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HIV Infections clinical trials

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NCT ID: NCT00028301 Completed - HIV Infections Clinical Trials

Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)

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

This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood.

NCT ID: NCT00028145 Completed - HIV Infections Clinical Trials

Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission

Start date: October 2002
Phase: N/A
Study type: Observational

The purpose of this study is to collect and study clinical and laboratory information about a pregnant or new mother and her medical care that will increase our knowledge of the best care for HIV-infected pregnant women and their children. The rate of transmission of HIV from mothers to their infants has gone down. Specific U.S. Public Health Service guidelines recommend that HIV-infected pregnant women be treated with anti-HIV therapies; but the effectiveness of treatment and safety for the mother and her infant have not been fully examined. This study will monitor the health of women and their infants while they receive anti-HIV therapy. Also, this study will provide information that may be used for future studies.

NCT ID: NCT00028132 Completed - HIV Infections Clinical Trials

Safety and Acceptability of the Anti-Microbe Vaginal Gel, PMPA Gel

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the PMPA gel, which kills microbes, in HIV-infected and HIV-uninfected women. The majority of new HIV infections occur through heterosexual contact. A product that stops or slows the replication of HIV during sexual contact is needed. At present, there are no products that are completely effective. PMPA gel, also known as tenofovir, is an anti-microbe agent that may fight against sexual transmission of HIV and other sexually transmitted diseases (STDs). It is applied to the vagina and gives women the ability to control their disease-prevention activity.

NCT ID: NCT00028119 Completed - HIV Infections Clinical Trials

HIV Incidence and Participation Retention in Pune, India

Start date: August 2002
Phase:
Study type: Observational

The purpose of this study is to ensure that the HIV Prevention Trials Unit (HPTU) in Pune will be able to enroll and retain participants for 2 upcoming HPTN clinical trials. Specifically, this study seeks to find the rate of HIV infection and follow-up among a group of high-risk, HIV-negative non-sexworker women in Pune, as well as among HIV-discordant couples (couples where 1 partner is HIV-infected and the other is not). Phase III studies of HIV prevention require the participation of a large number of people at high risk for HIV infection. It is also important that these participants continue and follow through with the study through the extended period of follow-up. A measurement of HIV incidence and retention rate among high-risk women and HIV-discordant couples is necessary for upcoming HPTN trials. Taken together with the need for estimates of HIV incidence and the need for data to ensure high retention rates, this protocol is important for the HPTN generally and for HPTU in Pune in particular.

NCT ID: NCT00027482 Completed - Healthy Clinical Trials

Immune Responses to HIV in Blood Cells in HIV-Infected and HIV-Uninfected Volunteers

Start date: December 4, 2001
Phase: N/A
Study type: Observational

This study will explore the responses of the immune system to infection with HIV and other pathogens and the changes in these responses over time. Healthy normal volunteers and HIV-infected patients 18 years of age or older may be eligible for this study. Prior to enrollment and yearly thereafter, vital signs, height and weight will be recorded. A medical history will be obtained if relevant to the laboratory research for which the sample will be used. A more extensive history and physical exam is not required but may be performed if deemed necessary by the VRC clinician. A complete blood count will be performed on the day of enrollment and yearly thereafter. Samples will be collected in the following manner: Blood will be drawn from a needle in an arm vein one or more times during the course of the study. From 20 to 150 cc (4 to 30 teaspoonfuls) of blood will be collected at a time. No more than 450 cc (less than 1 pint) of blood will be drawn during any 6-week period. Urine and saliva samples will be collected by the volunteer in private. Swab samples will be collected by a nurse or doctor, using a cotton swab to brush inside the mouth. Samples may be used for the following tests: - Hepatitis and other viral screening-This may include screening for different types of viral liver infections, such as hepatitis A, B, C, D, E, or G; for cytomegalovirus (related to the herpes virus); and for varicella zoster virus (responsible for chicken pox in children and shingles in adults). - Genetic testing-DNA in blood cells may be examined for genetic mutations (physical or chemical changes) or deletions (missing pieces) that affect substances involved in the body's ability to mount an inflammatory immune response. Alterations in the genes for some of these substances have been shown to influence HIV infection. - HLA testing-HLA type is a genetic marker of the immune system. Determining HLA type is necessary in order to do certain research studies. Some HLA types have been associated with an increased risk of diseases like arthritis and other rheumatologic problems. HLA testing may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions. - Other laboratory tests as clinically indicated or required for research needs. Some samples collected in this study may be stored for future research.They will be labeled without identifying information. Those with interesting or strongly positive immune responses may be asked to return to the VRC Clinic to provide samples of urine or oral secretions.

