| 1 |
NCT01275443 |
Completed |
Study in Healthy Volunteers of the Safety and Metabolism of Different Doses of the Anti-HIV Drug TMC278LA. |
|
- Drug: 300mg TMC278LA
- Drug: 150mg TMC278LA
- Drug: 1200mg TMC278LA
- Drug: 600mg TMC278LA
|
Interventional |
Phase 1 |
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Plasma pharmacokinetics
- TMC278LA concentrations in the genital tract and rectal compartments.
- Safety and tolerability of TMC278LA
- HIV replication in vitro
|
66 |
All |
18 Years to 50 Years (Adult) |
NCT01275443 |
SSAT 040 |
|
January 2011 |
June 2012 |
June 2012 |
January 12, 2011 |
June 26, 2017 |
|
- St Stephen's AIDS Trust
London, United Kingdom
|
| 2 |
NCT01264445 |
Completed |
Safety and Immunogenicity Study of 2 Investigational Preventive HIV Vaccines |
|
- Biological: Adjuvanted GSK investigational HIV vaccine formulation 1
- Biological: Adjuvanted GSK investigational HIV vaccine formulation 2
- Biological: Ad35 investigational HIV vaccine
- Biological: Placebo (saline)
|
Interventional |
Phase 1 |
- International AIDS Vaccine Initiative
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Safety of an adjuvanted HIV protein vaccine in prime-boost combinations with AD35-GRIN or coadministered with AD35-GRIN
- Immunogenicity of an adjuvanted HIV protein vaccine given in different prime-boost regimens with Ad35-GRIN or coadminisitered with Ad35-GRIN
|
147 |
All |
18 Years to 40 Years (Adult) |
NCT01264445 |
IAVI B002 |
|
February 2011 |
November 2012 |
November 2012 |
December 21, 2010 |
February 11, 2013 |
|
- Kenya AIDS Vaccine Initiative
Nairobi, Kenya - Uganda Virus Research Institute-IAVI
Entebbe, Uganda - Medical Research Council
Masaka, Uganda - Zambia-Emory HIV Research Project
Lusaka, Zambia
|
| 3 |
NCT01271894 |
Completed |
The Intensive Pharmacokinetics Sub-study of Encore1 (ENCORE1-PK) |
|
|
Interventional |
Phase 3 |
- Kirby Institute
- Chelsea and Westminster NHS Foundation Trust
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Screening
|
- To compare the pharmacokinetic parameters of EFV determined from blood collected over a 24-hour dosing interval in blinded samples from participants taking either 600 mg or 400 mg once daily in combination with Truvada.
- To compare the safety and tolerability of EFV 400 mg versus 600 mg given once daily.
- To investigate the correlation between EFV concentration measurements from dried blood spots and concentration measured in matched plasma samples.
|
40 |
All |
16 Years and older (Child, Adult, Senior) |
NCT01271894 |
NCHECR-ENCORE1-PK |
|
September 2011 |
May 2013 |
May 2013 |
January 7, 2011 |
May 13, 2013 |
|
- Hospital J.M. Ramos Mejia
Buenos Aires, Argentina - Desmond Tutu HIV Foundation
Cape Town, South Africa - Thai Red Cross-AIDS Research Centre, HIV-NAT Research Collaboration
Bangkok, Thailand - Chelsea and Westminister Hospital
London, United Kingdom
|
| 4 |
NCT01277458 |
Unknown † |
Ethnicity Data in HIV Positive Men Who Have Sex With Men |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Proportion of misclassification of ethnicity for non-White MSM with HIV living in London
- • Prevalence of individual non-White self-identified ethnicity groups in MSM with HIV in London
- Description of current clinic practice for ethnicity data recording
|
400 |
Male |
18 Years and older (Adult, Senior) |
NCT01277458 |
EthMSM01 |
|
June 2011 |
July 2011 |
July 2011 |
January 17, 2011 |
January 17, 2011 |
|
- Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
|
| 5 |
NCT01266616 |
Completed |
Safety of and Immune Response to an Investigational HIV-1 Vaccine With or Without Interleukin-12 (IL-12) in HIV-1 Infected Adults |
|
- Biological: Profectus HIV MAG pDNA vaccine
- Biological: IL-12
- Other: Placebo
|
Interventional |
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Occurrence of at least one greater than Grade 3 adverse event (AE) including signs/symptoms, lab toxicities, and/or clinical events that is possibly, probably, or definitely related to study treatment, as judged by the core team
- Change in the number of interferon (IFN)-gamma generating (in response to gag) CD4 T cells/million peripheral blood mononuclear cells (PBMCs) as measured by intracellular cytokine staining (ICS)
- Answering "no" to the question, "In your opinion, would this study's vaccination procedure be acceptable as part of a treatment for HIV, if it proved to be effective?"
