| 1 |
NCT01095224 |
Completed |
Evaluating Heterologous-Insert Prime-Boost HIV Vaccine Regimens in HIV-Uninfected Adults |
|
- Biological: rAd35 Env A
- Biological: rAd5 Env A
- Biological: rAd5 Env B
|
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 site reactogenicity signs and symptoms, including pain, tenderness, erythema, induration, and maximum severity of pain and/or tenderness
- Frequency and severity of systemic reactogenicity signs and symptoms, including fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and maximum severity of systemic symptoms
- Frequency of adverse events (AEs) categorized by MedDRA body system, MedDRA preferred term, severity and assessed relationship to study products; detailed description of all AEs meeting DAIDS criteria for expedited reporting
- (and 9 more...)
|
180 |
All |
18 Years to 50 Years (Adult) |
NCT01095224 |
HVTN 083
10783 |
|
September 2010 |
October 2012 |
February 2016 |
March 30, 2010 |
August 18, 2017 |
|
- Alabama CRS
Birmingham, Alabama, United States - Bridge HIV CRS
San Francisco, California, United States - The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, United States - (and 5 more...)
|
|
| 2 |
NCT01084954 |
Completed |
Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection |
|
|
Observational
|
|
- George Washington University
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection
|
153 |
All |
18 Years and older (Adult, Older Adult) |
NCT01084954 |
040907 |
|
March 2009 |
April 2016 |
April 2016 |
March 11, 2010 |
June 16, 2016 |
|
- The George Washington University Medical Faculty Associates
Washington, District of Columbia, United States
|
|
| 3 |
NCT01095796 |
Completed
Has Results |
Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults |
|
- Drug: Stribild
- Drug: Atripla
- Drug: Stribild Placebo
- Drug: Atripla Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48
- The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96
- The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144
- (and 4 more...)
|
707 |
All |
18 Years and older (Adult, Older Adult) |
NCT01095796 |
GS-US-236-0102 |
|
March 2010 |
August 2011 |
September 2014 |
March 30, 2010 |
November 11, 2015 |
October 22, 2012 |
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Spectrum Medical Group
Phoenix, Arizona, United States - Health for Life Clinic PLLC
Little Rock, Arkansas, United States - (and 99 more...)
|
|
| 4 |
NCT01098045 |
Completed |
HIV Fat Redistribution and the Evaluation of Brown Fat |
|
|
Observational
|
|
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
|
Other |
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
|
- Brown Fat
- UCP-1
- Indirect Calorimetry
- (and 2 more...)
|
27 |
Male |
20 Years to 60 Years (Adult) |
NCT01098045 |
2009P-001836 |
|
March 2010 |
June 2014 |
August 2015 |
April 2, 2010 |
March 16, 2016 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
|
| 5 |
NCT01087840 |
Completed |
Raltegravir Use as Nonoccupational Postexposure Prophylaxis (NPEP) in Men Who Have Sex With Men |
- HIV Prevention
- HIV Infections
|
|
Interventional
|
Phase 4 |
- Andrew Carr
- Merck Sharp & Dohme Corp.
- St Vincent's Hospital, Sydney
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To describe the safety of 28 days of nonoccupational post-exposure prophylaxis containing raltegravir
- To describe the tolerability of 28 days of NPEP containing raltegravir
- To describe on-drug adherence and regimen completion rates of 28 days of NPEP containing raltegravir
- (and 3 more...)
|
120 |
Male |
18 Years to 70 Years (Adult, Older Adult) |
NCT01087840 |
RAL-NPEP version 1. |
RAL-NPEP |
July 2010 |
May 2012 |
July 2012 |
March 16, 2010 |
April 17, 2014 |
|
- Sydney Sexual Health, Sydney Hospital
Sydney, New South Wales, Australia - St. Vincent's Hospital, 390 Victoria Rd, Darlinghurst
Sydney, New South Wales, Australia
|
|
| 6 |
NCT01087814 |
Completed
Has Results |
Sustiva Levels With Use of a Gel Capsule |
|
- Drug: Efavirenz
- Drug: Over-encapsulated efavirenz
|
Interventional
|
Phase 4 |
- University of Minnesota - Clinical and Translational Science Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Basic Science
|
- Serum Levels of Efavirenz
|
16 |
All |
18 Years and older (Adult, Older Adult) |
NCT01087814 |
0910M73917 |
|
February 2010 |
September 2010 |
September 2011 |
March 16, 2010 |
March 9, 2017 |
September 12, 2014 |
- University of Minnesota
Minneapolis, Minnesota, United States
|
|
| 7 |
NCT01103596 |
Completed |
Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to Antiretrovirals (ARVs) |
|
|
Observational
|
|
- Abbott
- Readitwell
- Lincoln Medical and Mental Health Center
|
Industry / Other |
- Time Perspective: Retrospective
|
- Genotype for resistance determination
- Description of the predictive factors for mutations and of the impact they could have on other protease inhibitors (PIs) used as maintenance treatment (analysis based on available algorithms).
