
A Study of Stem Cells and Filgrastim
HIV InfectionsTo determine the safety of stem cell harvesting after administration of filgrastim ( G-CSF ) to mobilize bone marrow stem cells into the peripheral blood in patients at various stages of HIV-1 infection as well as in HIV-negative volunteers. To determine the surface phenotypic and functional characteristics as well as the viral load in the stem cells obtained following this procedure.

Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children
HIV InfectionsThe purpose of this study is to determine the best dose of T-20, a new anti-HIV drug, to treat HIV-infected children. T-20, unlike other anti-HIV medications, lessens the ability of HIV to infect certain cells (T cells) in the body. Doctors hope to better treat HIV by adding T-20 to anti-HIV drug combinations that include 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) and/or a protease inhibitor (PI).

A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly
HIV InfectionsThe purpose of this study is to look at different ways to help patients follow their anti-HIV medication schedules. It is very important that HIV-positive patients take their anti-HIV medications correctly so they get the best possible benefit from them. Taking the drugs correctly, called "adherence," may keep HIV virus levels in the blood (viral load) low for a longer time. However, anti-HIV medication schedules are often complicated, and many patients have difficulty remembering to take their drugs at the correct time. This study will look at 2 different ways to teach patients about the importance of taking their medications correctly and to remind them when to take their medications.

Immune-based Therapy Pilot Study for the Treatment of Primary HIV Infection (PHI-IMD).
HIVPilot study for the treatment of primary HIV infection with the objective to induce a strong specific HIV immune response able to control viral replication without HAART.

The Raltegravir and Ribavirin Pharmacokinetics (PK) Study
HIV InfectionsThe purpose of this study is to look at levels of both a new anti-HIV drug called raltegravir and an existing anti-hepatitis C drug called ribavirin to see if they affect the blood levels of each other when given separately and together. This is a phase I, open-label, prospective, three phase, pharmacokinetic study.

Safety and Efficacy of Reduced Versus Standard Dose Efavirenz (EFV) Plus Two Nucleotides in Antiretroviral-naïve...
HIV InfectionsClinical data suggests that the standard dose of the anti-HIV medication, efavirenz (EFV), could be reduced without compromising its effectiveness. Lower drug doses could have fewer side effects and would make EFV more affordable. The purpose of this study is to compare the safety and effectiveness, over 96 weeks, of standard (600mg) versus reduced dose (400mg) EFV in controlling HIV as part of initial combination antiretroviral therapy.

TMC278-TiDP6-C154: Evaluation of the Possible Influence of Omeprazole Intake - and the pH Increase...
HIV InfectionsThe purpose of this study is to investigate the extent by which intake of 20 mg once daily (q.d.) omeprazole influences the levels of TMC278 in the blood after intake of 25 mg q.d.. This study also investigates - in case levels of TMC278 are reduced when co-administered with omeprazole - whether a double dose of TMC278 (50 mg q.d.) or a separation of intake of both drugs by 12 hours may circumvent a decrease of TMC278 levels in the blood below the clinical effective concentration. Omeprazole is prescribed to reduce the production of gastric acid. Since TMC278 requires gastric acid to be properly dissolved and taken up in the blood circulation, intake of omeprazole has an influence on the levels of TMC278 in the blood circulation. This effect has been revealed in a previously conducted clinical trial, using the combination of 150 mg TMC278 q.d. and 20 mg q.d. omeprazole. The currently proposed study will also further explore the relationship between the levels of TMC278 in the blood at several time points and the acidity of the stomach. Also the short-term safety and tolerability of co-administration of omeprazole 20 mg q.d. and TMC278 25 mg q.d. will be assessed.

Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration...
HIV InfectionHIV InfectionsThis pilot study aims to evaluate Maraviroc intensification strategy during 24 weeks in HIV infected patients under efficient (CV< 50 cp/mL), controlled antiretroviral therapy (≥ 6 months) and uncompleted immune restoration (CD4<350 cells/mL and CD4 earning <100 cells/mL during last 24 months). The study will include 60 patients whose follow up is carried out for 48 weeks. recruitment period will be maintained for 12 months.

Safety and Tolerability Study to Evaluate Lower Dose of GSK2248761 in Antiretroviral Treatment-Naive...
InfectionHuman Immunodeficiency VirusGSK has in-licensed a novel NNRTI-class candidate (GSK2248761, IDX12899) for the treatment of subjects with HIV-1 infection from Idenix Pharmaceuticals. Idenix Pharmaceuticals completed a proof-of-concept study evaluating GSK2248761 monotherapy over seven days in forty treatment-naïve subjects infected with HIV-1. GSK2248761 doses sequentially evaluated were 800 mg QD, 400 mg QD, 200 mg QD and 100mg QD. This study will evaluate a lower dose, or doses, of GSK2248761 to better characterize the dose-response and concentration-response curves. The results from this study will be used to select doses for future clinical studies in HIV-1 infected subjects.

Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805)
Acute HIV InfectionHIV InfectionsThis is a pilot study of treatment of acute HIV infection with a once daily regimen of Emtricitabine, Tenofovir and Efavirenz. The primary objectives of this study are: To determine the safety and tolerability, and the virologic and immunologic efficacy of FTC, TDF, and efavirenz given once daily to patients with acute HIV infection. To assess the impact of once daily therapy combined with a standardized adherence program on treatment adherence, virologic suppression, and rate of viral load decline in blood and infectious fluids (semen, cervico-vaginal secretions). To define the prevalence of genotypic and phenotypic resistance to antiretroviral agents among persons diagnosed with acute HIV infection in the Southeastern United States.