- (and 4 more...)
|
62 |
All |
18 Years to 55 Years (Adult) |
NCT01266616 |
A5281
10846 |
|
March 2011 |
October 2012 |
April 2013 |
December 24, 2010 |
November 25, 2015 |
|
- UCLA CARE Center CRS
Los Angeles, California, United States - Stanford AIDS Clinical Trials Unit CRS
Palo Alto, California, United States - Ucsf Hiv/Aids Crs
San Francisco, California, United States - (and 10 more...)
|
| 6 |
NCT01300988 |
Completed |
Effects of Treatment With Aprepitant (Emend®) in HIV Infected Individuals. 375 mg Dose |
|
- Drug: Aprepitant
- Drug: Aprepitant placebo
|
Interventional |
Phase 1 |
- University of Pennsylvania
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Virologic: Change in log10 HIV-1 RNA from baseline to Day 14
- Safety: Incidence of Grade 2, 3, and 4 adverse events
- Pharmacokinetic
- (and 2 more...)
|
18 |
All |
18 Years and older (Adult, Senior) |
NCT01300988 |
811938
U01MH090325 |
|
December 2010 |
August 2013 |
August 2013 |
February 23, 2011 |
June 3, 2016 |
|
- Clinical Trials Unit. University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
| 7 |
NCT01288755 |
Completed |
TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir |
|
- Drug: TMC278
- Drug: Raltegravir
|
Interventional |
Phase 1 |
- Tibotec Pharmaceuticals, Ireland
- Raltegravir is provided by Merck.
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in exposure to TMC278 following co-administration with raltegravir and vice versa
- Number of participants with adverse events as a measure of safety and tolerability - TMC278 and raltegravir.
|
24 |
All |
18 Years to 55 Years (Adult) |
NCT01288755 |
CR017773
TMC278-TiDP6-C153 |
|
February 2011 |
|
May 2011 |
February 2, 2011 |
June 27, 2011 |
|
|
| 8 |
NCT01262846 |
Completed
Has Results |
Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals |
|
|
Interventional |
Phase 4 |
- University of Pennsylvania
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
|
195 |
All |
18 Years and older (Adult, Senior) |
NCT01262846 |
UPenn FLU 02 |
|
November 2010 |
April 2011 |
April 2011 |
December 17, 2010 |
April 13, 2017 |
April 13, 2017 |
- Clinical Trials Unit. University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
| 9 |
NCT01451333 |
Completed |
The Efavirenz (EFV) Central Nervous System Exposure Sub-study of Encore1 |
|
|
Interventional |
Phase 3 |
- Kirby Institute
- Imperial College London
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- comparison of mean CSF concentration of EFV from both doses after week 24.
- CSF EFV exposure and plasma exposure (CSF:plasma ratio) using statistical analysis
- The relationship between CSF EFV exposure and neuropsychiatric side effects using questionnaires and medical assessments
- (and 6 more...)
|
32 |
All |
16 Years and older (Child, Adult, Senior) |
NCT01451333 |
NCHECR-ENCORE1-CNS |
ENCORE1-CNS |
September 2011 |
October 2012 |
February 2013 |
October 13, 2011 |
May 13, 2013 |
|
- Medical Group Practice
Berlin, Germany - HIVNAT Research Collaboration
Patumwan, Bangkok, Thailand - Khon Kaen University
Khon Kaen, Thailand - (and 2 more...)
|
| 10 |
NCT01289171 |
Completed |
Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients |
- Flat Warts (Diagnosis)
- HIV Infections
|
|
Interventional |
Not Applicable |
- University of Pennsylvania
- NeoStrata Company, Inc.
