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HIV Infections clinical trials

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NCT ID: NCT00051818 Completed - HIV Infections Clinical Trials

Immune and Viral Outcomes of HIV-1 Therapy Interruption

Start date: September 2000
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if stopping anti-HIV drugs for a period of time is safe and effective for enhancing the immune function of patients with HIV.

NCT ID: NCT00051805 Completed - HIV Infections Clinical Trials

Promoting Adherence to Anti-HIV Drug Regimens

Start date: August 2002
Phase: N/A
Study type: Interventional

One of the main causes of treatment failure in HIV infected individuals is lack of adherence to complicated drug regimens. The purpose of this study is to evaluate the effectiveness of a behavioral intervention program designed to improve adherence to anti-HIV drug regimens. Participants in this study will be recruited from the University of Alabama at Birmingham (UAB) Outpatient HIV Clinic.

NCT ID: NCT00051519 Completed - HIV Infection Clinical Trials

Screening HIV-Infected Patients for Vaccine Studies

Start date: January 9, 2003
Phase: N/A
Study type: Observational

This screening study will evaluate potential study volunteers with HIV infection to see if they are suitable candidates for trials of experimental vaccines against HIV (therapeutic), and against other infections (preventive). - Preventive vaccines against other infections. Preventive vaccines prevent a person from getting a disease. Preventive vaccines have been developed for many diseases, including, for example, whooping cough, measles, mumps, influenza, and hepatitis B. Some preventive vaccines may also prevent a disease from taking hold if given immediately after infection, such as vaccines for rabies, smallpox and hepatitis. - Therapeutic vaccines against HIV. Therapeutic vaccines are intended to treat someone who has already been infected, with the goal of controlling the disease or preventing it from causing severe illness. As yet, there are no therapeutic vaccines for any diseases. - Vaccines against other infections. Vaccines to prevent other infections besides HIV may need to be tested separately in people with HIV infection because the immune system works differently when HIV infection is present. HIV-infected patients 18 years of age or older may be eligible for this screening study. Women who are pregnant or breast feeding may not participate. Participants will be screened with the following: - A health history, including questions about sexual activity and drug use; - Physical examination, including blood and urine tests; - HIV testing to confirm HIV infection; - Pregnancy test for premenopausal women; - PPD test for tuberculosis for those who have not been tested in the previous 6 months. Candidates who meet the requirements for investigational vaccine studies will be invited to participate in a study. Those who do not begin a study within 1 month of the screening tests may need to repeat some tests for continued consideration. In addition, some studies require repeated measures of CD4 counts and viral load over a period of a few months.

NCT ID: NCT00051454 Completed - HIV Infections Clinical Trials

Evaluation of the Safety of and Immune Response to an HIV Vaccine in Healthy Adults

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

This study will examine the safety and immune response to a two-part HIV vaccine. Healthy volunteers who are at low risk of HIV infection will receive either active vaccine or a placebo.

NCT ID: NCT00050921 Completed - HIV Infections Clinical Trials

Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs

Start date: n/a
Phase: N/A
Study type: Interventional

This study is designed to evaluate the ability of growth hormone (GH, also known as somatropin) to increase CD4+ cell counts in patients taking anti-HIV drugs. The study is targeted toward patients with low levels of HIV who continue to have low CD4+ cell counts.

NCT ID: NCT00050908 Completed - HIV Infections Clinical Trials

Blood Vessel Function in HIV-Infected Patients Taking Anti-HIV Drugs

Start date: n/a
Phase: N/A
Study type: Observational

This is a substudy of ACTG A5142. The purpose of this substudy is to evaluate blood vessel function in HIV-infected patients taking anti-HIV drugs.

NCT ID: NCT00050895 Completed - HIV Infections Clinical Trials

Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients

Start date: n/a
Phase: Phase 3
Study type: Interventional

With new strategies and drugs available, many different regimens exist for the treatment of HIV. The purpose of this study is to compare three different anti-HIV drug regimens as first-time treatments for HIV infection.