|
94 |
All |
18 Years and older (Adult, Older Adult) |
NCT01103596 |
P06-124 |
EOLE |
March 2008 |
July 2009 |
July 2009 |
April 14, 2010 |
December 14, 2011 |
|
- Site Reference ID/Investigator# 27801
Angers, France - Site Reference ID/Investigator# 27799
Bordeaux, France - Site Reference ID/Investigator# 27790
Grenoble, France - (and 16 more...)
|
|
| 8 |
NCT01092338 |
Completed
Has Results |
Vitamin D Dose Finding Study |
|
- Drug: Cholecalciferol (Vit D3)
|
Interventional
|
Phase 2 |
- Children's Hospital of Philadelphia
- National Institutes of Health (NIH)
- National Center for Complementary and Integrative Health (NCCIH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Safety
- Efficacy of the Two Doses (4000 and 7000 IU/d)
|
44 |
All |
5 Years to 24 Years (Child, Adult) |
NCT01092338 |
09-007332
R01AT005531 |
|
January 2010 |
January 2011 |
January 2011 |
March 24, 2010 |
September 18, 2013 |
September 18, 2013 |
- Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
|
|
| 9 |
NCT01090648 |
Completed |
TMC125HIV1083 - Swallowability of Uncoated 200 mg Etravirine Tablets in HIV-1 Infected Patients |
|
|
Interventional
|
Phase 1 |
- Tibotec Pharmaceuticals, Ireland
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: Single (Participant)
|
- Questionnaire using a 7-point scale to determine the acceptability of swallowing an uncoated 200 mg etravirine (ETR) tablet
|
49 |
All |
18 Years and older (Adult, Older Adult) |
NCT01090648 |
CR017038 |
|
March 2010 |
May 2010 |
May 2010 |
March 22, 2010 |
December 11, 2012 |
|
|
|
| 10 |
NCT01082692 |
Completed |
Study of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants |
- HIV-1 Infection
- HIV Infections
|
|
Interventional
|
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety and tolerability
- T-cell responses
|
12 |
All |
18 Years to 50 Years (Adult) |
NCT01082692 |
HIV-001 |
HIV-001 |
January 2011 |
August 2012 |
August 2012 |
March 8, 2010 |
November 9, 2012 |
|
- University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
|
| 11 |
NCT01088295 |
Completed
Has Results |
HIV and Fat Accumulation |
|
|
Interventional
|
Phase 2 |
- University of California, Los Angeles
- California HIV/AIDS Research Program
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Median Change in Visceral Adipose Tissue (VAT) Volume
- Safety and Tolerability of Telmisartan
|
35 |
All |
18 Years and older (Adult, Older Adult) |
NCT01088295 |
MATH |
MATH |
May 2010 |
June 2011 |
June 2011 |
March 17, 2010 |
June 30, 2014 |
February 18, 2013 |
- UCLA CARE Center
Los Angeles, California, United States
|
|
| 12 |
NCT01090245 |
Completed |
Using Incentives to Improve Parolee Participation and Attendance in Community Treatment |
- Substance Abuse
- HIV Infections
|
- Behavioral: Contingency management: voucher/monetary incentives for treatment attendance
- Behavioral: Information
|
Interventional
|
Not Applicable |
- University of California, Los Angeles
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Community treatment admission
- Community treatment retention
- Participation in HIV testing and counseling
- (and 3 more...)
|
202 |
Male |
18 Years and older (Adult, Older Adult) |
NCT01090245 |
1R01DA025627-01A1 |
PIP |
April 2010 |
January 2014 |
August 2014 |
March 19, 2010 |
May 10, 2017 |
|
|
|
| 13 |
NCT01078246 |
Completed
Has Results |
Post-Licensure Safety Study of ISENTRESS™ (Raltegravir) in a United States Managed Care Network (MK-0518-268) |
|
|
Observational
|
|
- Merck Sharp & Dohme Corp.
