1 |
NCT01576731 |
Completed |
Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP) |
|
- Drug: Tenofovir, Emtricitabine, Lopinavir/r
- Drug: Tenofovir, Emtricitabine, Raltegravir
|
Interventional |
Phase 4 |
- Hospital Clinic of Barcelona
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Proportion of patients dropping out before the 28 days of postexposure prophylaxis
|
240 |
All |
18 Years and older (Adult, Senior) |
NCT01576731 |
2011-003799-35 |
RAL-PEP |
July 2012 |
July 2014 |
July 2014 |
April 12, 2012 |
April 1, 2015 |
|
- Hospital Clínic of Barcelona
Barcelona, Spain
|
2 |
NCT01583439 |
Terminated |
The Mochudi Prevention Project ART Protocol |
|
- Drug: highly active antiretroviral therapy: Lopinavir/Ritonavir, Lamivudine, Zidovudine, Efavirenz, Tenofovir Disoproxil Fumarate, Emtricitabine
|
Interventional |
Not Applicable |
- Harvard School of Public Health
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The proportion of individuals with CD4≥250 cells/mm3 and VL≥50,000 cp/mL who start 3-drug ART
- The proportion of patients experiencing Grade 3 or 4 clinical or laboratory adverse events by the end of follow-up
- The proportion of participants with excellent adherence (defined as participant self-report of taking at least 95% of doses of antiretrovirals during the previous 4 days, on all assessments) by the end of follow-up
- (and 5 more...)
|
11 |
All |
16 Years to 64 Years (Child, Adult) |
NCT01583439 |
BHP041 R01AI083036 |
|
September 2012 |
February 2013 |
September 2013 |
April 24, 2012 |
March 19, 2015 |
|
- Deborah Retief Memorial Hospital
Mochudi, Botswana
|
3 |
NCT01578889 |
Completed |
Evaluating the Safety of and Immune Response to HIV-MAG DNA Vaccine With or Without Plasmid IL-12 Adjuvant Delivered Intramuscularly Via Electroporation Followed by VSV-gag HIV Vaccine Boost in Healthy, HIV-Uninfected Adults |
|
- Biological: HIV-MAG vaccine
- Biological: IL-12 pDNA adjuvant
- Biological: VSV HIV gag vaccine
- (and 2 more...)
|
Interventional |
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Frequency and severity of local injection/EP site reactogenicity signs and symptoms
- Frequency and severity of systemic reactogenicity signs and symptoms
- Magnitude of local injection/EP site pain as measured by a visual analog scale
- (and 8 more...)
|
100 |
All |
18 Years to 50 Years (Adult) |
NCT01578889 |
HVTN 087 11673 |
|
May 2012 |
September 2014 |
October 2016 |
April 17, 2012 |
December 13, 2016 |
|
- Columbia P&S CRS
New York, New York, United States - New York Blood Center CRS
New York, New York, United States - University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, United States - (and 2 more...)
|
4 |
NCT01579695 |
Recruiting |
Long-term Observational Study in HIV Subjects Exposed to EGRIFTA® |
|
- Drug: Tesamorelin for injection
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®
- Time to development or worsening of Type 2 Diabetes Mellitus, diabetic retinopathy, hypersensitivity reactions, hepatic and renal function, adverse events and major adverse cardiovascular events
|
3190 |
All |
18 Years and older (Adult, Senior) |
NCT01579695 |
EMR200147-501 |
|
February 2013 |
December 2029 |
March 2030 |
April 18, 2012 |
August 15, 2016 |
|
- Franco Felizarta, MD
Bakersfield, California, United States - Pacific Coast Medical Group
Fountain Valley, California, United States - University of California CARE Clinic, Los Angeles
Los Angeles, California, United States - (and 28 more...)
|
5 |
NCT01571960 |
Completed |
Evaluating the Safety and Immune Response of a Prime-Boost HIV Vaccine Regimen in Healthy, HIV-Uninfected, Vaccinia-Naive Adults |
|
- Biological: GEO-D03 DNA vaccine
- Biological: MVA/HIV62B (MVA62B) vaccine
- Biological: Placebo for GEO-D03 DNA
- Biological: Placebo for MVA62B:
|
Interventional |
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- GeoVax, Inc.
