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NCT ID: NCT00775125 Completed - HIV Clinical Trials

VX-950-TiDP24-C124: A Phase I Trial to Investigate the Potential Pharmacokinetic Interactions Between Telaprevir and Darunavir/Ritonavir and Between Telaprevir and Fosamprenavir/Ritonavir at Steady-state.

Start date: June 2008
Phase: Phase 1
Study type: Interventional

The primary objectives are to determine the effect of steady-state DRV/rtv 600/100 mg twice daily (b.i.d.) on the steady-state pharmacokinetics of telaprevir 750 mg every (q) 8h and 1125 mg q12h and vice versa;- to determine the effect at steady-state of fAPV/rtv 700/100 mg b.i.d. on the steady-state pharmacokinetics of telaprevir 750 mg q8h and 1125 mg q 12h and vice versa; to determine the steady-state pharmacokinetics of telaprevir 750 mg q8h versus telaprevir 1125 mg q12h, alone and during coadministration of either steady-state DRV/rtv 600/100 mg b.i.d or fAPV/rtv 700/100 mg b.i.d.

NCT ID: NCT00774683 Completed - HIV Clinical Trials

A Pilot Study to Characterize the Pharmacokinetics of Raltegravir in the Cervicovaginal Fluids of HIV-infected Women

Start date: August 2008
Phase: N/A
Study type: Observational

The purpose of this research sub-study is to learn about the levels of an antiretroviral (ARV) medication called Raltegravir, and response to HIV virus in the genital tract of HIV-positive women. We would like to see how this study medication is tolerated, and how the body processes the study medication in women who are HIV-positive. More specifically, we are interested in how Isentress® might penetrate into the female cervicovaginal secretions thereby potentially reducing the amount of HIV in those secretions. A reduction in the amount of HIV in genital secretions may prevent female subjects from transmitting HIV to their sexual partners. This information will help the research team know how a medication such as Isentress® might be used to prevent the sexual transmission of HIV.

NCT ID: NCT00772551 Completed - HIV Clinical Trials

Raltegravir and Ezetimibe PK Study

Start date: June 2008
Phase: Phase 1
Study type: Interventional

Evaluation of the pharmacokinetics and safety of raltegravir and ezetimibe when co-administered to male and female healthy volunteers.

NCT ID: NCT00771537 Completed - HIV Clinical Trials

HIV Testing & Womens Attitudes on HIV Vaccine Trials

Start date: November 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test the effects of different persuasive informational messages on rates of rapid HIV testing and willingness to participate in a HIV vaccine clinical trial. Adult African-American, non-Latina White, and Latina women will be recruited. Women will initially be randomized to 4 groups: 1. no message control; 2. 1-sided message that mentions benefits of HIV testing; 3. 2-sided message that acknowledges minor opposition to testing, then refutes the opposition; and 4. 2-sided message that acknowledge stronger opposition to testing, then refutes the opposition. Women will be offered HIV testing, then re-randomized to a similar set of 4 messages related to HIV vaccine trials. There will therefore be 16 groups in total (4 X 4).

NCT ID: NCT00767117 Completed - HIV Clinical Trials

TMC125-TiDP2-C197: A Phase I Trial to Investigate the Pharmacokinetic Interaction Between Lopinavir/Ritonavir and TMC125 Both at Steady-state in Healthy Volunteers.

Start date: September 2008
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the effect of steady-state concentrations of LPV, co-administered with a low dose of ritonavir, on the steady-state pharmacokinetics of TMC125 and to determine the effect of steady-state concentrations of TMC125 on the steady-state pharmacokinetics of LPV, co-administered with a low dose of ritonavir.

NCT ID: NCT00766818 Completed - HIV Clinical Trials

The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet

Start date: January 2007
Phase: Phase 1
Study type: Interventional

In this study, we are looking at blood concentrations of Kaletra in HIV positive patients during pregnancy. The patients will come in for 4 visits lasting ~24hrs. These visits take place at 20-24 weeks, 30 weeks, 32 weeks and 8 weeks post-partum. At the end of vist 2 (week 30), we will increase your dose to 2 adult Kaletra tablets, and one pediatric Kaletra tablet (total dose 500/125mg). The dose will remain increased until you are 2 weeks post partum, then it will return to the standard 2 adult tablets (400/100mg).

