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This is the category page. Below are all of the research programs that are associated with it
- HIV Positive -
OBSERVATIONAL STUDY TO EVALUATE THE VIROLOGIC RESPONSE TO SUBSEQUENT COMBINATION ANTIRETROUVIRAL (ARV) THERAPY OF PATIENTS AFTER VIROLOGIC FAILURE ON AN ATV-CONTAINING REGIMEN – Sub Study to IRB #1-20050202 (PROTOCOL #AI424128)
(1_20080404_118)
This study is going to look at patient’s records to see how well or how poorly they have done on the next HIV medication regiment, in patients that failed a drug regimen containing the drug Reyataz (atazanavir).
- HIV Positive Patients -
A MULTI-CENTER, OPEN LABEL, EXPANDED ACCESS TRIAL OF MARAVIROC(PROTOCOL #A4001050)
(2_20070409_118)
This study is looking at an investigation drug Maraviroc tablets in 150 mg dosage units. This is an open label, non-comparative, international, phase 3b safety study of maraviroc in HIV positive, treatment-experienced patients with R5 HIV who have limited or no therapeutic options with approved therapy. Subjects who meet all of the inclusion criteria will receive investigator selected OBT plus maraviroc twice daily to be initiated simultaneously. Ideally, participants will be treated with at least one additional antiretroviral agent to which their virus is susceptible and/or with which they have not been treated.
- HIV Positive Patients -
A MULTICENTER, OPEN-LABEL STUDY EVALUATING THE ANTIVIRAL ACTIVITY AND SAFETY OF ENFUVIRTIDE (ENF) ONCE DAILY (QD) OR TWICE DAILY (BID) IN TRIPLE-CLASS EXPERIENCED HIV-1 INFECTED PATIENTS CHANGING THEIR THERAPY TO A STANDARD OF CARE (SOC) REGIMEN THAT INCLUDES INITIATING AND INTERGRASE INHIBITOR (in EAP) PLUS AN OPTIMIZED BACKGROUND (OB) ANTIVIRAL REGIMEN (AMICI STUDY) (PROTOCOL #ML20837, (RO 29-9800)) (2_20070814_118)
Use of a non-FDA approved drug, MK-0518 with the use of an FDA-approved drug Fuzeon (Enfuvirtide). Participants will be HIV-1 infected. The study will be 34 to 42 week treatment period with a follow-up four weeks after the end of the treatment period. There will be to arms to the study.
- HIV Positive Patients -
AN INTERNATIONAL, MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY OF THE SAFETY OF MARAVIROC USED WITH OPTIMIZED BACKGROUND THERAPY IN TREATMENT-EXPERIENCED HIV-1 INFECTED PATIENTS (Protocol #A4001067)
(1_20081013_118)
This is a five year follow-up study looking at patients receiving an optimized background therapy (OBT) alone; or with maraviroc. Since this is an observational study only there will be no study mandated visits or laboratory test in this non-interventional study. Medical, social and family history data will be collected, along with laboratory, medications, concomitant diagnosis and vital sign data to be analyzed over time.
- HIV Positive Patients -
EFFECT OF ATAZANAVIR ON EARLY VIROLOGIC RESPONSE TO HEPATITIS C VIRUS THERAPY IN HIV CO-INFECTED PATIENTS (Investigator Initiated Protocol)
(1_20081012_118)
This is a retrospective chart review looking at select groups of subjects based on approved criteria looking at a specific antiretroviral medication on HCV virologic outcome.
- HIV Positve Patients -
A STUDY OF SIGNAL INTENSITY OF THE ORAQUICK ADVANCE® HIV 1/2 ANTIBODY TEST AMONG UNTREATED PATIENTS WITH HIV INFECTION (PROTOCOL #OQ-OTCF-6)
(1_20070802_118)
This is an investigational Device, OraQuick® ADVANCE™HIV 1/2 Test. The test is visually read, qualitative, in vitro lateral flow immunoassay for the detection of antibodies to HIV-1 and HIV-2. The device is currently FDA approved for use with oral fluid specimens; whole blood specimens collected either by venipuncture or finger stick phlebotomy and plasma specimens. Additionally, the OraQuick ADVANCE® HIV1/2 Antibody Test is ClIA-waived for oral fluid and whole blood specimens. The product in this study is the approved, commercial test. One sample will be collected for this study, an oral fluid sample collected directly on a swab protruding from the device. The device is then placed into the vial containing the OraQuick developer solution. The oral fluid sample mixes with the developer solution and this fluid enters the device and flows onto the test strip contained inside the plastic housing. Antibodies in the specimen bind to particles on the strip and indicate the result.
