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HIV Infections clinical trials

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NCT ID: NCT00337701 Completed - HIV Infections Clinical Trials

BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection

Start date: June 2006
Phase: Phase 4
Study type: Interventional

This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (>4 weeks) administration of Fuzeon with the standard needle and syringe. Patients will be randomized to the B2000 device or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for the next 4 weeks. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00337467 Completed - Clinical trials for Human Immunodeficiency Virus (HIV) Infections

Phase IIIb Study to Evaluate the Effectiveness and Safety of Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in Human Immunodeficiency Virus (HIV)-Infected Subjects Evidencing Virologic Suppression

OREY
Start date: June 2006
Phase: Phase 3
Study type: Interventional

The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced protease inhibitor therapy can maintain virologic suppression without a marked increase in virologic failure.

NCT ID: NCT00336778 Completed - HIV Infections Clinical Trials

Phase 1 Pilot Study of an ART Bridging Regimen in Highly Experienced Patients Unable to Achieve Viral Suppression

Start date: January 2004
Phase: Phase 1
Study type: Interventional

We hypothesize that a simple bridging ARV regimen that tends to select for virus with a low replicative capacity may tend to stabilize CD4 cell counts and HIV viral load and might be an option to consider in patients with MDR HIV. This strategy will provide them with the bridge they desperately need so that they can await the development of new therapies that when used in combination will give them the best chance in achieving complete virologic suppression.

NCT ID: NCT00335686 Completed - HIV Infections Clinical Trials

Study on the Effect of Kaletra + Nevirapine as Maintenance Bitherapy Compared to a Triple Therapy Including Kaletra + Analogues in HIV Patients

Start date: October 2003
Phase: Phase 4
Study type: Interventional

The study aims to evaluate the changes in mitochondrial DNA (mDNA) by means of the mDNA/nuclearDNA (nDNA) ratio as a marker of mitochondrial toxicity following the interruption of nucleoside analogues.

NCT ID: NCT00335322 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

ALTAIR - Alternative Antiretroviral Strategies : a Comparison of Three Initial Regimens

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

In treatment naïve HIV infected subjects, combination antiretroviral therapy including efavirenz combined with tenofovir and emtricitabine will offer non-inferior antiretroviral efficacy over 48 weeks, compared to either atazanavir boosted with ritonavir combined with tenofovir and emtricitabine or tenofovir and emtricitabine combined with zidovudine and abacavir, as assessed by change from baseline plasma HIV-1 RNA viral load.

NCT ID: NCT00334659 Completed - HIV Infections Clinical Trials

A Study to Investigate the Cardiovascular Safety of Apricitabine in Healthy Subjects

Start date: June 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to confirm that apricitabine does not induce any clinically significant effect upon electrocardiogram (ECG) parameters at doses consistent with the maximum exposure expected to occur in clinical practice.

NCT ID: NCT00334256 Completed - Pregnancy Clinical Trials

Tenofovir/Emtricitabine for PMTCT in Africa and Asia (ANRS 12109 TEmAA)

TEmAA
Start date: October 2006
Phase: Phase 2
Study type: Interventional

To study the pharmacokinetic properties, safety and viral resistance pattern of the combination of tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their newborns, with a view to prevention of mother-to-child transmission (PMTCT) of HIV-1 in Africa and Asia.

NCT ID: NCT00333892 Completed - Clinical trials for Human Immunodeficiency Virus

Leukapheresis to Obtain Lymphocytes for Studies on Antiretroviral Naive HIV-infected Patients

Start date: August 2003
Phase: Phase 2
Study type: Observational

To further investigate differences in the immunologic function of various lymphocyte subsets in HIV-infected patients who are treated early in their infection and during the chronic phase of the infection. Studies will also be done to further delineate the various antigen-specific and innate immune responses including characterization of soluble factors associated with primary HIV infection.

NCT ID: NCT00333736 Completed - Clinical trials for Human Immunodeficiency Virus

Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration

Start date: May 2005
Phase: Phase 2
Study type: Interventional

Hypothesis: Patients using enfuvirtide with the Biojector have an improved quality of life, greater satisfaction, and fewer adverse events compared with using the standard needle.

NCT ID: NCT00333684 Completed - Clinical trials for Human Immunodeficiency Virus

Safety, Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid

Start date: December 2004
Phase: Phase 2
Study type: Interventional

Evaluate and record any changes in the Quality of Life and psychological state of the affected study group following treatment with Bio-Alcamid. Evaluate the safety and efficacy of Bio-Alcamid for restoring the natural fullness and contours of the face affected by HIV drug-induced lipoatrophy. Pre-treatment classification and post treatment recording of changes will be performed by, both, the Principal Investigator and the Treatment Specialist and independently by a 'Blinded' Co-Investigator at post treatment Week 12. Safety data for Bio-Alcamid will be collected throughout the duration of the study. Safety will be determined by the rates of procedure-related events and adverse experiences associated with the use of Bio-Alcamid.