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HIV Seronegativity clinical trials

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NCT ID: NCT00076232 Completed - HIV Infections Clinical Trials

A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes

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

Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence of genital sores is a significant risk factor for becoming infected with HIV. This study will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men who sleep with men (MSM). Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition, twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection among high risk, HSV-2 seropositive WSM and MSM.

NCT ID: NCT00075062 Completed - HIV Infections Clinical Trials

A Study of Male Rectal Samples in Preparation for Future Rectal Microbicide Trials

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

Microbicides are drugs that destroy microbes such as viruses and bacteria. Rectal microbicides may be able to prevent transmission of HIV during anal intercourse. The purpose of this study is to obtain rectal samples from men to learn information that may be valuable in future clinical trials of rectal microbicides.

NCT ID: NCT00065741 Completed - HIV Seronegativity Clinical Trials

Botanical/Drug Interactions in HIV: Glucuronidation

Start date: September 2003
Phase: Phase 1
Study type: Interventional

A series of clinical studies will be conducted in normal, healthy adult volunteers to evaluate the potential for alterations in the pharmacokinetics of anti HIV drugs when botanicals/nutriceuticals are given concurrently via the oral route. Both the drugs and botanicals are known to rely upon or to modulate, respectively, metabolism via glucuronidation.

NCT ID: NCT00056953 Completed - Health Behavior Clinical Trials

Peer Mentors for Adolescents in HIV Affected Families

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

This study will evaluate the effectiveness of a peer mentoring program designed for youths ages 9 to 15 whose parents or guardians are HIV infected. The program will focus on the youths' mental health, school performance, alcohol and drug use, personal and social behaviors, and behaviors that might expose them to HIV. The study is expected to enroll predominantly minority youth.

NCT ID: NCT00055237 Completed - HIV Infections Clinical Trials

Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients

Start date: February 2003
Phase: Phase 2
Study type: Interventional

This study will examine the safety and effectiveness of the experimental drug bevacizumab for treating both non-acquired immune deficiency syndrome (AIDS) and AIDS-associated Kaposi's sarcoma (KS). KS tumors depend on the formation of new blood vessels for their growth. Bevacizumab is an antibody to a protein called vascular endothelial growth factor (VEGF) that is produced by the body and is involved in blood vessel growth. Bevacizumab may block the action of VEGF, and thus help shrink KS lesions. Patients 18 years of age and older with Kaposi's sarcoma that is restricted to the skin and is not life threatening may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), chest x-ray, and, if needed, imaging studies to evaluate internal tumors. Participants will receive bevacizumab intravenously (by vein) once a week for 2 weeks and then every 3 weeks at the National Institutes of Health (NIH) Clinical Center. The first infusion takes about 90 minutes, the second takes about 60 minutes, and subsequent infusions take about 30 minutes. Infusions may take longer, however, if the drug is better tolerated at a slower infusion rate. Patients will be evaluated with the following tests and procedures: - Physical examination, assessment of drug side effects, measurement of KS lesions, and photographs of lesions once a week for the first 6 weeks of therapy, and then every 3 weeks. - cluster of differentiation 4 (CD4) cell counts and human immunodeficiency virus (HIV) viral load in HIV-positive patients every 12 weeks. - Biopsies of lesions: upon entering the study, at week 12, and at the time of a response of the tumor to therapy or at the end of treatment, if treatment ends at week 18 or later. - Additional biopsies, if requested. (Additional biopsies are not required.) - Other procedures, such as computed tomography (CT) or magnetic resonance imaging (MRI) scans, if medically indicated. Patients may continue bevacizumab therapy indefinitely if they are benefiting from it, as long as they have no substantial toxicity or other conditions that would cause them to stop receiving it and the protocol remains open.

