Pediatric Expanded Access Program-Oral Solution (0831-908)
HIV InfectionsMonitor the safety and tolerability of efavirenz oral solution in combination with Antiretroviral Therapy for the treatment of patients age 3 to 16 years who have failed therapy or who are intolerant to their current therapy. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).
Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV...
HIV InfectionsThis study will evaluate the safety, pharmacokinetics and efficacy of the CCR5 antagonist INCB009471 in HIV-1 infected patients who are antiretroviral therapy naïve, or who are not currently on a HAART regimen and have not received any antiretroviral agents for 3 months prior to the Screening visit. Subjects will receive study medication (INCB009471) admnistered orally or placebo once daily with food for 14 days. Clinical safety laboratories, 12-lead electrocardiograms, physical examinations and virologic assessments, including viral load, viral tropism and CD4+ cell count determinations will be performed at the Screening visit and at regularly scheduled visits throughout the study. A blood sample will also be obtained and stored to potentially determine the genotype of the CCR5 receptor. The primary objectives are: Assess the safety and tolerability of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days; Determine the pharmacokinetics of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days; Evaluate the anti-retroviral activity of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days
A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic...
HIV SeropositivityAcquired Immunodeficiency SyndromeTo Investigate the safety and immunologic activity of AGS-004, an autologous HIV Immunotherapeutic, in HIV-infected adults currently on stable antiretroviral therapy (ART) with durable viral suppression.
A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human...
HIV-1HIV InfectionsThe purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), safety, tolerability and antiviral activity to support dose recommendations of TMC114 with ritonavir and other antiretroviral agents in treatment-experienced, human immunodeficiency virus (HIV)-1 infected children and adolescents.
Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon...
Human Immunodeficiency VirusHypothesis: Patients using enfuvirtide with the Biojector have an improved quality of life, greater satisfaction, and fewer adverse events compared with using the standard needle.
Drug Levels of Tablet and Liquid Forms of Lamivudine, Nevirapine, and Stavudine in HIV Infected...
HIV InfectionsThe purpose of this study is to compare the blood levels, absorption, and breakdown of lamivudine (3TC), nevirapine (NVP), and stavudine (d4T) in a fixed-dose tablet to that of the individual liquid formulations of the same anti-HIV drugs in HIV infected Thai children.
BASTA Study on STI in HIV Infected Patients
HIV InfectionThis is a single center, independent study. The primary objective is to compare efficacy and safety of continuing a conventional HAART in chronically infected HIV patients with a therapeutic strategy based on long term, immunologically driven treatment interruptions. Evaluation will be based on clinical, immunological and virological response. Patients will be randomized in a ratio 1:2 to one of the two treatment arms: Control group continuing the ongoing therapy STI group performing long term CD4 guided structured treatment interruptions In the STI arm patients will stay off therapy until their CD4 count will drop < 400 cells/mcL. At that time point patients will resume the HAART regimen they were assuming before STI and will continue HAART until they CD4 count will raise > 800 cells/mcL and their HIV-RNA will drop below the detection limit of 50 copies/ml. When both the CD4 count and the viral load will be within these pre-set values they will stop therapy again. There is no limit to the number of interruptions and re-start cycles during the study period The study is powered to evaluate equivalence between the two strategies under the assumption of a failure proportion in the control arm at each time point not greater than 5% and a maximum allowed difference of 15%.
Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence
HIV InfectionsThe aims of the study are to investigate individual, combined and added effects of acupuncture and the relaxation response in reducing gastrointestinal symptoms, improving medication adherence and quality of life among people living with HIV/AIDS. The study will also explore the mechanism of these therapeutic effects of acupuncture and the relaxation response.
Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination...
HIV InfectionsAIDS Virus2 moreThe purpose of the study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination therapy containing 2 nucleosides and darunavir/ritonavir in 250 HIV-1 infected patients who have been on Highly Active Antiretroviral Therapy (HAART) and have plasma viral load below 50 copies/ml for at least 24 weeks.
Botswana Tenofovir Oral HIV Prophylaxis Trial
HIV InfectionThis study will test whether taking a pill of tenofovir (an antiretroviral medicine) is safe for sexually-active young adults in Botswana without HIV infection and whether it will reduce their risk of getting an HIV infection.