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HIV Infections clinical trials

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NCT ID: NCT00006494 Completed - HIV Infection Clinical Trials

Study of Tests to Evaluate Effectiveness of Anti-HIV Drugs

Start date: November 7, 2000
Phase: N/A
Study type: Observational

The purpose of this study is to determine how laboratory tests called genotyping and phenotyping assess the effectiveness of antiretroviral drugs used to treat HIV infection. Some HIV-infected patients have measurable levels of virus in their blood even though they are taking combination drug therapy-including didanosine, stavudine, or efavirenz-against HIV. Genotyping and phenotyping can be used to test for resistance to a specific drug, thereby providing information that can help doctors decide on optimal drug treatment for a given patient. Genotyping identifies mutations, or changes, the virus undergoes that allow it to continue to grow despite drug treatment. Phenotyping involves growing the virus in test tubes with different amounts of drug and then calculating how much drug is required to stop its growth. Patients 18 years of age and older with HIV infection and viral levels between 5000 and 100,000 copies per milliliter of blood who have been taking antiretroviral therapy for at least 6 months may be eligible for this study. Candidates will be screened with a urine test and various blood tests, including genotyping and phenotyping. Participants will have a series of tests to determine whether or not a drug is active against HIV. This involves temporarily stopping the drug under study (i.e., either efavirenz or didanosine or stavudine). The study procedure is as follows: 1. Patients will have six blood tests over 10 days to measure viral load while on all current anti-HIV medications. On one of those days two blood tests will be done to measure levels of didanosine or stavudine. Efavirenz will also be measured if this drug is to be stopped. 2. The patient will temporarily stop the drug under while continuing to take the other drugs. (Efavirenz will be stopped for 3 weeks; stavudine and didanosine will be stopped for 2 weeks.) Seven blood tests will be done at the following intervals to measure viral load: For patients who stop efavirenz, blood will be drawn on days 13, 18, 20, 22, 24,28 and 30. (Day 0 is the first day of the study.) Patients who stop stavudine or didanosine will have blood drawn on days 11, 13, 15, 17, 19, 22 and 24. Repeat genotype and phenotype testing will also be done during this time, and a CD4 count (measurement of a certain type of white blood cell) will be done at the end of this 2- or 3-week period. 3. The drug that was stopped will be restarted and viral load tests will be repeated. For pati...

NCT ID: NCT00006493 Completed - HIV Infections Clinical Trials

Rosiglitazone in the Treatment of HIV-Associated Hyperlipidemia

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

The purpose of this research is to study the effects of rosiglitazone, a drug usually taken for Type II diabetes, on HIV-associated hyperlipidemia. HIV-associated lipodystrophy is a medical condition characterized by gradual changes in the distribution of body fat. The body fat located in the extremities and face disappears while body fat around the abdomen and upper back increases. Certain biochemical changes occur in association with these changes in fat distribution. Lipid levels particularly serum triglycerides are increased. HDL, the "good cholesterol" is decreased. Higher than normal level of insulin or insulin resistance is also found in this condition. This latter condition is one of the hallmarks of Type II diabetes. The protease inhibitors, a class of HIV medications, are associated with the occurrence of HIV-associated lipodystrophy. It has been suggested that a biochemical pathway known as the peripheral peroxisomal activating receptor (PPAR) gamma system is blocked leading to the onset of this condition. Rosiglitazone is a new drug approved by the FDA in 1999 for the treatment of type II diabetes. It lowers blood sugar by improving insulin resistance, which as mentioned before, is the hallmark of Type II diabetes. It has also been noted to improve blood lipid levels. Rosiglitazone works by stimulating the PPAR gamma system. It is hoped that this drug can turn on the PPAR system and reverse the HIV-associated lipodystrophy syndrome.

NCT ID: NCT00006490 Completed - HIV Infections Clinical Trials

A Comparison of Two Tests for Anti-HIV Drug Resistance

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

The purpose of this study is to compare 2 different types of tests of the HIV virus to see which specific anti-HIV drugs would work the best. Drug resistance is a major reason for therapy failure in HIV patients. Two types of tests can detect resistance to drugs: 1) genotyping (sequencing), which looks at the DNA sequence of a virus to see whether it has developed any genetic resistance; 2) phenotyping, which looks at the ability of different drugs to suppress virus growth in the laboratory. Genotyping and phenotyping can help doctors give patients the most effective drug therapy.

NCT ID: NCT00006444 Completed - HIV Infections Clinical Trials

The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women

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

The purpose of this study is to see how often human papillomavirus (HPV) occurs in HIV-infected women who have not taken anti-HIV drugs and to learn whether taking anti-HIV drugs will affect HPV in women. HIV infection increases the risk of getting HPV infection. Findings suggest that HIV infection as well as a weakened immune system may increase the chances of getting HPV. Aggressive anti-HIV medication has been shown to strengthen the immune system. Researchers want to learn whether anti-HIV drugs affect the HPV virus or decrease the chances of getting HPV. This study is important because it may provide important information to help manage a woman's health and to determine a woman's risk for developing problems with the cervix (outer end of the uterus).

