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HIV Infection clinical trials

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NCT ID: NCT00443703 Terminated - HIV Infection Clinical Trials

MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)

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

The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with HIV.

NCT ID: NCT00440947 Completed - HIV Infection Clinical Trials

Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection

Start date: March 2007
Phase: Phase 3
Study type: Interventional

This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV +/r for an additional 48 weeks, each in combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1 infected, HLA-B*5701 negative subjects. All subjects who complete the 84-week study will be eligible to enter the treatment extension phase and continue for an additional 60 weeks. The purpose of this extension is to obtain longer term treatment data in subjects who have completed the 84-week study.

NCT ID: NCT00435838 Completed - HIV Infection Clinical Trials

A Study of Patient Management in HIV-1 Infected Patients Found to Have the Genetic Marker HLA-B*5701

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

This is a retrospective observational study which follows on from CNA106030 (a study evaluating whether prospective genetic screening for HLA-B*5701 can reduce the incidence of hypersensitivity reactions to abacavir). This study aims to collect data on approximately 35 subjects who withdrew from CNA106030 when found to be HLA-B*5701 positive. HIV disease management and adverse event data in these subjects, where the risk/benefit ratio of treatment with abacavir may alter subsequent prescribing, will be collected

NCT ID: NCT00420355 Terminated - HIV Infection Clinical Trials

Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients

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

The objective of this study is to determine the pharmacokinetics of lopinavir, ritonavir, and atazanavir when lopinavir/ritonavir and atazanavir are used in combination.

NCT ID: NCT00395278 Completed - HIV Infection Clinical Trials

Development of Serologic Assays for Human Herpes Virus-8

Start date: October 30, 2006
Phase:
Study type: Observational

Dr. Burbelo and colleagues have developed a technique for rapidly and quantitatively detecting antibody responses in sera to a variety of pathogens using recombinant proteins. We would like to apply this technique to develop an assay for detecting antibodies to HHV-8 (KSHV, the etiologic agents of Kaposi's sarcoma, an AIDS-defining condition). We initially plan to examine samples from patients with Kaposi's sarcoma, since all those patients are almost certainly infected with HHV-8. We are thus using samples from patients with previously diagnosed Kaposi's sarcoma. The samples in question are stored at the NCI FCRF repository operated by SAIC Frederick or in Rockville, MD.

NCT ID: NCT00386659 Terminated - HIV Infection Clinical Trials

Immune Reconstitution in naïve HIV Patients With CD4 <100 Cells/mL When Treated With Lopinavir or Efavirenz.

Start date: n/a
Phase: Phase 4
Study type: Interventional

Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological response in plasma and extra-plasmatic compartments, together with the degree and kinetics of immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when treated with tenofovir and abacavir together with lopinavir or efavirenz.

NCT ID: NCT00386347 Completed - HIV Infection Clinical Trials

A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.

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

This study is a two-part study. Part one is designed to see how different formulations of GSK364735 are absorbed in the body and To see how food affects how GSK364735 is absorbed in the body. Part two is designed to see how repeat dosing affects how GSK364735 is absorbed in the body.

NCT ID: NCT00378976 Completed - HIV Infection Clinical Trials

HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1, HSV-2 Co-infected Men.

Start date: August 2003
Phase: Phase 3
Study type: Interventional

Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The evidence suggests that that HSV is an important cofactor in HIV transmission. The trial's purpose is to assess the reduction in HIV shedding associated with valacyclovir for suppression of HSV-2 reactivation. This proof-of-concept, randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected men, assessed the effects of daily valacyclovir on HIV-1 levels in the plasma and rectal mucosa secretions.

NCT ID: NCT00373945 Completed - HIV Infection Clinical Trials

HLA-B*5701 And Hypersensitivity To Abacavir

Start date: August 2006
Phase: N/A
Study type: Observational

This retrospective case-control study is being conducted to estimate the sensitivity of the pharmacogenetic marker, HLA-B*5701 for hypersensitivity to abacavir (ABC HSR). The specificity of the marker, and its association with ABC HSR, as measured by odds ratios and 95% confidence intervals, will be evaluated as secondary endpoints. Cases will be defined in two ways - subjects who have clinically-suspected ABC HSR and a positive abacavir skin patch test reaction (CS-SPTPos) and subjects with clinically-suspected ABC HSR (CS-HSR), regardless of the results of skin patch testing. The study will include 40 CS-SPTPos Black cases matched with up to 200 abacavir-tolerant controls. In parallel, 40 CS-SPTPos White cases will be matched with up to 200 White controls. Some of the secondary analyses will use cases defined by clinical criteria alone (CS-HSR). Black and White subjects will be analyzed separately because of the differences in ABC HSR rates and in the carriage frequency of HLA-B*5701.

NCT ID: NCT00367952 Completed - HIV Infection Clinical Trials

A Long Term, Safety Study of Apricitabine in HIV-infected Subjects

Start date: August 2006
Phase: Phase 2
Study type: Interventional

The study will examine how safe and effective apricitabine is when given long term (as ongoing treatment) to HIV patients who have already completed the AVX-201 trial