- Penn Center for AIDS Research (CFAR)
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Treatment efficacy of 15% glycolic acid lotion for flat warts
- Safety and tolerability of 15% glycolic acid lotion for flat warts
- HPV typing in EV-like flat warts
|
38 |
All |
7 Years and older (Child, Adult, Senior) |
NCT01289171 |
P30AI045008 |
|
January 2009 |
June 2009 |
October 2010 |
February 3, 2011 |
February 3, 2011 |
|
- Princess Marina Hospital
Gaborone, Botswana
|
| 11 |
NCT01276990 |
Withdrawn |
Safety and Pharmacokinetics of Multiple Rising Oral Doses of BI 224436 in Healthy Male Volunteers. |
|
- Drug: BI 224436
- Drug: Placebo
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Changes in blood pressure
- Changes in pulse rate
- Changes in 12-lead ECG
- (and 8 more...)
|
0 |
Male |
18 Years to 50 Years (Adult) |
NCT01276990 |
1277.2 |
|
January 2011 |
September 2012 |
|
January 14, 2011 |
February 9, 2012 |
|
|
| 12 |
NCT01270100 |
Completed |
Recovery Management Intervention in China |
|
- Behavioral: Recovery management
|
Interventional |
Not Applicable |
- University of California, Los Angeles
- National Institute on Drug Abuse (NIDA)
|
Other / NIH |
|
|
|
All |
18 Years and older (Adult, Senior) |
NCT01270100 |
DA025385
1R21DA025385-01 |
|
|
|
|
January 5, 2011 |
January 5, 2011 |
|
- Shanghai Mental Health Center
Shanghai, China
|
| 13 |
NCT01283100 |
Withdrawn |
A Drug Interaction Study Evaluating Plasma GSK2248761 and GSK1349572 Pharmacokinetics in Healthy Adult Subjects. |
- Infection, Human Immunodeficiency Virus I
|
- Drug: GSK1349572
- Drug: GSK2248761
|
Interventional |
Phase 1 |
- ViiV Healthcare
- GlaxoSmithKline
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
|
- Plasma GSK1349572 steady state area under the curve (AUC) 0-tau following 50 mg q24h administration with and without GSK2248761 200 mg q24h
- Plasma GSK1349572 steady state maximum observed concentration (Cmax) following 50 mg q24h administration with and without GSK2248761 200 mg q24h
- Plasma GSK1349572 steady state Pre-dose trough concentration at the end of the dosing interval (Ctau) following 50 mg q24h administration with and without GSK2248761 200 mg q24h
- (and 21 more...)
|
0 |
All |
18 Years to 55 Years (Adult) |
NCT01283100 |
114122 |
|
March 2011 |
March 2011 |
June 2011 |
January 25, 2011 |
December 24, 2014 |
|
- GSK Investigational Site
Buffalo, New York, United States
|
| 14 |
NCT01291485 |
Completed |
Electronic Intervention for HIV Medication Adherence |
|
- Behavioral: Life Steps for Medication Adherence
|
Interventional |
Not Applicable |
- Oklahoma State University Center for Health Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Supportive Care
|
- HIV medication adherence
- HIV Treatment Adherence Self-Efficacy
- Quality of Life
- (and 2 more...)