- Kaiser Permanente
|
Industry / Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Incidence of AIDS-defining and Non-AIDS-defining Malignancy
- Incidence of Clinically Important Hepatic Events
- Incidence of Clinically Important Skin Events
- (and 4 more...)
|
7124 |
All |
18 Years and older (Adult, Older Adult) |
NCT01078246 |
0518-268
EP08025.006
2010_021 |
|
August 31, 2009 |
December 9, 2014 |
December 9, 2014 |
March 2, 2010 |
July 11, 2017 |
April 7, 2016 |
|
|
| 14 |
NCT01076985 |
Completed
Has Results |
Special Investigation of Kaletra in Pregnant Women |
- Human Immunodeficiency Virus
|
- Drug: Lopinavir/ritonavir (Kaletra)
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number of Patients With Adverse Drug Reactions (ADRs)
|
24 |
Female |
Child, Adult, Older Adult |
NCT01076985 |
PMOS-JAP-00-002 |
|
December 2000 |
December 2010 |
December 2010 |
February 26, 2010 |
January 18, 2012 |
January 18, 2012 |
- Site Reference ID/Investigator# 35862
Aichi, Japan - Site Reference ID/Investigator# 35863
Okayama, Japan - Site Reference ID/Investigator# 35864
Osaka, Japan - (and 2 more...)
|
|
| 15 |
NCT01076972 |
Completed
Has Results |
Drug Use Investigation of Kaletra |
- Human Immunodeficiency Virus
|
- Drug: Lopinavir/ritonavir (Kaletra)
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Total Number of Patients With Adverse Drug Reactions
- Cluster of Differentiation 4 Lymphocyte Count (CD4)
- Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit
- Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents
|
1184 |
All |
Child, Adult, Older Adult |
NCT01076972 |
PMOS-JAP-00-001 |
|
December 2000 |
December 2010 |
December 2010 |
February 26, 2010 |
March 1, 2012 |
March 1, 2012 |
- Site Reference ID/Investigator# 36516
Aichi, Japan - Site Reference ID/Investigator# 36517
Aichi, Japan - Site Reference ID/Investigator# 36518
Chiba, Japan - (and 26 more...)
|
|
| 16 |
NCT01098513 |
Completed |
GSK1349572 Relative Bioavailability Study |
- Infection, Human Immunodeficiency Virus
|
- Drug: GSK1349572 formulation AP
- Drug: GSK1349572 formulation AW
- Drug: GSK1349572 formulation AX
|
Interventional
|
Phase 1 |
- ViiV Healthcare
- GlaxoSmithKline
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Plasma GSK1349572 AUC(0-infinity), AUC(0-t), and Cmax.
- Plasma GSK1349572 t½, tlag, tmax, C24, Vdss/F, CL/F, and MRT.
- Safety and tolerability parameters, including adverse events, concurrent medication, clinical laboratory screens, ECG, and vital signs assessments.
|
24 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01098513 |
113674 |
|
April 2010 |
June 2010 |
July 2010 |
April 2, 2010 |
June 9, 2017 |
|
- GSK Investigational Site
Austin, Texas, United States
|
|
| 17 |
NCT01077765 |
Completed |
Polyacrylamide Hydrogel Injection in HIV-related Lipoatrophy |
- HIV Infection
- Antiretroviral Side Effects
- Lipodystrophy Syndrome Related to HIV Infection
|
|
Interventional
|
Phase 3 |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Cutaneous tissue thickness of the cheeks assessed by facial ultrasonography
- Facial photography at screening,Overall Treatment Satisfaction according to patients close relatives and physicians,Changes in quality of life (ABCD questionnaire) after Changes.