- HIV Testing/HIV Negative -
INVESTIGATION OF THE INFLUENCE OF UNRELATED MEDICAL CONDITIONS ON THE SENSITIVITY AND SPECIFICITY OF THE ORAQUICK ADVANCE® HIV 1/2 ANTIBODY TEST (Protocol #OQ-OTCF-5)
(1_20080905_118)
This study is testing an oral swab device which has FDA approval for commercial use. Participants in this study must be HIV negative; and must have one of the following conditions or vaccinations: Autoimmune Disease, Smallpox Vaccination, Influenza Vaccination, Oral Candida Albicans, Hepatitis B Virus, Hepatitis C Virus, Human T-Cell Leukemia virus, Epstein-Barr virus, Cytomegalovirus and/or Herpes Simplex virus. There will be two visits. At the first visit HIV status will be confirmed using a blood test. This blood specimen will also be used to confirm the medical condition. At the second visit, the oral swab device which is being tested will be used to collect oral fluids. This pain free…the participant will swab their gums lightly with the oral swab device.
- HIV Testing/HIV Positive or Negative -
INVESTIGATION OF THE FUNCTION LIMITS AND INTERFERING FACTORS OF ORAQUICK® ADVANCE™ HIV 1/2 ANITBODY TEST – EFFECTS ON SAMPLE INTEGRITY, POTENTIAL INTERFERING FACTORS (PROTOCOL #OQ-OTCF-2)(1_20070507_118)
Use of an investigational device, OraQuick® ADVANCE™ HIV 1/2 Test. This study is designed to collect and test oral fluid specimens with the device in order to screen for certain potentially interfering factors. This is an open, unblended trial.
- HIV Testing/HIV Positive or Negative -
INVESTIGATION OF THE FUNCTION LIMITS AND INTERFERING FACTORS OF ORAQUICK® ADVANCE™ HIV 1/2 ANTIBODY TEST – EFFECT OF USER ERRORS/HUMAN FACTORS, SAMPLING VARIATIONS (PROTOCOL #OQ-OTCF-1)
(1_20070801_118)
This study is using an Investigational Device - OraQuick® ADVANCE™ 1/2 Antibody Test. The OraQuick® ADVANCE™ device is designed to collect and test oral fluid specimens in order to screen for certain potentially interfering factors. This is an open, unblended trial designed to compare the results of intentionally incorrect sampling to correct sampling. Each participant will serve as their own control. Three sub-studies will be performed under the main protocol. Using the device the participant will swab the outside of the upper and lower gums once each with the flat pad of the device. The device is then placed into the vial containing the OraQuick® developer solution. The oral sample mixes with the developer solution and this fluid will indicate in the result window, demonstrating that the test has been carried out correctly and the result is valid.
- Study Closed to Accrual:
HIV Positive -
A PHASE IV, MULTICENTER, CROSS-SECTIONAL STUDY TO EVALUATE THE I50L SUBSTITUTION AMONG SUBJECTS EXPERIENCING VIROLOGIC FAILURE ON A HAART REGIMEN CONTAINING ATAZANAVIR (ATV) (PROTOCOL #AI424128)
(1_20050202_118)
This study is for patients who are virologically failing an ATV-containing regiment. At the first study visit, detailed treatment history, basic demographic information and some questions regarding adherence will be collected. A blood sample will be drawn for genotypic analysis. All study related procedures are completed in one study visit and participants will be notified of testing results within 30 days. It is expected that the study will be open for at least 5 years.
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