1 |
NCT01437475 |
Unknown † |
Efficiency of the Hepatitis B Sci-B-Vac Vaccine in HIV Positive Patients |
|
|
Interventional |
Not Applicable |
- Tel-Aviv Sourasky Medical Center
- SciGen, Israel
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- HBV immunization rate after 1, 2 and 3rd dose of Sci-B-Vac
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT01437475 |
TASMC-11-DA-0277-CITL |
|
November 2011 |
March 2013 |
November 2013 |
September 21, 2011 |
October 6, 2011 |
|
- Dan Turner
Tel Aviv, Israel
|
2 |
NCT01441193 |
Terminated |
A Phase I Safety and Immunogenicity Preventive Vaccine Trial Based on the HIV-1 Tat and V2-deleted Env Proteins (ISS P-002) |
|
- Biological: HIV-1 Tat/delta-V2 Env combined vaccine
- Biological: HIV-1 delta-V2 Env vaccine
- Biological: HIV-1 Tat vaccine 7.5 microg
- Biological: HIV-1 Tat vaccine 30 microg
|
Interventional |
Phase 1 |
- Barbara Ensoli, MD
- Novartis Vaccines
- Istituto Superiore di Sanità
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Safety and immunogenicity
|
11 |
All |
18 Years to 55 Years (Adult) |
NCT01441193 |
ISS P-002 |
|
September 2011 |
February 2014 |
February 2014 |
September 27, 2011 |
March 4, 2016 |
|
- Policlinico di Modena, Divisione di Malattie Infettive
Modena, Italy - Azienda Ospedaliera San Gerardo, Divisione di Malattie Infettive
Monza, Italy - IFO - S. Gallicano, Dermatologia Infettiva
Rome, Italy
|
3 |
NCT01475890 |
Completed |
Vitamin D Supplementation in HIV |
|
- Dietary Supplement: Vitamin D3
- Dietary Supplement: Placebo
|
Interventional |
Phase 2 Phase 3 |
- 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
|
- Vitamin D Supplementation Safety
|
58 |
All |
5 Years to 24 Years (Child, Adult) |
NCT01475890 |
11-008093 5R01AT005531-02 |
|
July 2011 |
June 2013 |
February 2017 |
November 22, 2011 |
March 17, 2017 |
|
- Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
|
4 |
NCT01433289 |
Unknown † |
Study to Evaluate Safety and Toxicity of Polyphenon E (EGCG) in HIV-1-Infected Individuals |
|
|
Interventional |
Phase 1 |
- Baylor College of Medicine
- National Center for Complementary and Integrative Health (NCCIH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of Participants with Adverse Events
- Median change of log10 HIV-1 RNA
- Proportion of participants achieving > 0.75 or 1.0 log10 reduction in HIV-1 RNA or <400 copies/ml
- (and 2 more...)
|
24 |
All |
18 Years to 65 Years (Adult) |
NCT01433289 |
H-21490 R21AT004673 |
|
December 2010 |
August 2014 |
July 2015 |
September 13, 2011 |
February 3, 2015 |
|
- Baylor College of Medicine
Houston, Texas, United States - University of Texas Health Science Center Houston
Houston, Texas, United States
|
5 |
NCT01438606 |
Completed |
Evaluating the Safety of and Immune Response to the VSV-Indiana HIV Vaccine in Healthy, HIV-Uninfected Adults |
|
- Biological: VSV-Indiana HIV gag vaccine
- Biological: Placebo injection (normal saline)
|
Interventional |
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Change in frequency and severity of local injection site reactogenicity signs and symptoms
- Frequency of adverse events (AEs) categorized by Medical Dictionary for Regulatory Activities (MedDRA) body system
- Change in distribution of values of safety laboratory measures
- (and 5 more...)
|
60 |
All |
18 Years to 50 Years (Adult) |
NCT01438606 |
HVTN 090 11669 |
|
October 2011 |
January 2013 |
|
September 22, 2011 |
June 14, 2016 |
|
- Bridge HIV CRS
San Francisco, California, United States - The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, United States - Penn Prevention CRS
Philadelphia, Pennsylvania, United States - Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, United States
|
6 |
NCT01435135 |
Active, not recruiting |
Study of Late Boost Strategies for HIV-uninfected Participants From Protocol RV 144 |
|
- Biological: ALVAC-HIV
- Biological: AIDSVAX B/E
- Biological: ALVAC-HIV Placebo
- Biological: AIDSVAX B/E Placebo
|
Interventional |
Phase 2 |
- U.S. Army Medical Research and Materiel Command
- National Institutes of Health (NIH)
|
U.S. Fed / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Primary Immunogenicity Endpoint
- Safety Endpoints
- Secondary Immunogenicity Endpoints
|
162 |
All |
18 Years and older (Adult, Senior) |
NCT01435135 |
RV 305 WRAIR #1792 A-14430.13 S-10-0010 |
|
April 2012 |
December 2017 |
December 2018 |
September 15, 2011 |
October 12, 2017 |
|
- Bang Lamung District Hospital
Chon Buri, Thailand - Phan Thong District Hospital
Chon Buri, Thailand
|
7 |
NCT01440569 |
Completed Has Results |
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults |
- Acquired Immunodeficiency Syndrome
- HIV Infections
|
- Drug: COBI
- Drug: DRV
- Drug: NRTIs
|
Interventional |
Phase 3 |
- Gilead Sciences
- Janssen Research & Development, LLC
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24
- Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24 (Snapshot Analysis)
- Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (Snapshot Analysis)
- (and 4 more...)