|
NIH / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Frequency and severity of local injection site reactogenicity signs and symptoms
- Frequency and severity of systemic reactogenicity signs and symptoms and maximum severity of systemic symptoms
- Distribution of values of safety laboratory measures: complete blood count (CBC), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and creatinine
- (and 11 more...)
|
48 |
All |
18 Years to 50 Years (Adult) |
NCT01571960 |
HVTN 094 11827 |
|
April 2012 |
August 2014 |
January 2016 |
April 5, 2012 |
January 24, 2017 |
|
- Alabama CRS
Birmingham, Alabama, United States - Bridge HIV CRS
San Francisco, California, United States - Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States - University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, United States
|
6 |
NCT01581853 |
Completed |
Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily |
|
- Drug: Lopinavir/ritonavir 800 mg / 200mg
|
Interventional |
Phase 4 |
- Daniel Podzamczer
- Hospital Universitari de Bellvitge
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- plasma viral load <40 copies/mL
- Stability in the plasma levels of Lopinavir/ritonavir during all study visits
- Tolerability
- (and 3 more...)
|
21 |
All |
18 Years and older (Adult, Senior) |
NCT01581853 |
KMON 2011-005981-39 |
|
May 2012 |
July 2014 |
July 2014 |
April 20, 2012 |
October 6, 2016 |
|
- Hospital del Mar
Bercelona, Barcelona, Spain - Hospital Universitary de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain
|
7 |
NCT01580657 |
Completed |
Experimental Analysis of HIV Risk Assessment Reactivity in South African Clinics |
- HIV Prevention and Assessment Reactivity
|
- Behavioral: Detailed baseline interview, enhanced HIV intervention
- Behavioral: General baseline interview, enhanced HIV intervention
- Behavioral: No baseline interview, enhanced HIV intervention
- (and 3 more...)
|
Interventional |
Not Applicable |
- Medical College of Wisconsin
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
|
- Reactivity assessment
- Risk Behavior Frequency
|
1728 |
All |
18 Years and older (Adult, Senior) |
NCT01580657 |
PRO00005529 5R01MH077515-04 |
|
September 2006 |
October 2010 |
October 2010 |
April 19, 2012 |
April 19, 2012 |
|
- Site B Youth Clinic
Khayelitsha, South Africa
|
8 |
NCT01568892 |
Unknown † Has Results |
Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir |
- Infection, Human Immunodeficiency Virus
|
- Drug: dolutegravir 50 mg twice daily
- Drug: dolutegravir placebo twice daily
- Drug: Open-label dolutegravir 50mg twice daily
|
Interventional |
Phase 3 |
- ViiV Healthcare
- Shionogi
- GlaxoSmithKline
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8
- Absolute Values in Plasma HIV-1 RNA Over Time
- Mean Change From Baseline in Plasma HIV-1 RNA Over Time
- (and 15 more...)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT01568892 |
116529 |
VIKING-4 |
April 2012 |
October 2012 |
June 2015 |
April 2, 2012 |
February 19, 2014 |
February 19, 2014 |
- GSK Investigational Site
Little Rock, Arkansas, United States - GSK Investigational Site
Bakersfield, California, United States - GSK Investigational Site
Beverly Hills, California, United States - (and 22 more...)