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT01077765 |
P040601 |
LIPOPHILL |
November 2005 |
July 2008 |
September 2009 |
March 1, 2010 |
March 1, 2010 |
|
- Hopital europeen Georges Pompidou
Paris, France
|
|
| 18 |
NCT01084382 |
Unknown † |
" Arthrospira Platensis" as Nutrition Supplementation for Female Adult Patients Infected by HIV in Yaoundé Cameroon |
|
- Dietary Supplement: Arthrospira platensis
|
Interventional
|
Not Applicable |
- University of Giessen
- University of Yaounde 1
- Centre Pasteur du Cameroun
- Programme Prévention VIH-SIDA en Afrique Centrale (PPSAC): Cameroon
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Supportive Care
|
- CD4 cell account
- Individual Dietary Diversity Score (IDDS)
- Quality of life perception (WHOQOL-HIV)
- (and 3 more...)
|
70 |
Female |
18 Years to 49 Years (Adult) |
NCT01084382 |
JLU-AGKrawi_Spiru |
|
April 2010 |
June 2010 |
September 2010 |
March 10, 2010 |
March 10, 2010 |
|
- Hopital du jours
Yaounde, Centre, Cameroon - "Hôpital du jours" from the Central Hospital
Yaounde, Cameroon
|
|
| 19 |
NCT01084395 |
Completed |
Reducing HIV Risk Among Mexican Youth |
- HIV Infections
- AIDS
- Sexually Transmitted Diseases
|
- Behavioral: Adolescent Safer Sex Intervention
- Behavioral: Parent Safer Sex Communication Intervention
- Other: Adolescent Health Promotion Control Condition
- Other: Parent Health Promotion Control Condition
|
Interventional
|
Not Applicable |
- University of Michigan
- National Institute of Nursing Research (NINR)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- General Parent-Adolescent Communication
- Parent-Adolescent Sexual Risk Communication
- Comfort With Communication
- (and 2 more...)
|
1620 |
All |
Child, Adult, Older Adult |
NCT01084395 |
H03-00001528-MI
R01NR008059 |
|
September 2002 |
September 2006 |
September 2006 |
March 10, 2010 |
March 19, 2010 |
|
- Preparatory Schools
Monterrey, NL, Mexico
|
|
| 20 |
NCT01093417 |
Completed
Has Results |
Study of Vitamin D and Effect on Heart Disease and Insulin Resistance |
- Human Immunodeficiency Virus (HIV)
- Vitamin D Deficiency
- HIV Infections
|
- Drug: Vitamin D
- Other: Placebo
|
Interventional
|
Phase 2 |
- University Hospitals Cleveland Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
|
- Change in Endothelial Function
- Change in Serum 25-hydroxyvitamin D Concentration in Both Groups
|
45 |
All |
18 Years and older (Adult, Older Adult) |
NCT01093417 |
11-09-30 |
|
January 2010 |
October 2010 |
October 2010 |
March 25, 2010 |
July 14, 2016 |
February 29, 2012 |
- University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States
|
|
| 21 |
NCT01077635 |
Completed |
PENTA Fosamprenavir Study |
- Infection, Human Immunodeficiency Virus
|
- Drug: Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV)
|
Observational
|
|
- ViiV Healthcare
- GlaxoSmithKline
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number of children on licensed dose of FPV/RTV
- Reason for stopping FPV
- Laboratory tests for absolute neutrophil counts (ANC), lipids (total cholesterol [TC] and triglycerides [TG]), and alanine transaminase (ALT)
|
1 |
All |
6 Years to 18 Years (Child, Adult) |
NCT01077635 |
112880 |
|
October 2008 |
September 2011 |
September 2011 |
March 1, 2010 |
June 1, 2017 |
|
|
|
| 22 |
NCT01083810 |
Completed
Has Results |
Evaluation of Kaletra Therapy Over the Long-term |
- Human Immunodeficiency Virus
|
- Drug: Lopinavir/Ritonavir (Kaletra)
|
Observational
|
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
- Percentage of Patients With HIV-1 RNA <50 Copies/ml
- Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
- (and 3 more...)
|
284 |
All |
18 Years and older (Adult, Older Adult) |
NCT01083810 |
KAL 1 RO |
|
June 2001 |
June 2010 |
June 2010 |
March 10, 2010 |
August 11, 2011 |
July 29, 2011 |
- Site Ref # / Investigator 27706
Aachen, Germany - Site Ref # / Investigator 52972
Aachen, Germany - Site Ref # / Investigator 27660
Berlin, Germany - (and 87 more...)