|
314 |
All |
18 Years and older (Adult, Senior) |
NCT01440569 |
GS-US-216-0130 2011-003501-22 |
|
September 2011 |
August 2012 |
October 2015 |
September 26, 2011 |
December 14, 2016 |
October 28, 2014 |
- Spectrum Medical Group
Phoenix, Arizona, United States - Long Beach Education and Research Consultants, PC
Long Beach, California, United States - Peter J Ruane MD Inc.
Los Angeles, California, United States - (and 46 more...)
|
8 |
NCT01434706 |
Unknown † |
Implementation of Nucleic Acid Amplification Testing Screening to Identify Acute and Early HIV Infection |
|
- Other: Nucleic Acid Amplification Testing
|
Interventional |
Phase 3 |
- University of California, San Diego
- National Institutes of Health (NIH)
- Centers for Disease Control and Prevention
|
Other / NIH / U.S. Fed |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Nucleic Acid Amplification Testing
|
12000 |
All |
13 Years and older (Child, Adult, Senior) |
NCT01434706 |
10-1414 |
|
December 2006 |
June 2017 |
June 2017 |
September 15, 2011 |
December 4, 2014 |
|
- Christie's Place
San Diego, California, United States - San Diego LGBT Community Center
San Diego, California, United States - UC San Diego Antiviral Research Center
San Diego, California, United States - (and 2 more...)
|
9 |
NCT01433185 |
Completed |
Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV |
- HIV Infections
- Acquired Immunodeficiency Syndrome
|
|
Interventional |
Not Applicable |
- University of Washington
- Kenya Medical Research Institute
- University of California, San Francisco
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Proportion of women who attend postnatal clinic within 6-8 weeks postpartum
- Proportion of infants tested for HIV by DNA PCR
- Infant adherence to antiretroviral prophylaxis
- (and 2 more...)
|
388 |
Female |
18 Years and older (Adult, Senior) |
NCT01433185 |
41186-E/G |
SMS4PMTCT |
April 2012 |
July 2013 |
July 2013 |
September 13, 2011 |
January 21, 2015 |
|
- Kenya Medical Research Institute, Family AIDS Care and Education Services
Kisumu, Nyanza, Kenya
|
10 |
NCT01450189 |
Completed Has Results |
A Key Link for Transmission Prevention |
|
- Behavioral: Standard HIV prevention messages
- Behavioral: BI: Information-Motivation-Behavioral Skills Model
- Drug: Raltegravir
- Drug: emtricitabine/tenofovir disoproxil fumarate
|
Interventional |
Not Applicable |
- University of North Carolina, Chapel Hill
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening
- Prevalence of AHI Among Persons Screened
- Proportion of Persons With AHI Successfully Recruited Into the Study
- (and 25 more...)
|
46 |
All |
18 Years to 65 Years (Adult) |
NCT01450189 |
11-0815 CID 1002 |
MP3 |
October 2011 |
July 2014 |
July 2014 |
October 12, 2011 |
April 19, 2018 |
May 12, 2016 |
- Lighthouse Trust, Kamuzu Central Hospital
Lilongwe, Malawi - UNC Project
Lilongwe, Malawi
|
11 |
NCT01439841 |
Completed |
The Effect of Probiotics in HIV-1 Infection |
|
- Dietary Supplement: Multi-strain probiotic
- Dietary Supplement: Placebo
|
Interventional |
Not Applicable |
- Oslo University Hospital
- Karolinska University Hospital
- Tine
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Safety
- Changes in measures of microbial translocation
- Changes in markers of immune activation
- (and 3 more...)
|
32 |
All |
18 Years and older (Adult, Senior) |
NCT01439841 |
ProGut1.0 |
ProGut |
October 2011 |
April 2013 |
June 2013 |
September 23, 2011 |
September 28, 2017 |
|
- Oslo University Hospital
Oslo, Norway - Karolinska University Hospital Huddinge
Stockholm, Sweden
|
12 |
NCT01433796 |
Completed |
Screening for Tuberculosis in HIV-infected Patients Eligible for Antiretroviral Treatment |
- HIV Infection
- Tuberculosis
|
|
Observational |
|
- Lund University
- Swedish International Development Cooperation Agency (SIDA)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Correlation between baseline clinical characteristics and presence of microbiologically confirmed active tuberculosis.
