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HIV Infections clinical trials

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NCT ID: NCT00617643 Completed - HIV Infections Clinical Trials

Nevirapine Drug Levels in HIV Positive Patients Also Receiving Rifampicin for Tuberculosis

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

Triomune is the most commonly prescribed treatment for HIV infection in Uganda. Triomune is manufactured by a generic drug company and consists of three drugs combined in a single pill given twice daily (stavudine 30mg plus lamivudine 150mg plus nevirapine 200mg). It is known that the levels of nevirapine in a patient's blood are highest in the first two weeks of treatment. Therefore it is recommended that patients starting on nevirapine should undergo dose escalation i.e start on 200mg once daily for two weeks and then increase to full dose of 200mg twice daily in order to avoid nevirapine related rash. It is not possible to do dose escalation with a fixed dose combination pill like Triomune and for the two weeks of the dose escalation patients either can buy stavudine plus lamivudine plus nevirapine as separate pills or take Triomune in the morning and then take stavudine plus lamivudine as separate pills in the evening. Rifampicin is used to treat TB and lowers the levels of nevirapine in a patient's blood. This raises two questions in routine clinical practice for patients who are co-infected with HIV and TB (1) Do we need to put our patients to the trouble of dose escalation of nevirapine if they are already on rifampicin? and (2) If we dose escalate nevirapine in patients on rifampicin, are we putting them at risk of low drug levels and development of resistance? The aim of this study is to compare the plasma concentrations of nevirapine in HIV infected patients who are commencing antiretroviral therapy with and without a lead in dose of nevirapine and who are also receiving concomitant treatment with antituberculous therapy which includes rifampicin to assess whether dose escalation of nevirapine is appropriate in this patient population

NCT ID: NCT00617526 Completed - HIV Infections Clinical Trials

Naïve HIV POC Monotherapy Trial

Start date: January 2008
Phase: Phase 2
Study type: Interventional

The primary objective of the trial is: • to evaluate the change from baseline in plasma viral load with placebo and one of up to 4 dose regimens of RDEA806. The secondary objectives are: Efficacy - to describe the nadir of the plasma viral load - to describe the DAVG - to assess the proportion of subjects who reached a drop in viral load of 0.5 log, 1 log, or reach an undetectable viral load - to assess the plasma viral load decay rate - to evaluate immunologic changes (as measured by CD4 and CD8 cells) - to evaluate the genotypic and phenotypic pattern of the virus Pharmacokinetics - to evaluate the pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of RDEA806 Safety - to evaluate the safety and tolerability of bid and qd dosing of RDEA806 as monotherapy

NCT ID: NCT00615810 Completed - HIV Infections Clinical Trials

ROCKET I - Randomized Open Label Switch for Cholesterol Elevation on Kivexa Evaluation Trial

ROCKET I
Start date: March 2008
Phase: Phase 4
Study type: Interventional

This study aims to investigate whether patients switching their backbone from Kivexa to Truvada, who already have raised total cholesterol prior to switching, have an improvement in their total cholesterol after 12 weeks of treatment. If an improvement is demonstrated the study aims to show whether this has a beneficial effect on the patient's overall cardiovascular risk and long term prognosis.

NCT ID: NCT00615745 Completed - HIV Infections Clinical Trials

ONCE - Only Nocturnal Combination Evaluation of Antiretroviral-Experienced HIV 1 Infected Subjects Switching to Atripla

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

A single tablet regimen (STR) of efavirenz, emtricitabine and tenofovir disoproxil fumarate (tenofovir DF) is the first complete HAART that is offered as one tablet once a day. The individual components of this HAART regimen have demonstrated efficacy and safety in HIV treatment-naive patients and offer simplification that in turn may increase adherence and improve clinical outcomes. This study aims to evaluate the effectiveness (efficacy, safety and tolerability) of a STR simplification strategy in patients on HAART who have achieved viral suppression in a real world clinical setting.

NCT ID: NCT00615563 Completed - HIV Infections Clinical Trials

Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)

Start date: March 2007
Phase: Phase 4
Study type: Observational

The primary objective of this trial was to assess the presence of susceptibility to tipranavir and other ARVs of the HIV-1 isolates in treatment experienced patients. The secondary objective was to examine clinicians' use of HIV drug resistance testing in treatment experienced patients currently failing a PI based HAART regimen.

NCT ID: NCT00615290 Completed - HIV Infections Clinical Trials

Pharmaco-epidemiological Description of the Population Treated With Aptivus Under Market Conditions, Safety & Efficacy

Start date: June 2007
Phase: N/A
Study type: Observational

To obtain information on clinical practices for patients treated by Aptivus in real life

NCT ID: NCT00615134 Completed - HIV Infections Clinical Trials

INNOVE Study: A Study of 3 Months Induction With Fuzeon (Enfuvirtide) + Optimized Background (OB) Versus OB Alone in HIV-1 Infected Patients With Virological Failure.

Start date: January 2008
Phase: Phase 2
Study type: Interventional

This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon + optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with virological failure. Eligible patients will be randomized to recei ve either new optimized treatment alone, or optimized treatment + Fuzeon 90mg s. c. twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible for a patient to receive several additional 3 month periods with F uzeon, in the case of new virological failure. The anticipated time on study tre atment is 3-12 months, and the target sample size is <100 individuals.

NCT ID: NCT00614302 Completed - HIV Infections Clinical Trials

Italian Prospective Data Collection for Better Patient Characterization in a Highly Treatment Experienced Population

Start date: June 2007
Phase: N/A
Study type: Observational

Data collection for better patient characterization in a highly treatment experienced population. Studying the clinical practice for the treatment of HIV multiexperienced patients in the real life. The research will be divided into two phases: - The first phase intends to define and understand the clinical practice using a questionnaire about general topics: definitions of multiexperienced patients and VL failure, therapeutic strategies and behaviour in particular cases. - The second part of the research will collect the clinical data of double PIs failure patients.

NCT ID: NCT00613379 Completed - HIV Infections Clinical Trials

PRO 140 by IV Administration in Adults With HIV-1 Infection

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

The purpose of this study is: 1. To assess and characterize the PK and PD of PRO 140 administered IV 2. To assess the antiviral activity of PRO 140 3. To assess the safety and tolerability of PRO 140

NCT ID: NCT00613249 Completed - HIV Infections Clinical Trials

A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal Gels

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

IPM 012 is a double-blind, randomized, placebo-controlled phase I study conducted at one research center in Belgium among 36 healthy, HIV-negative women of 18-40 years of age, randomized in a 1:1:1 ratio to assess plasma, vaginal fluid and vaginal tissue levels and the pharmacokinetics of dapivirine when applying either Dapivirine Gel 4750, 0.05%, 2.5g or Dapivirine Gel 4789, 0.05%, 2.5g intravaginally for 11 days (1 day followed by a 3 day washout period and then 10 consecutive days); and to assess the safety of these gels as compared to the intravaginal HEC-based universal placebo gel.