NCT ID: NCT00053612 Completed - HIV Infections Clinical Trials

Vitamin A to Reduce HIV in Vaginal Secretions and Prevent Viral Transmission

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

HIV infected individuals with vitamin A deficiency may be more likely to transmit the virus to others than HIV infected individuals who have normal levels of vitamin A. The presence of HIV DNA in vaginal secretions may indicate a greater risk for transmission of HIV to others. The purpose of this study is to determine if taking vitamin A decreases the level of HIV DNA in vaginal secretions.

NCT ID: NCT00048282 Completed - HIV Infections Clinical Trials

HIV Prevention Preparedness Study

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

The purpose of this study is to provide researchers with information that will help them prepare for a future study to test the efficacy of two anti-HIV vaginal gels. This study will also estimate how likely people living in certain areas are to become infected with HIV and other infections passed during sex.

NCT ID: NCT00047931 Completed - HIV Seronegativity Clinical Trials

HIV-1 Vaccine Test in Uninfected Adult Volunteers

Start date: October 17, 2002
Phase: Phase 1
Study type: Interventional

This study will test the safety of an experimental vaccine against HIV and examine whether it induces an immune response to HIV. A vaccine is a substance given to try to create resistance or immunity to a disease or infection. The vaccine in this study is made from DNA (genetic material) of four HIV proteins called 'gag', 'pol', 'Nef', and 'Env'. Injected into a human, the viral DNA instructs the body to make small amounts of some HIV proteins. This study will see if the body then creates an immune response to these proteins. Study participants cannot catch HIV or AIDS from the DNA vaccine or any proteins made from it. Healthy normal volunteers between 18 and 40 years of age may be eligible for this study. Candidates will be screened with a medical history, physical examination and blood and urine tests. Women will also have a pregnancy test. Women enrolled in the study must either be infertile (e.g., due to menopause or hysterectomy) or must agree either to abstain from heterosexual sex or to practice birth control for at least 21 days before beginning the study and throughout its duration. Participants will be randomly assigned to receive either the experimental vaccine or a placebo (a salt solution that does not contain any active substance) and will be divided into three groups, based on their entry into the study. Of the first seven people enrolled (Group 1), five will receive a 2-mg dose of vaccine and two will receive placebo. If the vaccine is safe at this dose, then in Group 2, five people will receive a 4-mg dose of vaccine and two will receive placebo. If this dose is safe, then in Group 3, thirty people will receive an 8-mg dose of vaccine and six will receive placebo. All participants will receive three injections in an upper arm muscle-one injection a month for three months-with a needle-less device called a Biojector 2000® (Registered Trademark). At the time of each injection, participants will be observed for at least 1 hour after immunization. At home, they will record their temperature and any symptoms they may experience, including any effects at the injection site, for at least 7 days, or as long as the symptoms remain. If symptoms occur, participants will report them immediately to the clinic staff and, if necessary, come to the clinic for an examination. Participants will have about 10 clinic visits during the study. Most visits will last about 2 hours; those on vaccination days will last about 4 hours. ...

NCT ID: NCT00031304 Completed - HIV Infections Clinical Trials

Screening Protocol for HIV Vaccine Studies

Start date: February 27, 2002
Phase:
Study type: Observational

Healthy volunteers will be screened under this protocol for possible participation in a study testing a vaccine against HIV, the virus that causes AIDS. Healthy adults 18 to 60 years of age may be eligible for this study. Participants must be in good general health with no history of significant medical problems or abnormal laboratory test results. Pregnant or breast-feeding women and people infected with HIV will not be enrolled. Participants enrolled in this protocol will undergo the following tests and procedures within 8 weeks before the start of the experimental vaccine study: - Medical history, including history of sexual activity and drug use - Physical examination - Pregnancy test for women of childbearing age - Blood and urine tests to evaluate possible medical problems such as liver and kidney function; to evaluate immune function; and to test for HIV, hepatitis and syphilis Individuals who are identified through this screening protocol as possible candidates for an HIV vaccine trial will be provided additional information about study options.

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.