- Comparison of ART outcome in patients taking concomitant anti-tuberculosis therapy and those only taking ART.
- Comparison of diagnostic methods for detection of TB among HIV-infected subjects eligible to start ART.
|
812 |
All |
18 Years and older (Adult, Senior) |
NCT01433796 |
LU-2010/672 3120/215/03 |
|
October 2011 |
May 2013 |
December 2015 |
September 14, 2011 |
March 8, 2016 |
|
- Adama Health Centre
Adama, Oromia, Ethiopia - Geda Health Centre
Adama, Oromia, Ethiopia - Dhera Health Center
Dhera, Oromia, Ethiopia - (and 2 more...)
|
13 |
NCT01433601 |
Unknown † |
Antiretroviral Treatment Strategies in Relation to Adherence, Resistance and Virological Treatment Failure |
- Human Immunodeficiency Virus (HIV)
|
- Behavioral: Enhanced Treatment Support (ETS)
|
Interventional |
Not Applicable |
- Karolinska Institutet
- Hanoi Medical University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Virological treatment failure
- Immunological treatment failure
- Clinical treatment failure
|
640 |
All |
18 Years to 59 Years (Adult) |
NCT01433601 |
DotArv_Vietnam |
DotArv |
August 2007 |
November 2011 |
November 2011 |
September 14, 2011 |
September 14, 2011 |
|
- Hanoi Medical University
Hanoi, Vietnam
|
14 |
NCT01448486 |
Terminated Has Results |
A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV |
- Human Immunodeficiency Virus (HIV)
- HIV Associated Neurocognitive Disorders (HAND)
|
|
Interventional |
Phase 4 |
- St Vincent's Hospital, Sydney
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Neurocognitive Function
- Cerebrospinal Fluid
|
6 |
All |
18 Years and older (Adult, Senior) |
NCT01448486 |
11/033 IISP 37693 |
HANDral |
October 2011 |
October 2013 |
October 2013 |
October 7, 2011 |
June 27, 2016 |
January 3, 2014 |
- St. Vincent's Hospital
Sydney, New South Wales, Australia - The Alfred Hospital
Melbourne, Victoria, Australia
|
15 |
NCT01449006 |
Completed Has Results |
A Study of the Neurological Effects of Adding Maraviroc to HAART Regimen in Patients With HIV (HANDmac) |
- Human Immunodeficiency Virus (HIV)
- HIV Associated Neurocognitive Disorders (HAND)
|
|
Interventional |
Phase 4 |
- Bruce Brew
- ViiV Healthcare
- St Vincent's Hospital, Sydney
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Neurocognitive Functioning
- Change in CSF Neopterin Concentration
- Change in MRS Cerebral Metabolite Ratios in Basal Ganglia
- Change in MRS Cerebral Metabolite Ratios in Frontal White Matter
|
19 |
All |
18 Years and older (Adult, Senior) |
NCT01449006 |
11/066 114560 |
HANDmac |
October 2011 |
September 2014 |
September 2014 |
October 7, 2011 |
May 20, 2016 |
May 20, 2016 |
- St. Vincent's Hospital
Sydney, New South Wales, Australia - The Alfred Hospital
Melbourne, Victoria, Australia
|
16 |
NCT01444690 |
Unknown † |
Dimiracetam in Painful Neuropathies Affecting AIDS Patients |
- Acquired Immunodeficiency Syndrome
|
- Drug: Dimiracetam
- Drug: Dimiracetam 25 mg
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Pain intensity measured on 100 mm VAS
- Pain intensity as measured with Total Symptom Score (TSS)
- Adverse events
- (and 3 more...)