|
|
| 23 |
NCT01097655 |
Completed
Has Results |
Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet |
- Human Immunodeficiency Virus
|
|
Observational
|
|
- AbbVie (prior sponsor, Abbott)
- Veeda Clinical Research
- AbbVie
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
- Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
|
3049 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT01097655 |
P06-131 |
|
August 2006 |
January 2016 |
January 2016 |
April 2, 2010 |
May 23, 2017 |
May 23, 2017 |
|
|
| 24 |
NCT01076179 |
Completed
Has Results |
Kaletra in Combination With Antiretroviral Agents |
- Human Immunodeficiency Virus
|
|
Observational
|
|
- AbbVie (prior sponsor, Abbott)
- AbbVie
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Prevalence of Adverse Events (Weeks 0-144), Per Event
- Prevalence of Adverse Events (Weeks 0-144), Per Participant
- Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
- (and 15 more...)
|
502 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT01076179 |
P11-021 |
PROTEKT |
September 2008 |
January 2016 |
January 2016 |
February 26, 2010 |
May 19, 2017 |
May 19, 2017 |
|
|
| 25 |
NCT01078233 |
Completed
Has Results |
Observational Data Analysis in EuroSIDA (MK-0518-058) |
|
|
Observational
|
|
- Merck Sharp & Dohme Corp.
- EuroSIDA Coordinating Centre, Copenhagen HIV Programme (CHIP)
|
Industry / Other |
- Observational Model: Cohort
- Time Perspective: Other
|
- Incidence of Malignancy
- Incidence of Clinically Important Hepatic Events
- Incidence of Lipodystrophy
- Incidence of All-Cause Mortality
|
6617 |
All |
16 Years and older (Child, Adult, Older Adult) |
NCT01078233 |
0518-058
2010_020
EP08025.005 |
|
May 5, 2008 |
March 6, 2014 |
March 6, 2014 |
March 2, 2010 |
July 11, 2017 |
September 17, 2015 |
|
|
| 26 |
NCT01098526 |
Completed |
GSK1349572 Drug Interaction Study With Efavirenz |
- Infections, Human Immunodeficiency Virus and Herpesviridae
|
- Drug: GSK1349572
- Drug: Efavirenz
|
Interventional
|
Phase 1 |
- ViiV Healthcare
- Shionogi
- GlaxoSmithKline
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Plasma GSK1349572 PK parameters: AUC (0-24)
- Plasma GSK1349572 PK parameters: Cmax
- Plasma GSK1349572 PK parameters: C24
- (and 12 more...)
|
12 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01098526 |
114005 |
|
March 16, 2010 |
May 26, 2010 |
May 26, 2010 |
April 2, 2010 |
September 25, 2017 |
|
- GSK Investigational Site
Buffalo, New York, United States
|
|
| 27 |
NCT01089114 |
Completed |
Cardiovascular Radiologic and Metabolic Assessment in HIV: An Investigation of Pathophysiology |
- HIV
- Cardiovascular Disease
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
- Intramyocardial triglyceride
|
168 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT01089114 |
100080
10-I-0080 |
|
March 8, 2010 |
|
August 7, 2015 |
March 18, 2010 |
February 14, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 28 |
NCT01137981 |
Recruiting |
Antiretroviral Pregnancy Registry (APR)-Risk of Birth Defects |
- Infection, Human Immunodeficiency Virus
|
- Drug: Any Antiretroviral Therapy
|
Observational
|
|
- ViiV Healthcare
- GlaxoSmithKline
|
Industry |
- Observational Model: Other
- Time Perspective: Prospective
|
- A birth defect is defined as any congenital malformations according to modified (by APR) classification of Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP) criteria
|
1 |
Female |
Child, Adult, Older Adult |
NCT01137981 |
112885
WE066 (EPIP095)
EPI40018 |
|
February 15, 1993 |
December 31, 2024 |
December 31, 2024 |
June 7, 2010 |
October 24, 2017 |
|
- GSK Investigational Site
Wilmington, North Carolina, United States
|
|
| 29 |
NCT01153269 |
Completed
Has Results |
Long-term Effectiveness and Safety in Hepatitis-co-infected Patients |
- Human Immunodeficiency Virus-Infection
|
- Drug: Lopinavir/Ritonavir (Kaletra)
|
Observational
|
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
- Viral Load
- CD4 Cell Count
|
33 |
All |
18 Years and older (Adult, Older Adult) |
NCT01153269 |
KAL 1 HO |
|
May 2001 |
November 2010 |
November 2010 |
June 30, 2010 |
December 19, 2011 |
December 19, 2011 |
- Site Reference ID/Investigator# 27575
Berlin, Germany - Site Reference ID/Investigator# 27592
Berlin, Germany - Site Reference ID/Investigator# 27588
Dortmund, Germany - (and 5 more...)