|
97 |
All |
18 Years and older (Adult, Senior) |
NCT01291485 |
2010022 |
|
January 2011 |
September 2011 |
November 2011 |
February 8, 2011 |
October 10, 2012 |
|
- Internal Medicine Specialty Services
Tulsa, Oklahoma, United States
|
| 15 |
NCT01263938 |
Completed |
Modulation of Monocyte Activation by Atorvastatin in HIV Infection |
|
|
Interventional |
Phase 4 |
- University of Pennsylvania
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Effect of statins on peripheral blood monocytes
- Effect of statins on T cell markers
|
5 |
All |
18 Years and older (Adult, Senior) |
NCT01263938 |
IRB Protocol #: 812196
P30AI045008 |
|
September 2011 |
October 2017 |
October 2017 |
December 21, 2010 |
December 12, 2017 |
|
- University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States
|
| 16 |
NCT01327755 |
Completed |
Rwanda Selenium Supplementation Clinical Trial |
|
- Dietary Supplement: Selenium
- Other: Placebo
|
Interventional |
Phase 3 |
- The Canadian College of Naturopathic Medicine
- Global Benefit Canada
- University of Ottawa
- (and 3 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- CD4 count
- viral load
- Occurrence of opportunistic infections
- Incidence of antiretroviral therapy (ART)initiation
|
300 |
All |
21 Years and older (Adult, Senior) |
NCT01327755 |
RCT-32122010 |
RSST |
February 2011 |
August 2013 |
August 2013 |
April 4, 2011 |
October 29, 2013 |
|
- Kibagabaga Hospital
Kigali, Rwanda - Kinyinya Health Center
Kigali, Rwanda
|
| 17 |
NCT01279005 |
Unknown † |
Risk Taking Behaviour in MSM and the Denial of Sexually Transmitted Diseases and HIV |
- MSM
- HIV Infections
- Risky Behaviors
|
|
Observational |
|
- Rambam Health Care Campus
- NGO Via Libre
|
Other |
- Time Perspective: Prospective
|
|
50 |
Male |
20 Years to 50 Years (Adult) |
NCT01279005 |
0425-10CTIL |
MSM HIV |
February 2011 |
April 2011 |
July 2011 |
January 19, 2011 |
January 19, 2011 |
|
|
| 18 |
NCT01269515 |
Completed |
Immunomodulating Therapy and Improved Vaccination Responses by Cox-2 Inhibitor in HIV-infected Patients |
|
|
Interventional |
Phase 2 |
- Dag Kvale
- The Research Council of Norway
- Oslo University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Changes in progression markers and vaccine responses within and between ART groups
- Serious adverse events
- Changes in HIV Gag CD8+ T cell responses within and between ART groups
- Changes in plasma markers of inflammation, coagulation and tryptophan metabolism within and between ART groups
|
60 |
All |
18 Years to 65 Years (Adult) |
NCT01269515 |
OUSCOX2 |
OUSCOX2 |
October 2010 |
November 2014 |
November 2014 |
January 4, 2011 |
May 31, 2017 |
|
- Department of Infectious Diseases, Oslo University Hospital
Oslo, Norway - The Biotechnology Centre, University of Oslo
Oslo, Norway
|
| 19 |
NCT01263717 |
Completed
Has Results |
Effects of Growth Hormone Releasing Hormone in HIV |
|
- Drug: tesamorelin
- Drug: placebo
|
Interventional |
Not Applicable |
- Massachusetts General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Liver Fat
- Visceral Adipose Tissue
- Intramyocellular Lipid
- (and 9 more...)
|
54 |
All |
18 Years to 65 Years (Adult) |
NCT01263717 |
2007p-000638 |
|
December 2010 |
February 2014 |
February 2014 |
December 21, 2010 |
October 30, 2017 |
October 13, 2014 |
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 20 |
NCT01275625 |
Completed
Has Results |
Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia |
|
|
Interventional |
Phase 4 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.
- Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.
- Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.
- (and 8 more...)
|
98 |
All |
18 Years and older (Adult, Senior) |
NCT01275625 |
A4001101 |
|
June 2011 |
October 2012 |
July 2013 |
January 12, 2011 |
March 3, 2014 |
March 3, 2014 |
- Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
Krasnoyarsk, Russian Federation - Federal scientific and methodological center on AIDS prophylaxis and control
Moscow, Russian Federation - Moscow regional center on AIDS and infectious diseases prophylaxis and control
Moscow, Russian Federation - (and 5 more...)
|
| 21 |
NCT01276600 |
Completed |
Dose-Proportionality and Intra-Individual Variability of Intracellular TFV-DP and FTC-TP in Healthy Volunteers |
|
- Drug: Emtricitabine/tenofovir
|
Interventional |
Phase 1 |
- HIV Prevention Trials Network
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Assess dose-proportionality
- Comparison of intra-individual variability--days 28 and 35
- Determine relationship between pre-dose and decaying concentrations
- (and 2 more...)
|
32 |
All |
18 Years to 44 Years (Adult) |
NCT01276600 |
HPTN 066 |
HPTN066 |
January 2011 |
October 2011 |
October 2011 |
January 13, 2011 |
November 30, 2011 |
|
- Johns Hopkins University
Baltimore, Maryland, United States - University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
|
| 22 |
NCT01272258 |
Withdrawn |
A Trial of Observed Long-acting, Anti-HIV Treatment With a Monoclonal CCR5 Antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-infected Injection Drug Users With Viral Rebound and Documented Poor Adherence |
|
- Drug: PRO 140
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Specific measure that will be used to determine the effect of the interventions: Percentage of subjects without virologic failure at week 24.