|
244 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01444690 |
NT-004-DIPANAP |
DIPANAP |
January 2012 |
January 2013 |
January 2013 |
October 3, 2011 |
October 3, 2011 |
|
- Neurotune AG
Lugano, Switzerland
|
17 |
NCT01434654 |
Terminated Has Results |
Efficacy of Neuro-HAART in Patients With HIV |
|
|
Observational |
|
- St Vincent's Hospital, Sydney
- ViiV Healthcare
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in Neurocognitive Functioning
- Change in MRS Cerebral Metabolite Ratios in Basal Ganglia
- Change in MRS Cerebral Metabolite Ratios in Frontal White Matter
- Cerebrospinal Fluid
|
19 |
All |
18 Years and older (Adult, Senior) |
NCT01434654 |
09/192 COL114560 |
HANDobs |
September 2011 |
September 2014 |
September 2014 |
September 15, 2011 |
August 9, 2016 |
May 20, 2016 |
- St Vincent's Hospital
Sydney, New South Wales, Australia - The Alfred Hospital
Prahran, Victoria, Australia
|
18 |
NCT01445223 |
Completed |
A Study on Antiretroviral Therapy (ART) Naïve Patients On Different Regimens to Treat Hiv (NORTHIV) |
|
- Drug: Lopinavir ritonavir
- Drug: Atazanavir ritonavir
- Drug: Efavirenz
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Intention to treat (ITT)/time to loss of virological response (TLOVR)
- Frequency of abnormal laboratory parameters
- Adherence to study medication
- (and 4 more...)
|
242 |
All |
16 Years and older (Child, Adult, Senior) |
NCT01445223 |
Northiv protocol 3.66 |
|
April 2004 |
December 2009 |
December 2009 |
October 3, 2011 |
October 4, 2011 |
|
- Department of Infectious Diseases
Goteborg, Sweden
|
19 |
NCT01448915 |
Active, not recruiting |
Management of Hepatitis C in HIV Infected Injection Drug Users (IDUs) |
|
|
Observational |
|
- Johns Hopkins University
- National Institute on Drug Abuse (NIDA)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Hepatitis C Treatment Uptake and HCV cure
- Incidence of clinical outcomes in persons with HIV/HCV coinfection with or without HCV cure
- Liver stiffness measurement by elastography in persons with HIV infection
|
1000 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT01448915 |
NA00029706 R01DA016065 |
|
September 2009 |
March 2019 |
March 2019 |
October 7, 2011 |
August 21, 2017 |
|
- Johns Hopkins Hospital
Baltimore, Maryland, United States
|
20 |
NCT01450059 |
Completed |
Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section |
- Human Immunodeficiency Virus
|
|
Observational |
|
- Johann Wolfgang Goethe University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Maternal CD4+ t-cells in HiV exposed Newborns
- HiV transmission rate
- Analysis of HiV in maternal CD4+ t-cells
- Measurement of maternal CD8+ t-cells in the Newborn
|
54 |
All |
up to 10 Minutes (Child) |
NCT01450059 |
31082011 FRA Mat Fet Chim |
|
August 2011 |
April 2014 |
August 2015 |
October 12, 2011 |
February 22, 2016 |
|
- Clinic of the Johann Wolfgang-Goethe Univeristy
Frankfurt/Main, Hesse, Germany
|
21 |
NCT01452555 |
Unknown † |
Video-Based Delivery of HIV Test Information for Spanish-Speaking Latinos |
|
- Behavioral: Video or In-Person Presentation
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Effectiveness of an educational video regarding HIV and HIV testing for Spanish speaking Latinos
|
200 |
All |
18 Years to 64 Years (Adult) |
NCT01452555 |
1R21NR011997 |
|
August 2011 |
|
|
October 17, 2011 |
October 17, 2011 |
|
- Rhode Island Hospital
Providence, Rhode Island, United States
|
22 |
NCT01434628 |
Completed |
Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Non-Surgical Circumcision When Performed by Nurses |
- Male Circumcision
- HIV Prevention
|
|
Interventional |
Not Applicable |
- Ministry of Health, Rwanda
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- To assess the safety of the PrePex device when circumcision is performed by nurses
- Evaluating the cost of PrePex circumcision procedure
- To evaluate the PrePex training needs
- Assessing ideal messaging for scale up sensitization, to include:
|
590 |
Male |
21 Years to 54 Years (Adult) |
NCT01434628 |
RMC-03 |
|
July 2011 |
November 2011 |
December 2011 |
September 15, 2011 |
May 23, 2014 |
|
- Kanombe Military Hospital
Kigali, Rwanda
|
23 |
NCT01456962 |
Completed Has Results |
Influence of Antiretroviral Regimen on Immune Reconstitution in the Female Genital Tract |
- Women's Health
- HIV Infection
- Genital Diseases, Female
|
|
Observational |
|
- University of Colorado, Denver
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- CD4+ to CD8+ T Cell Ratio in Cervical Biopsies
|
36 |
Female |
18 Years to 80 Years (Adult, Senior) |
NCT01456962 |
11-1265 39423 |
|
October 2011 |
August 2013 |
August 2013 |
October 21, 2011 |
June 9, 2017 |
June 12, 2015 |
- University of Colorado
Aurora, Colorado, United States
|
24 |
NCT01450618 |
Completed |
Comparative Tolerability of Protease Inhibitors |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Percent of patients.with new onset GI symptoms after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen
- Percent of patients with new onset lipid abnormalities or new onset jaundice (separately) after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen
- Healthcare utilization
- Healthcare costs
|
26000 |
All |
18 Years to 64 Years (Adult) |
NCT01450618 |
AI424-435 |
|
March 2011 |
November 2011 |
October 2012 |
October 12, 2011 |
December 5, 2012 |
|
|
25 |
NCT01449929 |
Completed Has Results |
Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects |
- Infection, Human Immunodeficiency Virus
|
- Drug: dolutegravir 50 mg OAD
- Drug: darunavir 800mg OAD
- Drug: ritonavir 100mg OAD
|
Interventional |
Phase 3 |
- ViiV Healthcare
- GlaxoSmithKline
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48
- Time to Virologic Suppression (<50 Copies/mL) Through Week 48
- Percentage of Participants With Plasma HIV-1 RNA <400 c/mL at Week 48
- (and 13 more...)
