment of various gastrointestinal (GI) disorders. However, there are no published studies that test treatment protocols using acupuncture or moxibustion on patients with HIV experiencing chronic diarrhea.

NCT ID: NCT00010348 Recruiting - HIV Infections Clinical Trials

Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1

Start date: November 2000
Phase: Phase 2
Study type: Interventional

OBJECTIVES: I. Determine the safety of total body irradiation and post-transplant cyclosporine and mycophenolate mofetil in high-risk patients with human immunodeficiency virus-1. II. Determine whether this regimen results in stable mixed donor lymphocyte chimerism (5-95% donor CD3) in this patient population. III. Determine the kinetics of immune reconstruction following this treatment regimen in this patient population. IV. Determine the effect of this treatment regimen on viral load in this patient population.

NCT ID: NCT00009555 Completed - HIV Infections Clinical Trials

Testosterone for HIV-Positive Men With Reduced Serum Testosterone Levels and Abdominal Fat

Start date: n/a
Phase: Phase 4
Study type: Interventional

The purpose of this study is to see if treatment with testosterone will reduce abdominal fat in HIV-positive men. Many HIV patients on antiretroviral therapy show an increase in abdominal fat. Studies have shown that treatment with testosterone may decrease abdominal fat. This study will determine if testosterone will reduce abdominal fat in HIV patients.

NCT ID: NCT00009256 Completed - HIV Infection Clinical Trials

Analysis of HIV Genetic Variation in Patients Before Beginning Highly Active Antiretroviral Therapy

Start date: April 13, 2000
Phase: N/A
Study type: Observational

The purpose of this study is to gain knowledge about why drug therapy sometimes stops working in people infected with the human immunodeficiency virus (HIV). This occurs in 30 to 40% of patients treated with powerful antiretroviral drugs. The study will examine how the virus becomes resistant to drug treatment through mutations (changes) and how different mutations produce new variants that are resistant to more than one drug. HIV-infected patients 18 years and older who have not been treated with antiretroviral medications and who have a relatively stable amount of virus in their blood (viral load) may be eligible for this study. Pregnant or breastfeeding women may not participate. Candidates will be screened with blood tests to determine viral load and to study the genetics of the virus. Participants will be hospitalized at the NIH Clinical Center for 10 days for daily blood sampling. (In exceptional circumstances, the sampling may be done on an outpatient basis.) After discharge, patients will be followed by weekly visits for blood tests for a total of 120 days. When antiretroviral treatment begins, the patient may do one of the following: 1. Continue on this study with antiretroviral treatment. Therapy will consist of D4T, 3TC, and efavirenz. Other drugs may be substituted for any of these that cannot be tolerated. HIV protease inhibitors will not be included in the regimen. 2. Complete participation in this study and, if eligible, enroll in another NIH protocol (AVBIO). 3. Begin standard antiretroviral therapy with a private physician. Patients for whom treatment is not yet recommended or who choose not to be treated may continue to be monitored with blood tests for a total of 18 months. (Patients who leave the study after this time may re-join when they decide to start treatment.) Participants may also undergo the following optional procedures to study the genetic variation of HIV: lymph node biopsy, spinal tap, and semen donation or female genital washing to collect secretion samples. Sexual partners or needle-sharing partners of study patients are invited to enroll in this study to provide blood samples at the time the patient enrolls and at two intervals after any needle sharing or unsafe sex event they may report to NIH. Partners may also donate genital secretions or semen, and a lymph node or spinal fluid sample. Information from this study may help in the development of new drug treatments that will be effective in controlling HIV infection when other treatments no longer work.

NCT ID: NCT00009061 Active, not recruiting - HIV Infections Clinical Trials

Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs

Start date: November 2000
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.

NCT ID: NCT00009009 Completed - HIV Infection Clinical Trials

Kidney Transplant for HIV-Infected Patients in Renal Failure

Start date: January 2001
Phase: Phase 2
Study type: Interventional

This study will examine the safety and effectiveness of renal (kidney) transplantation for HIV-infected patients with end-stage renal disease (kidney failure). Although kidney transplant is the best treatment for most causes of kidney failure, people infected with HIV are not offered this procedure because the immunosuppressive drugs (drugs that suppress immune function) required to prevent organ rejection could further impair the patient's already weakened immune system. This study will use a regimen of immunosuppressants designed to complement treatment for patients taking highly active antiretroviral therapy (HAART). HIV-infected patients between 18 and 60 years of age with renal failure who have not had any opportunistic infections for 5 years may be eligible for this study. Candidates will be screened with a medical history, physical examination, and blood and urine tests. Before the transplant procedure, participants will undergo additional tests and procedures, including blood studies, 24-hour urine collection, infectious disease consultation, tuberculin skin test, PAP smear for women, chest X-ray, brain and hip MRI studies and DEXA-scan to evaluate bone density. In addition, patients may undergo leukapheresis to obtain white blood cells for study. For this procedure, whole blood is drawn through a needle in an arm vein and passed through a cell separator machine. The white cells are collected for removal, and the rest of the blood is returned to the body through the same needle or another needle in the other arm. When a donor organ becomes available for transplant, the patient will receive three anti-rejection drugs-cyclosporine, mycophenolate mofetil and prednisone-to prevent organ rejection. Immediately after the surgery, HAART drugs will be stopped for 7 days until stable levels of the immune suppressants can be achieved. Then, HAART will be re-started and all medications will be adjusted to achieve adequate blood levels. Patients must stay in the local area 60 days after discharge from the hospital for monitoring. Frequent blood samples will be taken to monitor kidney function, viral load and CD4+ T cell counts. Follow-up visits will then be scheduled monthly for the first 6 months after transplant, then every other month for 1 year. Kidney biopsies will be done at the end of the first month, after 6 months, and yearly for 5 years. For the biopsy, a special needle is used to remove a small piece of kidney tissue for microscopic examination. The biopsies and blood tests are done to evaluate the immune response to the transplanted organ and to study how HAART interacts with the immune suppressing drugs.

NCT ID: NCT00008866 Withdrawn - HIV Infections Clinical Trials

Effectiveness of Early or Delayed Addition of Hydroxyurea to a Three-Drug Anti-HIV Drug Combination Including Didanosine, in Advanced HIV Patients Who Failed a First or Second Anti-HIV Triple-Drug Therapy

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

The purpose of this study is to find out whether or not the addition of hydroxyurea to didanosine (ddI) and other anti-HIV medications will result in better control of HIV infection. The Food and Drug Administration (FDA) has approved ddI for treating HIV infections. Hydroxyurea is approved for treating some cancers and blood disorders. It works against HIV-1 when combined with ddI. Researchers need to look at how well patients may respond to hydroxyurea in combination with ddI and other anti-HIV drugs, and at any side effects.

NCT ID: NCT00008554 Active, not recruiting - HIV Infections Clinical Trials

Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy

Start date: November 2000
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.