|
9 |
NCT01579214 |
Completed Has Results |
Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda |
|
- Other: Cellular Phone Text Messages
|
Interventional |
Not Applicable |
- Massachusetts General Hospital
- Mbarara University of Science and Technology
- John E. Fogarty International Center (FIC)
- Harvard University
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result
- Clinic Return Within 28 Days of Abnormal CD4 Count Result
|
183 |
All |
18 Years and older (Adult, Senior) |
NCT01579214 |
2011P001538 R24TW007988 |
|
July 2012 |
December 2013 |
April 2015 |
April 17, 2012 |
January 4, 2018 |
December 8, 2017 |
- ISS Clinic, Mbarara Regional Referral Hospital
Mbarara, Uganda
|
10 |
NCT01875952 |
Unknown † |
Diagnosis and Treatment of Co-infection With Human Immunodeficiency Virus /Latent Tuberculosis Infection (HIV/TBL) |
- Human Immunodeficiency Virus (HIV)
- Tuberculosis (TB)
- Latent Tuberculosis Infection (LTI)
|
|
Interventional |
Phase 4 |
- Instituto Nacional de Salud Publica, Mexico
- Instituto Nacional de Enfermedades Respiratorias
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Production of interferon gamma, in response to treatment of latent infection
|
100 |
All |
18 Years to 60 Years (Adult) |
NCT01875952 |
Informed Consent:552 / 306 000000000014520 |
HIV/TB |
May 2010 |
June 2012 |
June 2013 |
June 12, 2013 |
June 12, 2013 |
|
- Instituto Nacional de Salud Publica
Mexico, Cuernavaca Morelos, Mexico - Clínica Especializada CONDESA
Mexico City, D.F, Mexico
|
11 |
NCT01575938 |
Completed |
HIV Prevention Intervention for Young Transgender Women |
- Sexual Transmission of Infection
|
- Behavioral: HIV prevention intervention
- Behavioral: Diet and Nutrition
|
Interventional |
Not Applicable |
- Ann & Robert H Lurie Children's Hospital of Chicago
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Change from baseline in number of unprotected anal and vaginal sex acts in the previous 4 months
|
300 |
Female |
16 Years to 29 Years (Child, Adult) |
NCT01575938 |
R01MH094323 |
LifeSkills |
March 2012 |
October 2015 |
October 2016 |
April 12, 2012 |
December 5, 2017 |
|
- Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States - The Fenway Institute
Boston, Massachusetts, United States
|
12 |
NCT01581086 |
Completed |
Vascular Subphenotypes of Lung Disease in HIV & COPD |
- Pulmonary Artery Hypertension
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- elevated NT-proBNP as a biomarker
|
30 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01581086 |
VAST11060550 |
VAST |
January 2012 |
May 2016 |
January 2017 |
April 19, 2012 |
June 21, 2017 |
|
- University of Pittsburgh
Pittsburgh, Pennsylvania, United States
|
13 |
NCT01585038 |
Completed Has Results |
Efavirenz Versus Rilpivirine on Vascular Function, Inflammation, and Oxidative Stress |
|
- Drug: Efavirenz
- Drug: Rilpivirine
|
Interventional |
Phase 4 |
- Indiana University
- Janssen Services, LLC
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Flow-mediated Dilation of the Brachial Artery
- Inflammatory Markers
- Endothelial Activation Markers
- Oxidative Stress Markers
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT01585038 |
TMC278HIV4002 |
|
July 2012 |
May 2014 |
November 2014 |
April 25, 2012 |
August 14, 2015 |
July 2, 2015 |
- Indiana Clinical and Translational Sciences Institute
Indianapolis, Indiana, United States
|
14 |
NCT01725815 |
Completed |
The Health Access and Recovery Peer Program |
- Hypertension
- Arthritis
- Coronary Artery Disease
- (and 5 more...)
|
- Behavioral: HARP Intervention
|
Interventional |
Phase 3 |
- Emory University
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Health related quality of life
- Patient Activation
- Health Behaviors
|
400 |
All |
18 Years and older (Adult, Senior) |
NCT01725815 |
IRB00047631a 1R01MH090584-01A1 |
HARP |
June 2011 |
June 1, 2016 |
March 31, 2017 |
November 14, 2012 |
July 13, 2017 |
|
- Central Fulton Community Mental Health Center at Grady Hospital
Atlanta, Georgia, United States
|
15 |
NCT01567722 |
Recruiting |
Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies |
- Anal Cancer
- Cervical Cancer
- Lung Cancer
- Lymphoma
|
- Genetic: DNA analysis
- Genetic: RNA analysis
- Genetic: gene expression analysis
- (and 5 more...)
|
Observational |
|
- AIDS Malignancy Consortium
- National Cancer Institute (NCI)
- The EMMES Corporation
- (and 2 more...)
|
Other / NIH / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Mutational spectrum of each type of HIV-1 associated malignancy
|
300 |
All |
18 Years and older (Adult, Senior) |
NCT01567722 |
AMC-083 CDR0000729843 U01CA121947 |
|
July 2012 |
June 2020 |
June 2020 |
March 30, 2012 |
November 17, 2017 |
|
- Moores UCSD Cancer Center
La Jolla, California, United States - UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States - University of Miami
Miami, Florida, United States - (and 11 more...)
|