|
488 |
All |
18 Years and older (Adult, Senior) |
NCT01449929 |
114915 |
FLAMINGO |
October 31, 2011 |
April 22, 2013 |
December 26, 2016 |
October 10, 2011 |
January 16, 2018 |
March 27, 2014 |
- GSK Investigational Site
Birmingham, Alabama, United States - GSK Investigational Site
Los Angeles, California, United States - GSK Investigational Site
Los Angeles, California, United States - (and 63 more...)
|
26 |
NCT01448512 |
Completed |
Promoting Male Involvement to Improve Prevention of Mother to Child Transmission (PMTCT) Uptake and Reduce Antenatal Infection |
|
- Behavioral: PartnerPlus Intervention
- Other: Usual Care
|
Interventional |
Not Applicable |
- University of Miami
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Change in number of ANC visits by mother and father from baseline to one month post intervention to 32 weeks to 3 days post partum
- Change in Mother, father, infant HIV VCT from baseline to one month to 3 days post partum
- Mother and infant ARV prophylaxis
- (and 3 more...)
|
478 |
All |
18 Years and older (Adult, Senior) |
NCT01448512 |
5P30AI073961-S P30AI073961 |
|
September 2010 |
August 2012 |
August 2012 |
October 7, 2011 |
January 22, 2014 |
|
- Human Sciences Research Council
Pretoria, Gauteng, South Africa
|
27 |
NCT01443117 |
Withdrawn |
Evaluating the Safety and Immune Response to Two Pneumococcal Vaccines in HIV-Infected Pregnant Women |
- Pneumococcal Infections
- HIV Infections
|
- Biological: PPV-23 Vaccine
- Biological: PCV-13 Vaccine
- Biological: Placebo Vaccine
|
Interventional |
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- For women: Grade 3 or higher adverse events
- For women: Grade 3 or higher adverse events judged to be at least possibly related to the study treatment
- For women: A 2-fold increase in ELISA or 4-fold rise in opsonic activity (OPA)-measured antibody concentrations
- (and 10 more...)
|
0 |
Female |
13 Years to 39 Years (Child, Adult) |
NCT01443117 |
P1091 11687 |
|
|
August 2014 |
|
September 29, 2011 |
May 7, 2014 |
|
|
28 |
NCT01434563 |
Completed |
The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort - |
- HIV-1-Associated Cognitive Motor Complex
|
|
Observational |
|
- Holdsworth House Medical Practice
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The primary outcome measure is percentage of patients with abnormal (-1.5 SD in 2 domains) CogState battery in HIV positive patients vs HIV negative patients.
|
326 |
All |
18 Years and older (Adult, Senior) |
NCT01434563 |
CNS HAND Study |
CNS HAND |
October 2011 |
October 2012 |
October 2012 |
September 15, 2011 |
October 24, 2012 |
|
|
29 |
NCT01437241 |
Completed |
Etravirine Plus 2 Analogs in HIV-infected Patients |
|
|
Observational |
|
- Hospitales Universitarios Virgen del Rocío
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Virological efficacy
- Safety
|
175 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01437241 |
LFL-ETR-2010-01 |
|
January 2009 |
July 2011 |
September 2011 |
September 20, 2011 |
November 1, 2011 |
|
- Hospital La Linea de la Concepción
La Linea de la Concepción, Cadiz, Spain - Hospital Universitario Puerto Real
Puerto Real, Cadiz, Spain - Hospital Costa del Sol
Marbella, Malaga, Spain - (and 8 more...)
|
30 |
NCT01447680 |
Completed |
Comparison of Plasma & SMARTplasma for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) Antibody Testing |
- Human Immunodeficiency Virus Infection
- Hepatitis C
|
|
Observational |
|
- G & W Laboratories Inc.