|
|
| 30 |
NCT01077960 |
Completed
Has Results |
Safety and Efficacy Study of Serostim® Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome |
- Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome
|
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change From Baseline to Week 12 in Trunk Fat as Assessed by Dual-Energy X-Ray Absorptiometry (DXA) Scan
- Change From Baseline to Week 12 in Waist Circumference
- Change From Baseline to Week 12 in Insulin-like Growth Factor I
- (and 3 more...)
|
126 |
All |
18 Years and older (Adult, Older Adult) |
NCT01077960 |
25373 (NCT01077960) |
|
February 2005 |
January 2006 |
January 2006 |
March 1, 2010 |
August 7, 2013 |
June 23, 2010 |
- University of Alabama/Birmingham
Birmingham, Alabama, United States - Care Clinic
Los Angeles, California, United States - Private Practice
Palm Beach, California, United States - (and 23 more...)
|
|
| 31 |
NCT01084343 |
Completed |
Investigation of the Safety of an HIV-1 Vaccine Given Intra-muscularly and Intra-nasally to Healthy Female Subjects |
|
|
Interventional
|
Phase 1 |
- Mymetics Corporation
- Kinesis Pharma
- CEVAC
- (and 8 more...)
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Adverse events (local and systemic)
- Humoral immune response (in blood)
|
24 |
Female |
18 Years to 45 Years (Adult) |
NCT01084343 |
MYM-V101-CT08-101
2008-007306-10 |
|
November 2009 |
September 2010 |
September 2010 |
March 10, 2010 |
July 13, 2012 |
|
|
|
| 32 |
NCT01097070 |
Completed |
A Phase 2 Study to Assess the Pharmacokinetics of Bevirimat 100 mg Tablets Given to HIV-1 Positive Patient for 15 Days |
|
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Measure bevirimat blood plasma concentrations to calculate the pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life when bevirimat is administered as 2 x 100 mg tablets BID, 3 X 100 mg tablets QD, 4 X 100 mg tablets QD for 15 days
- Measure bevirimat blood plasma concentrations following the administration of bevirimat 2 X 100 mg, 3 x 100 mg, or 4 x 100 mg tablets after a standardized meal. The pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life will be calculated.
|
35 |
All |
18 Years and older (Adult, Older Adult) |
NCT01097070 |
Bevirimat Study 206 |
|
November 2008 |
January 2009 |
January 2009 |
April 1, 2010 |
April 1, 2010 |
|
- Quest Clinical Research
San Francisco, California, United States - Gary J. Richmond, MD, PA
Ft. Lauderdale, Florida, United States - AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States - Community Research Initiative of New England
Boston, Massachusetts, United States
|
|
| 33 |
NCT01092104 |
Completed |
A Proof of Concept Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of the CCR5 Antagonist TBR 652 in HIV 1-Infected, Antiretroviral Treatment-Experienced, CCR5 Antagonist-Naïve Patients |
|
- Drug: TBR-652
- Drug: TBR-652 Matching Placebo
- Drug: TBR-652 50 mg
- (and 3 more...)
|
Interventional
|
Phase 1
Phase 2 |
- Tobira Therapeutics, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- HIV-1 RNA Change from Baseline
|
52 |
All |
18 Years and older (Adult, Older Adult) |
NCT01092104 |
652-2-201 |
|
February 2009 |
November 2009 |
November 2009 |
March 24, 2010 |
July 10, 2013 |
|
|
|
| 34 |
NCT01077557 |
Completed |
Fractures Stratified by HIV and Antiretroviral Therapy (ART) Status |
- Fracture
- Infection, Human Immunodeficiency Virus
|
- Other: No Antiretroviral (ARV) Drug Exposure
- Drug: Any Antiretroviral (ARV) Drug Exposure
|
Observational
|
|
- ViiV Healthcare
- GlaxoSmithKline
|
Industry |
- Observational Model: Case-Control
- Time Perspective: Retrospective
|
- Incident fracture defined by first ICD-9-CM code 733.1 or 800-829 during the follow-up period. Inclusion is restricted to four-digit codes for closed fracture. Exclusions will be codes for skull, face, chest, rib, open fracture, and crushing injuries
|
1 |
All |
18 Years and older (Adult, Older Adult) |
NCT01077557 |
111950 |
|
November 2006 |
November 2011 |
November 2011 |
March 1, 2010 |
June 1, 2017 |
|
|
|
| 35 |
NCT01086878 |
Completed |
Safety of Cotrimoxazole in HIV- and HAART-exposed Infants |
- Acquired Immunodeficiency Syndrome
- Infant, Newborn
- Anemia
- (and 2 more...)