NCT ID: NCT00027365 Completed - HIV Infections Clinical Trials

An Investigational Combination Vaccine Given to People Who Are Not Infected With HIV

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see if the investigational vaccines NefTat and gp120w61d are safe and tolerable in humans and to see how the immune system responds to the vaccines. There have been advances in the treatment and prevention of HIV, but the spread of HIV/AIDS is getting worse. HIV/AIDS is the main infectious cause of death in the world. A vaccine to prevent HIV disease is the best way to try to deal with this situation. Several vaccine products have been tested, but only 2 are still in trial. There is a need for a new product.

NCT ID: NCT00027352 Completed - HIV Infections Clinical Trials

A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)

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

The purpose of this study is to compare two ways of using anti-HIV drugs to help health care providers and patients decide how to best use anti-HIV treatments over many years. Many health care providers now treat patients with daily drugs to keep the viral load as low as possible. This approach helps patients with CD4 counts less than 200-250 cells/mm3 live longer without serious diseases. But it is not known if this is the best way to treat patients with higher CD4 counts. There is information suggesting that these patients may be able to wait to use anti-HIV drugs while CD4 counts are above 250 cells/mm3. Because this study will be carried out over several years, it will provide information on the long-term advantages and disadvantages of these two treatment strategies.

NCT ID: NCT00027339 Completed - HIV Infections Clinical Trials

Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIV

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

Because people infected with HIV strains that are resistant to anti-HIV drugs have fewer effective treatment options, selecting an effective anti-HIV drug combination is difficult. A combination of protease inhibitors (PIs), when added to a patient's current anti-HIV therapy, may decrease viral load and increase drug activity. Tests that measure drug levels in the blood and tests to evaluate the drug resistance of HIV may also be helpful in choosing the best anti-HIV drug combination for a patient. This study will determine whether using these tests to choose a drug combination and adding PIs to that combination will improve the patient's response to anti-HIV therapy.

NCT ID: NCT00027261 Completed - HIV Infections Clinical Trials

Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe and to study how the immune system responds to the vaccine. This trial is designed to determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune response. As of May 2001, over 200 people received the ALVAC-HIV (vCP1452) vaccine at the lower dose. The higher dose of the vaccine to be used in this study has not been given to humans previously. High doses of a similar vaccine have been given to a few people without serious side effects. In a recent study done in mice, higher doses of ALVAC-HIV produced stronger immune responses. It is possible that the doses of ALVAC-HIV given to humans are below the amount needed for the maximum immune response. Because the exact relationship between an increased immune response and its effectiveness in preventing HIV infection is uncertain, the HVTN will use the highest dose that can be manufactured.

NCT ID: NCT00027092 Completed - HIV Infections Clinical Trials

Use of a Test That Evaluates How the Body Handles Insulin and Glucose

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

The purpose of this study is to find out if testosterone gel affects how the body handles insulin and glucose. Specific anti-HIV treatments may increase a patient's risk of certain diseases by causing metabolic problems such as reduced sensitivity to insulin. This substudy will examine how testosterone affects insulin sensitivity. If testosterone increases insulin sensitivity in the patients, then giving testosterone to HIV-infected patients may allow the continuation of anti-HIV treatments without increasing the patients' risk of disease. The test used to determine insulin sensitivity will be a modified frequently sampled intravenous glucose tolerance test (FSIVGTT), which can accurately measure insulin sensitivity.