- Alquest
- SMART Biotech Ltd
|
Industry / Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Concordance of positive and negative results between normal and treated plasma samples when both are tested with the same HIV and/or HCV Enzyme Linked Immunosorbant Assay (ELISA)
- Sensitivity and specificity of HIV and HCV antibody assays when used with SMARTplasma
- Correlation of results from two different sample types (heparin vs EDTA)
- Correlation of results from refrigerated versus frozen then thawed samples
|
1600 |
All |
18 Years to 64 Years (Adult) |
NCT01447680 |
ST-2011-HIV, Version 4 |
|
August 2011 |
December 2012 |
December 2012 |
October 6, 2011 |
September 7, 2015 |
|
- Therafirst Medical Centers
Fort Lauderdale, Florida, United States - American Red Cross
Douglasville, Georgia, United States - Evelyn Jordan Center
Baltimore, Maryland, United States - (and 4 more...)
|
31 |
NCT01443923 |
Terminated Has Results |
Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV |
|
- Drug: Boceprevir
- Drug: Peg-Interferon-alfa 2B
- Drug: Ribavirin
|
Interventional |
Phase 4 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Efficacy, Defined as Sustained Viral Response (SVR) Six Months After the End of Specified Treatment.
- Change in Early HCV Viral Load Kinetics Between Mono and Co-infected Subjects
- Safety and Treatment Outcome Measures Stratified by ESA Use
- (and 2 more...)
|
4 |
All |
18 Years and older (Adult, Senior) |
NCT01443923 |
110253 11-I-0253 |
|
September 2011 |
September 2013 |
September 2013 |
September 30, 2011 |
July 13, 2015 |
July 13, 2015 |
- Unity Health Care, Inc./DC General
Washington, DC, District of Columbia, United States - National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
32 |
NCT01445145 |
Completed |
An Exploratory Study of the Use of Five Wishes as a Tool for Advanced Care Planning in Young Adults With Metastatic, Recurrent, or Progressive Cancer or HIV Infection |
|
|
Observational |
|
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Time Perspective: Prospective
|
|
70 |
All |
16 Years to 30 Years (Child, Adult) |
NCT01445145 |
070085 07-C-0085 |
|
January 26, 2007 |
|
September 25, 2014 |
October 3, 2011 |
April 20, 2018 |
|
- Georgetown University
Washington, District of Columbia, United States - National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
33 |
NCT01453192 |
Completed |
Renal Transplantation and Raltegravir in HIV-Infected Patients |
- HIV-1 Infection
- Chronic Renal Insufficiency
|
|
Interventional |
Phase 3 |
- French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of acute clinical renal graft rejection
- Incidence of acute clinical and subclinical renal graft rejection
- One year graft survival
- (and 8 more...)
|
27 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01453192 |
2011-001004-35 ANRS 153 TREVE |
ANRS153TREVE |
December 2011 |
November 2015 |
November 2015 |
October 17, 2011 |
July 12, 2016 |
|
- Hôpital Pellegrin, Service de Nephrologie, Transplantation Rénale, Dialyse
Bordeaux, France - CHU De Caen, Service de Néphrologie Hémodialyse
Caen, France - Hôpital Henri Mondor, Service de Néphrologie Transplantation
Créteil, France - (and 11 more...)
|
34 |
NCT01466595 |
Completed Has Results |
Rifaximin as a Modulator of Microbial Translocation and Immune Activation |
|
|
Interventional |
Phase 2 |
- AIDS Clinical Trials Group
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in CD8+ T-cell Activation From Baseline to Week 4
- Change in D-dimer From Baseline to Week 4
- Change in IL-6 From Baseline to Week 4
- (and 40 more...)
|
73 |
All |
18 Years to 65 Years (Adult) |
NCT01466595 |
ACTG A5286 1U01AI068636 |
|
September 2011 |
September 2012 |
November 2012 |
November 8, 2011 |
December 4, 2013 |
November 7, 2013 |
- Alabama Therapeutics CRS (5801)
Birmingham, Alabama, United States - UCLA CARE Center CRS (601)
Los Angeles, California, United States - Stanford CRS (501)
Palo Alto, California, United States - (and 29 more...)
|
35 |
NCT01435018 |
Recruiting |
Three Chemo Regimens as an Adjunct to ART for Treatment of Advanced AIDS-KS |
|
- Drug: Coformulated EFV/FTC/TDF
- Drug: Etoposide
- Drug: Bleomycin and Vincristine (BV)
- Drug: Paclitaxel (PTX)
|
Interventional |
Phase 3 |
- AIDS Clinical Trials Group
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Cancer Institute (NCI)
- National Institute of Dental and Craniofacial Research (NIDCR)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Lack of clinical efficacy
- Death by week 48
- KS progression by week 48
- (and 24 more...)