NCT ID: NCT00050856 Completed - HIV Infections Clinical Trials

Fuzeon (Enfuvirtide) Early Access Program for Patients With HIV-1 Infection

Start date: November 2002
Phase: Phase 3
Study type: Interventional

This study will determine the safety and tolerability of Fuzeon (enfuvirtide) used together with other treatments for HIV infection in patients with advanced HIV disease. Fuzeon is an antiretroviral drug. Unlike other antiretrovirals, however, which work against the virus once it is already in the cell, Fuzeon prevents the virus from getting into healthy cells. Patients 18 years of age and older with advanced HIV-1 infection, who do not respond to approved antiretroviral therapy, may be eligible for this study. Candidates must have a CD4 lymphocyte count less than 100 cells/mm3 and a viral load greater than 10,000 copies/mL. They will be screened with a medical history, physical examination, and blood tests, and may also have an electrocardiogram (ECG), chest x-ray and urine test. Patients enrolled in the study will be re-examined and have additional blood tests before beginning treatment with Fuzeon. They will then be taught how to self-inject the medicine under the skin and will take two doses daily (less than 1/4 teaspoon each), 12 hours apart. After the first treatment, participants will have follow-up visits at weeks 1, 2, 4, 8, 12, 24, 36, 48, and every 12 weeks after that, if necessary, until 12 weeks after the drug becomes commercially available. Visits may be scheduled more often if a problem arises. During the follow-up visits, patients will have blood drawn, and their blood pressure, pulse rate and temperature will be checked. They will also report any drug side effects they have experienced. Patients may continue to take Fuzeon as long as they benefit from therapy and do not experience severe side effects from the treatment. The drug will be provided to participants until 12 weeks after it is sold in the United States.

NCT ID: NCT00050726 Completed - HIV Infections Clinical Trials

Studies of Influenza Vaccine and Tetanus-Pneumococcal Vaccine in HIV-infected Patients Receiving Interleukin-2

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

This investigation is a sub-study of the 6-year multinational ESPRIT (Evaluation of Subcutaneous Proleukin in a Randomized International Trial) protocol. It will compare the effectiveness of the influenza (FLUVAC) and tetanus-pneumococcal (TEPVAC) vaccines in HIV-infected patients receiving interleukin-2 (IL-2) plus anti-HIV drugs with those receiving only anti-HIV drugs. IL-2 is a protein naturally produced by immune cells called lymphocytes. Lymphocytes from patients with HIV do not produce IL-2 normally. The ESPRIT trial is evaluating whether HIV-infected patients treated with antiretroviral drugs plus IL-2 have fewer serious infections and improved survival than those receiving only anti-HIV drugs. Participants in this sub-study will be drawn from patients enrolled in ESPRIT. They must be 18 years of age or older, have HIV infection with no symptoms of significant HIV illness. They will be vaccinated against either influenza or tetanus and pneumococcus, as follows: FLUVAC Potentially eligible patients will be screened for the FLUVAC study during an ESPRIT follow-up visit. Those who are eligible and agree to participate will have 10 ml (1 tablespoon) of blood drawn to assess baseline antibody levels and then receive the vaccination. They will be vaccinated annually for 3 years. A blood sample (10 ml) will be drawn 1 month after each vaccination to measure the immune response. Some of the blood drawn for this study will be stored and used for research purposes. TEPVAC Participants will have 10 ml of blood drawn to assess their baseline antibody levels. They will receive two vaccinations (tetanus and pneumococcus) 12 months after enrolling in ESPRIT and another two vaccinations 24 months after enrollment. A blood sample (10 ml) will be drawn 1 month after each vaccination to measure the immune response. Some of the blood drawn for this study will be stored and used for research purposes.

NCT ID: NCT00050284 Completed - HIV Infections Clinical Trials

Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection

Start date: n/a
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether patients who have asymptomatic HIV infection can discontinue antiretroviral therapy (ART) without adverse clinical, virologic, or immunologic consequences. This study will also assess the virologic, immunologic, and clinical outcomes in any patients who restart ART.