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT01272258 |
PRO 140 2102 |
|
December 2013 |
January 2017 |
February 2017 |
January 7, 2011 |
February 2, 2017 |
|
- Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
|
| 23 |
NCT01270802 |
Completed
Has Results |
Effects of Switching Efavirenz to Raltegravir on Vascular Function and Bone Markers in HIV-infected Patients |
|
- Drug: Tenofovir/emtricitabine
- Drug: Tenofovir/emtricitabine/efavirenz
- Drug: Raltegravir
|
Interventional |
Phase 4 |
- Indiana University
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Flow-mediated Dilation (FMD) of the Brachial Artery
- Change in Serum Levels of Vitamin D
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT01270802 |
Merck 38258 |
|
April 2011 |
October 2012 |
April 2013 |
January 5, 2011 |
December 18, 2013 |
October 24, 2013 |
- Indiana University School of Medicine
Indianapolis, Indiana, United States
|
| 24 |
NCT01268839 |
Completed |
A Phase I, Open-label Trial to Explore the Pharmacokinetics, Safety and Tolerability of TMC278 (Rilpivirine) 25 mg Once Daily Following a 2-week Period Receiving Efavirenz, in Healthy Male and Female Volunteers |
|
- Drug: TMC278
- Drug: Efavirenz
|
Interventional |
Phase 1 |
- Tibotec, Inc
- Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- Pharmacokinetics of TMC278 25 mg once daily (q.d.) following a preceding 2-week treatment period with EFV 600 mg q.d., in healthy volunteers
- To evaluate the EFV inducing effect on TMC278 metabolism after EFV intake cessation, through comparison of TMC278 plasma concentrations with and without preceding EFV intake
- To evaluate EFV plasma concentrations over time after cessation of EFV intake
- To assess the safety (including vital signs and electrocardiogram [ECG] measurements, laboratory assessments, and incidence of overall AEs and tolerability) of TMC278 at a dose of 25 mg q.d administered alone and after switching from EFV over a period of
|
20 |
All |
18 Years to 65 Years (Adult) |
NCT01268839 |
CR016984
TMC278HIV1001 |
|
January 2010 |
May 2010 |
May 2010 |
December 31, 2010 |
September 4, 2013 |
|
|
| 25 |
NCT01263015 |
Completed
Has Results |
A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial) |
- Infection, Human Immunodeficiency Virus I
|
- Drug: Dolutegravir
- Drug: Atripla
- Drug: Abacavir/Lamivudine
- (and 3 more...)
|
Interventional |
Phase 3 |
- ViiV Healthcare
- Shionogi
- GlaxoSmithKline
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48
- Time to Viral Suppression (<50 c/mL)
- Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144
- (and 8 more...)
|
844 |
All |
18 Years and older (Adult, Senior) |
NCT01263015 |
114467 |
|
February 1, 2011 |
May 14, 2012 |
December 3, 2015 |
December 20, 2010 |
April 4, 2018 |
July 2, 2014 |
- GSK Investigational Site
Hobson City, Alabama, United States - GSK Investigational Site
Little Rock, Arkansas, United States - GSK Investigational Site
Bakersfield, California, United States - (and 142 more...)
|
| 26 |
NCT01273103 |
Withdrawn |
A Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK2248761 Administered as an Oral Suspension to Healthy Adult Subjects |
- Infection, Human Immunodeficiency Virus
|
- Drug: 200mg [14C]- GSK2248761
|
Interventional |
Phase 1 |
- ViiV Healthcare
- GlaxoSmithKline
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- Percent recovery of total radiocarbon in urine and feces
- Area under the concentration-time curve from time zero to last time of quantifiable concentration within a subject (AUC (0-t)) of total drug-related material (radiocarbon) in blood and plasma
- Area under the concentration-time curve from time zero extrapolated to infinite time (AUC (0-infinity)) of total drug-related material (radiocarbon) in blood and plasma
- (and 22 more...)