|
706 |
All |
18 Years and older (Adult, Senior) |
NCT01435018 |
ACTG A5263 1U01AI068636 U01CA121947 |
|
August 2013 |
December 2019 |
December 2022 |
September 15, 2011 |
October 19, 2017 |
|
- Instituto de Pesquisa Clinica Evandro Chagas (12101)
Rio de Janeiro, Brazil - Moi University International Clnical Trials Unit
Eldoret, Kenya - KMRI / Walter Reed Project Clinical Research Center
Kericho, Kenya - (and 8 more...)
|
36 |
NCT01436136 |
Completed |
Reducing Cardiovascular Disease (CVD) Risk in HIV on Antiretroviral Therapy Over 12 Months |
- HIV-1 Infection
- Cardiovascular Disease
|
- Other: Control
- Other: Intervention Group
|
Interventional |
Not Applicable |
- Holdsworth House Medical Practice
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52.
|
92 |
All |
50 Years and older (Adult, Senior) |
NCT01436136 |
Reducing CVD risk in HIV |
CVD |
October 2011 |
June 2014 |
June 2014 |
September 19, 2011 |
May 12, 2015 |
|
- Holdsworth House Medical Practice
Sydney, New South Wales, Australia
|
37 |
NCT01432756 |
Completed Has Results |
A South African Pilot Worksite Parenting Program to Prevent HIV Among Adolescents |
|
- Behavioral: Let's Talk Worksite Parenting Program
|
Interventional |
Not Applicable |
- Boston Children’s Hospital
- National Institutes of Health (NIH)
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Prevention
|
- Number of Topics Discussed Between Parent and Child
|
132 |
All |
11 Years and older (Child, Adult, Senior) |
NCT01432756 |
5R34MH090790-02 5R34MH090790 |
|
September 2011 |
April 2012 |
April 2012 |
September 13, 2011 |
September 9, 2015 |
September 9, 2015 |
- Stellenbosch University
Stellenbosch, Cape Town, South Africa
|
38 |
NCT01445314 |
Enrolling by invitation |
Analysis of Data Collected From Individuals Administered Neurobehavioral Assessments |
- HIV
- Brain Tumors
- Neurofibromatosis 1
|
|
Observational |
|
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Other
|
- Functunial
- Relationship
- Association
- (and 4 more...)
|
497 |
All |
up to 100 Years (Child, Adult, Senior) |
NCT01445314 |
070110 07-C-0110 |
|
February 22, 2007 |
|
|
October 3, 2011 |
April 20, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
39 |
NCT01439503 |
Recruiting |
Safer Sex Program for Young African-American Men |
- Gonorrhea
- Chlamydia
- Trichomoniasis
- (and 2 more...)
|
|
Interventional |
Phase 2 |
- Richard Crosby
- National Institute of Mental Health (NIMH)
- University of Kentucky
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- The frequency of unprotected sex rather than frequency of condom use will be used as the primary outcome measure.
|
620 |
Male |
15 Years to 29 Years (Child, Adult) |
NCT01439503 |
11-0204-F3R 1R01MH092226-01A1 |
|
September 2012 |
May 2018 |
May 2019 |
September 23, 2011 |
October 30, 2017 |
|
- Mississippi State Department of Health STD Clinic
Jackson, Mississippi, United States
|
40 |
NCT01446718 |
Active, not recruiting |
A Cohort Study to Assess Sustained Immunogenicity to qHPV Vaccine Among HIV-infected Girls and Boys Age 9-14 Years |
- Human Papillomavirus
- HIV-1 Infection
|
- Biological: Gardasil vaccine
|
Observational |
|
- Kenyatta National Hospital
- University of Washington
- Merck Sharp & Dohme Corp.
- Kenya Medical Research Institute
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- immune response to vaccine specific HPV types
|
179 |
All |
9 Years to 14 Years (Child) |
NCT01446718 |
(MISP)IISP 51802 |
|
December 2014 |
November 2018 |
December 2019 |
October 5, 2011 |
September 7, 2016 |
|
|
41 |
NCT01449565 |
Completed |
Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM) |
- Amphetamine-Related Disorders
|
- Drug: Naltrexone
- Drug: Placebo
|
Interventional |
Phase 2 |
- San Francisco Department of Public Health
- Alkermes, Inc.
