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HIV Infections clinical trials

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NCT ID: NCT00474435 Recruiting - HIV Infections Clinical Trials

Pharmacokinetics of Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Tuberculosis

PETE
Start date: November 2008
Phase: Phase 2
Study type: Interventional

In this pilot study the pharmacokinetics and safety of the antiretroviral combination of co-formulated emtricitabine/tenofovir/efavirenz will be studied in HIV-positive patients with pulmonary tuberculosis (TB) who are concomitantly treated with a standard rifampin-containing tuberculostatic regimen. It is expected that this antiretroviral combination causes minimal drug interactions with the rifampin-containing anti-tuberculosis medication.

NCT ID: NCT00474370 Completed - HIV Infections Clinical Trials

Vicriviroc in HIV-Treatment Experienced Subjects (Study P04889AM8)(COMPLETED)

Start date: May 15, 2007
Phase: Phase 3
Study type: Interventional

Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5 receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells that fight infection). Previous smaller studies in HIV treatment-experienced patients, have shown that vicriviroc is safe and effective. The purpose of this study is to confirm the previous findings in a larger phase 3 study over a 48-week period, and show that when taken in combination with other appropriate HIV drugs, vicriviroc can decrease the level of HIV (viral load) in the blood and that it is well tolerated.

NCT ID: NCT00473018 Completed - HIV Infections Clinical Trials

Behavioral, Clinical and Basic Science Studies of Non-occupational Post-exposure Prophylaxis ("PEP-2")

PEP-2
Start date: n/a
Phase: N/A
Study type: Interventional

This is a randomized trial to compare the effect of standard versus enhanced risk reduction counseling on risk behavior incidence in individuals receiving PEP medications. The study seeks to 1) determine if there are equivalent changes in the incidence of self-reported risk behaviors, STD incidence, and adherence to medications in individuals who receive enhanced risk reduction and adherence counseling and those who received standard risk reduction and adherence counseling; 2) evaluate viral and host biological factors involved in sexual transmission that may either influence PEP efficacy, or themselves be negatively or positively affected by the administration of PEP medications; and 3) contribute to the CDC registry in an attempt to provide crucial data for a case control analysis to establish the efficacy of PEP for sexual and injection drug use exposures. The principal outcome will be the change in participants' number of unprotected sexual acts following administration of PEP. This is defined as the number of prior 3-month acts of high risk unprotected sex, assessed at 12 months following a course of PEP, minus the number of unprotected acts the participant reported in the 3 and 6 months prior to beginning PEP (assessed at baseline). Methods to be used consist of interview data collection, questionnaires, risk reduction and adherence counseling and source recruitment counseling (index subject).

NCT ID: NCT00472719 Completed - HIV Infections Clinical Trials

Safety of and Immune Response to a DNA HIV Vaccine Followed By Boosting With One of Two Serotypes of Adenoviral Vector HIV Vaccine in Healthy Adults

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

The purpose of this study is to determine the safety of and immune response to an experimental DNA HIV vaccine followed by boosting with either an experimental adenoviral vector HIV vaccine of serotype 5 or 35 in HIV uninfected adults. This study will also determine the safety of and immune response to an adenoviral vector HIV vaccine of serotype 5 followed by a booster of an adenoviral vector of serotype 35, or vice versa, in HIV uninfected adults.

NCT ID: NCT00471614 Completed - HIV Infections Clinical Trials

Effects of Uridine Supplementation on Metabolic Side Effects of Stavudine and Zidovudine

Start date: April 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether uridine supplementation will improve insulin sensitivity and overall carbohydrate metabolism in HIV-positive subjects who are currently undergoing treatment with antiretroviral regimens containing stavudine or zidovudine and who have evidence of impaired mitochondrial function and insulin resistance.

NCT ID: NCT00470210 Completed - HIV Infections Clinical Trials

Peginterferon Alfa-2a, Ribavirin and Epoetin β in Coinfected Patients HCV/HIV Not Responding to Previous Treatment Regimens

Start date: May 2007
Phase: Phase 4
Study type: Interventional

This trial will assess the sustained virologic response to treatment with peginterferon alfa-2a combined with high-dose ribavirin in human immunodeficiency virus (HIV)-infected patients with hepatitis C virus (HCV) genotype 1 or 4 coinfection and persistent transaminase elevations. These patients will have been nonresponders to previous regimens with peginterferon alfa and ribavirin therapy at a dosage of 800-1200 mg/d.

NCT ID: NCT00469768 Completed - HIV Infections Clinical Trials

A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

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

IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess safety and tolerability compared to placebo

NCT ID: NCT00469170 Completed - HIV Infections Clinical Trials

A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method

Start date: March 2007
Phase: Phase 0
Study type: Interventional

The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active women.

NCT ID: NCT00466258 Completed - HIV Infections Clinical Trials

LINFOTARGAM: Treatment With Chemotherapy Plus Rituximab and Highly Active Antiretroviral Therapy in Patients With Diffuse Large B Cell Lymphoma and Infection With the Human Immunodeficiency Virus (HIV)

LINFOTARGAM
Start date: October 2006
Phase: Phase 4
Study type: Interventional

Main objective: - To evaluate the applicability of the treatment: 1. To evaluate the treatment toxicity according to the Common Terminology Criteria (CTC) version 3.0 of the National Cancer Institute (NCI). 2. To evaluate opportunistic and non-opportunistic infections after 6 cycles of treatment with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) administered every 14 days and highly active antiretroviral therapy (HAART) in patients with diffuse large B cell lymphoma (DLBCL) and HIV infection. 3. To evaluate the adherence to the treatment with 6 cycles of R-CHOP considering the delays in the administration of the cycles and the reductions in the doses of chemotherapy (planned dose administered in predicted term). Secondary objectives: - To evaluate the efficacy of the treatment in patients with DLBCL and HIV infection after 6 cycles of treatment with R-CHOP administered every 14 days (R-CHOP/14): 1. To determine the global response and complete remission tax. 2. To evaluate the duration of the response. 3. To evaluate the probability of event-free survival in 5 years. 4. To evaluate the probability of global survival in 5 years. - To identify predictive factors of response after 6 cycles of treatment with R-CHOP administered every 14 days in patients with DLBCL and HIV infection. - To evaluate the impact of the therapeutic combination of R-CHOP and HAART in the parameters of the HIV infection (HIV viral load and CD4+ lymphocyte count).

NCT ID: NCT00466180 Completed - HIV Infections Clinical Trials

Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients

POSOVIR
Start date: June 2004
Phase: Phase 4
Study type: Interventional

Taking antiretrovirals once-a-day is considered the simpler way to improve adherence. However, it is not know if this assertion apply to patients taking their medication twice-a-day who change to once-a-day. We hypothesized that once-daily dosing improves adherence.