NCT ID: NCT00006443 Completed - HIV Infections Clinical Trials

Effectiveness of Anti-HIV Drugs in Patients Who Have Not Received Previous Anti-HIV Drugs During Different Stages of HIV Infection

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

The purpose of this study is to compare changes in HIV levels and certain immune cells among patients at different stages of HIV infection. This study will also see how a combination of stavudine (d4T), lamivudine (3TC), indinavir (IDV), and nelfinavir (NFV) affects these levels. Current findings in anti-HIV drug treatment have led to a greater understanding of the background of HIV. To find the best anti-HIV treatment to eliminate all HIV viruses, cells and tissues infected with the HIV virus are examined after combination anti-HIV treatment, when the level of HIV infection is low. The ERADICATE study will examine the idea that HIV viruses can be eliminated at any stage of infection over time.

NCT ID: NCT00006442 Completed - HIV Infections Clinical Trials

The Effects of Anti-HIV Drugs on the HIV Virus in HIV-Infected Patients

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

The purpose of this study is to examine the HIV virus in the blood and lymphoid tissues of patients taking anti-HIV medications. HIV infection is closely linked to the growth of the HIV virus in the body. Much of this information was obtained from studying how the HIV virus grows in circulating blood. Recent studies have shown that the lymphoid tissue (part of the immune system) is a major site where HIV is found in the body and is also where much of the HIV virus growth occurs. This study will examine not only blood but also lymphoid tissue to gain a better understanding of the disease and how to treat it.

NCT ID: NCT00006441 Completed - HIV Infections Clinical Trials

Effectiveness of Adding Interleukin-2 to Anti-HIV Drugs in Patients Recently Infected With HIV

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

The purpose of this study is to see whether taking interleukin-2 (IL-2) and other anti-HIV drugs affects the course of HIV disease in patients with primary HIV infection (the time period that immediately follows infection with HIV). After primary HIV infection, the actual infection is spread through an increasing amount of HIV virus in the body. Studies have shown that, by taking a combination of anti-HIV drugs, it is possible to reduce the amount of HIV in the body to almost undetectable levels. This study will find out if starting anti-HIV drugs during primary infection will interrupt or reduce the spread of HIV in patients' bodies.

NCT ID: NCT00006440 Completed - HIV Infections Clinical Trials

A Test of Behavioral Intervention for Women at High Risk for HIV Infection

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

The purpose of this study is to find out if it is possible to conduct a group counseling program for women at risk for HIV infection. Women have been the fastest-growing group with new AIDS diagnoses. The need for ways to reduce HIV infection in women is urgent. It is important to reduce the risk of HIV infection through sexual contact, but it is also important to address drug use. Group counseling may be an effective method.

NCT ID: NCT00006439 Active, not recruiting - HIV Infections Clinical Trials

Effects of Home Visits on Medication Adherence in Children and Youth With HIV

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

Adherence to complex medication regimens is critical to successful treatment of HIV infection. Unfortunately, adherence to medical regimens with conventional interventions averages 50% in chronic disease. We have observed that adherence barriers that were unrecognized by providers in the clinic setting have been detected during home visits. It is possible that recognition and interventions to resolve adherence barriers observed during home visits may improve adherence. This proposal will test the hypothesis that home-visits which identify previously unrecognized adherence barriers and provide support and education will increase medication adherence among children and youth with HIV infection and improve the patient/health care provider relationship. Specific aims of the study are: 1. Determine the impact of a series of home-visits on adherence to medication regimens for HIV infected youth and children. 1a. Adherence to medical regimens will be assessed before and after the series of home-visits using a self-report questionnaire and Microelectronic Monitoring System (MEMS) or in-home pill count. 1b. For each of these measures a percentage of adherence will be calculated and compared from a baseline to after the final home visit and after the six month follow up period. 2. Assess the changes in patient satisfaction from baseline to after the home-visits using a questionnaire completed by the patient/family. 3. Incorporate a pilot study to assess the changes in the provider's knowledge of the patient's family characteristics and home circumstances relevant to adherence following the home visits.

NCT ID: NCT00006415 Withdrawn - HIV Infections Clinical Trials

A Study of Patients Who Recently Have Been Infected With HIV

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

The purpose of this study is to find out if anti-HIV drugs, taken by patients who are newly infected with HIV, can make the level of HIV in the body too low to detect. Studying patients who recently have been infected with HIV may help researchers understand how HIV infection works and how anti-HIV drugs may help these patients. Approved anti-HIV drugs can reduce the amount of HIV, but more research needs to be done in newly infected patients. This study will look at recently HIV-infected patients to study the progression of HIV disease and to see whether anti-HIV drugs can reduce the level of HIV.