- National Institute on Drug Abuse (NIDA)
|
Other / Industry / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- urine meth positivity
- reduction in sexual risk behavior
- percentage of total expected injections administered
- rates of adverse events
|
100 |
Male |
18 Years to 65 Years (Adult) |
NCT01449565 |
R01DA031678 |
TREX |
September 2012 |
December 2015 |
March 2016 |
October 10, 2011 |
April 13, 2016 |
|
- Substance Use Research Unit
San Francisco, California, United States
|
42 |
NCT01484522 |
Completed |
Laboratory Study of Licensed H1N1 Influenza Vaccines in HIV-1 Perinatally Infected Children and Youth |
- HIV-1 Infection
- H1N1
- Influenza
- Flu
|
- Biological: FluMist
- Biological: Fluvirin
- Biological: Fluzone
|
Observational |
|
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The short term immune response following immunization with a licensed Influenza A (H1N1) 2009 Monovalent Vaccine administered as a single dose in perinatally HIV-1 infected children and youth aged >10 to <25 years.
- The short term immune response following second immunization with a licensed Influenza A (H1N1) 2009 Monovalent Vaccine in perinatally HIV-1 infected children > 6 months to < 10 years of age.
- The immune response following first immunization with a licensed Influenza A (H1N1) 2009 monovalent vaccine in children aged > 6 months to < 10 years of age.
- (and 5 more...)
|
149 |
All |
6 Months to 25 Years (Child, Adult) |
NCT01484522 |
IMPAACT P1089 U01AI068632 |
|
October 2009 |
January 2010 |
September 2010 |
December 2, 2011 |
December 2, 2011 |
|
- Univ. of Alabama Birmingham NICHD CRS (5096)
Birmingham, Alabama, United States - USC/Los Angeles County Medical Center NICHD CRS
Los Angeles, California, United States - University of California San Francisco NICHD CRS (5091)
San Francisco, California, United States - (and 14 more...)
|
43 |
NCT01434238 |
Completed |
Evaluation of an Infant Feeding Intervention for HIV-exposed Haitian Infants |
- Lack of; Care, Infant (Child), Malnutrition
|
- Other: Counseling and nutrition supplement
|
Interventional |
Not Applicable |
- Cornell University
- Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
- Weill Medical College of Cornell University
- University of Virginia
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Change in prevalence of growth faltering during the intervention
- Change in prevalence of growth faltering post-intervention
- Change in prevalence of anemia during intervention
- Dietary intake
|
82 |
All |
6 Months to 18 Months (Child) |
NCT01434238 |
IRB 0907000316 |
|
June 2008 |
January 2010 |
May 2010 |
September 14, 2011 |
September 15, 2011 |
|
- GHESKIO Centres
Port-au-Prince, Quest, Haiti
|
44 |
NCT01447615 |
Active, not recruiting |
Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda |
- Poverty
- Orphaned Children
- AIDS Orphans
|
- Behavioral: Bridges
- Behavioral: Bridges PLUS
- Other: Usual Care
|
Interventional |
Not Applicable |
- Columbia University
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Savings and Asset Accumulation
- Educational Achievement
- Mental Health Functioning
- Sexual Risk-Taking Behavior
|
1440 |
All |
11 Years to 17 Years (Child) |
NCT01447615 |
AAA11950 1R01HD070727-01 |
|
February 2012 |
July 31, 2016 |
July 2018 |
October 6, 2011 |
July 21, 2017 |
|
- International Center for Child Health and Asset Development
Masaka, Rakai and Masaka Districts, Uganda
|
45 |
NCT01445106 |
Completed |
A Phase I Trial of Nelfinavir (Viracept ) in Adults With Solid Tumors |
|
- Drug: Nelfinavir
- Drug: Nelfinavir Mesylate
|
Interventional |
Phase 1 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Non-Randomized
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the safety and toxicity of nelfinavir in human subjects with solid tumors and to determine the maximum tolerated dose in this group of patients.
- To determine the PK of nelfinavir admin, correlate cytochrome P450 3A4 activity with nelfinavir levels and establish prelim evidence of clinical efficacy of this regimen in solid tumor malignancy patients.
|
28 |
All |
18 Years and older (Adult, Senior) |
NCT01445106 |
070047 07-C-0047 |
|
December 11, 2006 |
May 9, 2011 |
May 9, 2011 |
October 3, 2011 |
April 20, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
46 |
NCT01441063 |
Recruiting |
Tocilizumab for KSHV-Associated Multicentric Castleman Disease |
- Castleman Disease
- Castleman's Disease
- Giant Lymph Node Hyperplasia
|
- Drug: Zidovudine
- Drug: Tocilizumab
- Drug: Valganciclovir (VGC)
|
Interventional |
Phase 2 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determine the efficacy of tocilizumab in the treatment of KSHV-MCD.
- Estimate best clinical, biochemical, radiographic and overall response.
- Evaluate progression-free and overall survival with tocilizumab and tocilizumab/AZT/VGC.
- (and 3 more...)
|
17 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT01441063 |
110233 11-C-0233 |
|
August 9, 2011 |
July 1, 2020 |
July 1, 2020 |
September 27, 2011 |
December 28, 2017 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|