
Trial Comparing Two Strategies of Vaccination Against Hepatitis B in HIV-infected Patients Non Responding...
Hepatitis BHIV InfectionHIV infected patients exposed to Hepatitis B virus are more susceptible to develop a chronic and severe liver disease, with a major risk of cirrhosis and liver cancer. However, immune response to standard Hepatitis B vaccination is decreased in HIV-infected patients, compared to non HIV-infected individuals, and, in case of response, its durability has to be carefully followed up. This study compares the efficacy of two strategies of revaccination in HIV-infected patients who didn't respond to previous hepatitis B vaccination. Failure is defined by two conditions: non response to the primary immunization (2 to 4 single-dose injections received before the screening visit) and failure to a single 20 µg boost before being included in the study.

Immunogenicity, Safety, and Tolerability of MF59-Adjuvanted Versus Non-Adjuvanted Influenza Vaccines...
H1N1 Influenza VirusHuman Immunodeficiency Virus Type 1 (HIV-1) InfectionThis is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Human Immunodeficiency Virus Type 1 (HIV-1) Infection and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects. Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.

A Trial to Evaluate Ad35-GRIN/ENV HIV Vaccine in Healthy Adult Volunteers
HIVHIV InfectionsThe purpose of this study is to evaluate the safety and immunogenicity of Ad35-GRIN/ENV HIV vaccine and Ad35-GRIN HIV vaccine administered intramuscularly at 0 and 6 months.

Evaluate Tolerability of a Recombinant DNA HIV-1 Vaccine in Healthy Adults
Human Immunodeficiency VirusHIV InfectionsThis protocol will evaluate the safety and tolerability of the vaccine EnvDNA in healthy adults. DNA-based vaccines are being studied for the prevention of human immunodeficiency virus (HIV), malaria and hepatitis. DNA vaccines have been well tolerated in human studies to date. The vaccine that will be tested in this study was made from the information that the virus uses to make a small part of the HIV. This small part is called the envelope or coating around the virus. We hope the body will make an immune response against the HIV envelope coat. Our potential HIV DNA envelope vaccine is called EnvDNA.

Pilot Study Evaluating Interruption of Enfuvirtide (Fuzeon, T20) in Patients With Enfuvirtide Resistance...
HIV InfectionsThe goal of this study is to examine whether enfuvirtide (T20, Fuzeon) has continued anti-HIV activity in patients experiencing an incomplete virologic response to an enfuvirtide-based regimen.

Herpes Simplex Virus Type 2 (HSV-2) Suppression to Prevent HIV Transmission
HIV InfectionHerpes Simplex2 moreThe University of Washington has received funding to conduct a proof-of-concept trial to assess the impact of suppression of genital herpes on HIV infectiousness. This study (the Partners in Prevention Study) will enroll HIV discordant heterosexual couples in which the HIV-infected partner is co-infected with herpes simplex virus type 2 (HSV-2) to test the efficacy of twice daily (bid) acyclovir (400 mg) given to the HIV-infected partner to prevent transmission to his/her HIV negative partner(s). This randomized, double-blind, placebo-controlled proof-of-concept trial will provide evidence for the efficacy of HSV-2 suppression with daily acyclovir on HIV transmission among HIV-discordant couples among whom the HIV-positive partner is also HSV-2 seropositive with CD4 >250. The researchers hypothesis is that, by decreasing the frequency and amount of genital HIV shedding, standard doses of daily acyclovir 400 mg bid will reduce the rate of HIV transmission by 50% in HIV-discordant couples among whom the HIV-infected partner is HSV-2 positive. Under the study protocol version 4.1.1, 3000 HIV-discordant heterosexual couples in which the HIV-positive partner is HSV-2 positive and has a CD4 count >250 will be recruited; participants will be followed for up to 2 years. A 4% per year HIV incidence in the placebo arm is assumed. The first study site began enrolling participants on 17 November 2005. As of September 2006, 14 sites in Eastern and Southern Africa had participated in recruiting the 2300 HIV-discordant couples enrolled to date.

Safety and Immunogenicity of a Plasmid HIV Vaccine in HIV Uninfected Adults
HIV InfectionThe purpose of this study is to determine the safety and immune response to a investigational DNA Plasmid HIV vaccine, ADVAX e/g + ADVAX p/n-t (ADVAX), at three different dosage levels, in adults who are not infected with HIV.

Family-Based HIV Prevention for Latinos
HIV InfectionsThe proposed project will develop and test an HIV prevention intervention for Latino families. This study will: Conduct a pilot "run-through" of an adapted family-based intervention with three cohorts (about 24 families) to determine the feasibility, acceptability, and appropriateness for the target population. Revise the family-based HIV prevention intervention based on the results of the pilot "run-through" and structured exit interviews. Recruit and randomize 100 families into the Latino family-based HIV prevention intervention or a general health promotion condition. Estimate the effect size of the Latino family-based HIV prevention intervention from assessment of changes in HIV-related sexual behavior and attitudes and parental monitoring/supervision over 6 months. Based on a thorough review of the literature, the following is anticipated: The revised intervention will be feasible, acceptable, and appropriate for Latino families and will be enthusiastically received. The family-based HIV prevention intervention will result in safer adolescent sexual behavior, greater change with regard to primary outcome measures of behavior (recent sexual activity, the number of unprotected sex acts, proportion of condom use, and intentions to use condoms), safer HIV-related attitudes, improved parent-child communication skills, and greater parental monitoring than the Latino families in the general health promotion condition.

A Multiple Ascending Dose Study of BMS-707035 in HIV-1 Infected Subjects
HIV InfectionsThe purpose of this clinical research study is to assess the safety, pharmacokinetics and pharmacodynamics of BMS-707035 in subjects infected with HIV-1

Safety of and Immune Response to Two HIV Vaccines: SAAVI DNA-C2 Boosted With SAAVIMVA-C, in HIV-Negative...
HIV InfectionsThe purpose of this study is to evaluate the safety of and immune response to an experimental DNA HIV vaccine followed by boosting with an experimental modified vaccinia HIV vaccine (MVA) in HIV uninfected adults.