NCT ID: NCT00765271 Completed - HIV Clinical Trials

Abacavir Pharmacokinetic Study in the Absence/Presence of Darunavir/Ritonavir or Raltegravir in HIV-infected Subjects

Start date: May 2008
Phase: Phase 1
Study type: Interventional

The study is being conducted as we have found that many patients with Human Immunodeficiency Disease (HIV) require a combination of different drugs to treat the HIV infection. Before using different combination of drugs, it is important to do studies to see if the drugs will affect the activity of one another. The study aims to help us understand if darunavir/ritonavir or raltegravir have any effects on levels of abacavir in the blood. The purpose of the study is to assess the pharmacokinetics (how a drug is absorbed, distributed and eliminated from your body) of abacavir in the absence and in the presence of darunavir/ritonavir and raltegravir.

NCT ID: NCT00764998 Completed - HIV Clinical Trials

Influenza Vaccine in HIV

Start date: October 2008
Phase: Phase 3
Study type: Interventional

The purposes of this research study are: 1. to see if there is a difference in the quantity of protective influenza antibodies produced by different doses of the Fluviral vaccine 2. to see if these different vaccine dosing schedules reduce flu-like illness and/or reduce laboratory documented influenza in HIV Infected adults.

NCT ID: NCT00763958 Completed - HIV Clinical Trials

Relapse Prevention to Reduce HIV Among Women Prisoners

Start date: May 2008
Phase: Phase 4
Study type: Interventional

This study is a feasibility and acceptability study assessing whether providing buprenorphine for women under criminal justice supervision leaving a controlled environment and returning to the community would prevent opioid relapse and reduce HIV risk behaviors.

NCT ID: NCT00757900 Completed - HIV Infections Clinical Trials

Efficacy of Influenza Vaccine in HIV Infected Adults

Start date: April 2008
Phase: Phase 4
Study type: Interventional

Vaccination of HIV infected individuals with the sub-unit influenza vaccine is safe; however it induces only moderate immune responses and likewise is modest in its protection compared to HIV uninfected individuals. Based upon the available data, the South African Thoracic Society has provisionally recommended the use of influenza vaccine in HIV infected individuals with CD4+ counts of > 200/ml and viral loads of < 100 000 copies/ml.(Green R et al. In press, SAMJ). This proposal is however based upon recommendations made elsewhere with minimal level of evidence regarding its benefit, and no evidence from countries with a high prevalence of HIV. Very few HIV infected adults, however, actually do receive influenza vaccine in South Africa, partly because of the absence of compelling data regarding the burden of disease in Africa as well as lack of vaccine effectiveness and issues related to physician awareness and access to influenza vaccine in the public immunization program. The conflicting evidence, between developed countries and Africa, regarding the effectiveness of PPV highlight the drawbacks of extrapolating vaccine effectiveness data from developed countries to developing countries. Differences in the epidemiology of HIV between developed countries in which the prevalence of HIV is low to that of high-burden sub-Saharan African countries include: - differences in the mode of transmission of HIV and demographics of the infected population. - differences in standard of care, including access to prophylaxis against opportunistic infections and use of highly active anti-retroviral therapy (HAART) - differences in risk for disease from opportunistic pathogens, e.g. Mycobacterium tuberculosis, etc. These differences may all contribute to differences in the risk and severity of influenza illness among HIV infected adults from these communities as well as possibly responsiveness and effectiveness of vaccination. The investigators are conducting a double-blinded, placebo controlled randomized trial at the HIV treatment clinic at Helen Joseph Hospital to determine the effectiveness of influenza vaccination in HIV infected adults in South Africa. The significance of the findings from this study will help quantify the burden of influenza illness in African HIV infected adults, as well as assist in making more informed recommendations for the use of influenza vaccine in HIV infected adults and in guiding national policy for preparing for a future influenza virus-pandemic.