|
|
Interventional
|
Phase 4 |
- Harvard School of Public Health
- National Institute of Allergy and Infectious Diseases (NIAID)
- John E. Fogarty International Center (FIC)
- (and 2 more...)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- incidence of severe or life-threatening anemia
- incidence of severe or life-threatening neutropenia
- composite severe morbidity and mortality
|
222 |
All |
Child, Adult, Older Adult |
NCT01086878 |
BHP031
2P30AI060354-06
3R24TW007988-01S1 |
|
February 2009 |
October 2010 |
October 2010 |
March 15, 2010 |
February 25, 2011 |
|
- Scottish Livingstone Hospital
Molepolole, Kweneng, Botswana - Princess Marina Hospital
Gaborone, Botswana
|
|
| 36 |
NCT01084421 |
Completed |
A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos |
|
- Behavioral: Computer-based parent-adolescent HIV communication
|
Interventional
|
Not Applicable |
- University of Michigan
- National Institute of Nursing Research (NINR)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- general parent-adolescent communication, parent-adolescent sexual risk communication, comfort with communication
|
260 |
All |
Child, Adult, Older Adult |
NCT01084421 |
HUM00020148
R21NR010457 |
|
September 2007 |
September 2008 |
June 2010 |
March 10, 2010 |
August 31, 2016 |
|
- Detroit Hispanic Development Corporation (DHDC)
Detroit, Michigan, United States
|
|
| 37 |
NCT01090102 |
Completed
Has Results |
Mesalamine to Reduce T Cell Activation in HIV Infection |
- HIV Infections
- Sexually Transmitted Diseases
- Immune System Diseases
- (and 2 more...)
|
- Drug: Mesalamine (5-aminosalicylic acid, Apriso)
- Drug: Placebo
|
Interventional
|
Phase 4 |
- University of California, San Francisco
- California HIV/AIDS Research Program
- Valeant Pharmaceuticals International, Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells During the First 12 Weeks of Study
- Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells After Treatment Crossover
|
33 |
All |
18 Years and older (Adult, Older Adult) |
NCT01090102 |
164320 |
|
June 2010 |
December 2012 |
December 2012 |
March 19, 2010 |
August 13, 2014 |
August 11, 2014 |
- University of California, San Francisco-San Francisco General Hospital
San Francisco, California, United States
|
|
| 38 |
NCT01092611 |
Completed |
Long-term Follow-up of Participants From Studies Evaluating GSK HIV Vaccine |
|
- Procedure: Blood collection
- Biological: GSK HIV vaccine 732462
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification)
- CD4 count
- Viral load (VL) and method of measurement
- (and 14 more...)
|
190 |
All |
18 Years to 55 Years (Adult) |
NCT01092611 |
114083
2009-018097-64 |
|
March 22, 2010 |
March 17, 2014 |
May 19, 2014 |
March 25, 2010 |
March 2, 2018 |
|
- GSK Investigational Site
Bakersfield, California, United States - GSK Investigational Site
Fort Lauderdale, Florida, United States - GSK Investigational Site
Orlando, Florida, United States - (and 38 more...)
|
|
| 39 |
NCT01092182 |
Active, not recruiting |
Phase II Study of Dose-Adjusted EPOCH-Rituximab in Adults With Untreated Burkitt Lymphoma and c-MYC+ Diffuse Large B-Cell Lymphoma |
- Burkitt Lymphoma
- Diffuse Large B-cell Lymphoma, c-MYC Positive
- Plasmablastic Lymphoma
|
- Drug: EPOCH-R
- Drug: EPOCH-RR
|
Interventional
|
Phase 2 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
194 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT01092182 |
100052
10-C-0052 |
|
February 24, 2010 |
February 28, 2021 |
February 28, 2023 |
March 24, 2010 |
May 18, 2018 |
|
- Mercy Medical Center-Sioux City
Sioux City, Iowa, United States - Saint Luke's Regional Medical Center
Sioux City, Iowa, United States - Siouxland Hematology Oncology Associates LLP
Sioux City, Iowa, United States - (and 29 more...)
|
|
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