|
0 |
Male |
30 Years to 55 Years (Adult) |
NCT01273103 |
113393 |
|
January 2011 |
February 2011 |
February 2011 |
January 10, 2011 |
May 19, 2014 |
|
- GSK Investigational Site
Madison, Wisconsin, United States
|
| 27 |
NCT01273142 |
Unknown † |
Compare to the Safety of Efavirenz and Nevirapine in Treating HIV Positive Patients With Mild Baseline Liver Function Test Impairment, and/or Hepatitis B or Hepatitis C Co-infection |
- HIV Infections
- Liver Toxicity
- Hepatitis Co-infection
|
|
Observational |
|
- Henan Provincial Hospital
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
100 |
All |
18 Years to 60 Years (Adult) |
NCT01273142 |
zzly-37183 |
|
January 2011 |
October 2012 |
December 2012 |
January 10, 2011 |
January 10, 2011 |
|
|
| 28 |
NCT01280136 |
Completed |
Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact |
- HIV
- Sexually Transmitted Diseases
|
- Behavioral: It's Your Game Tech
|
Interventional |
Not Applicable |
- The University of Texas Health Science Center, Houston
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- sexual initiation
- sexual activity in past 3 months
- unprotected sexual intercourse
- number of sexual partners
|
1700 |
All |
12 Years to 16 Years (Child) |
NCT01280136 |
R01MH085594 |
|
December 2009 |
June 2013 |
June 2013 |
January 20, 2011 |
June 13, 2014 |
|
- University of Texas Houston School of Public Health
Houston, Texas, United States
|
| 29 |
NCT01281813 |
Active, not recruiting |
TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir(Rtv) in HIV1 Infected Adults, Adolescents and Children Aged 3 Years or Above and Coming From Previous Company Sponsored Studies With DRV |
|
- Drug: Darunavir
- Drug: Ritonavir
|
Interventional |
Phase 3 |
- Janssen Sciences Ireland UC
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- All serious adverse events, adverse events leading to discontinuation, and adverse events at least possibly related to the DRV treatment, as measures of the safety and tolerability of DRV/rtv in combination with other ARVs
|
133 |
All |
3 Years and older (Child, Adult, Senior) |
NCT01281813 |
CR017230
TMC114IFD3001
2017-000285-30 |
|
August 8, 2011 |
December 31, 2018 |
December 31, 2021 |
January 24, 2011 |
February 28, 2018 |
|
- Rio De Janeiro, Brazil
- San Jose, Costa Rica
- Guatemala, Guatemala
- (and 14 more...)
|
| 30 |
NCT01266902 |
Active, not recruiting |
A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1 |
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The number of participants affected by an adverse event
- Any Division of AIDS (DAIDS) grade 3/4 rash
- HIV RNA levels
- CD4+ cell count
|
483 |
All |
18 Years and older (Adult, Senior) |
NCT01266902 |
CR017434
TMC278-TiDP6-C222
2010-021209-18 |
|
February 25, 2011 |
December 31, 2018 |
December 31, 2018 |
December 24, 2010 |
February 28, 2018 |
|
- Beverly Hills, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- (and 101 more...)
|
| 31 |
NCT01274780 |
Completed |
Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV-1 Infected Patients |
|
- Drug: Darunavir / Ritonavir + Tenofovir / Emtricitabine
- Drug: Atazanavir / Ritonavir + Tenofovir / Emtricitabine
|
Interventional |
Phase 4 |
- Juan A. Arnaiz
- Hospital Clinic of Barcelona
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Changes in total cholesterol
- Blood levels of: triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and ratio of total cholesterol/HDL cholesterol
- Cardiovascular risk according to the Framingham scale.
- (and 6 more...)
|
180 |
All |
18 Years and older (Adult, Senior) |
NCT01274780 |
ATADAR |
|
May 2011 |
May 2013 |
January 2014 |
January 12, 2011 |
December 16, 2014 |
|
- Hospital Clinic
Barcelona, Spain
|
| 32 |
NCT01270061 |
Withdrawn |
Project Wellness: Increasing HIV Testing Among West African Immigrants |
|
- Behavioral: HIV testing
- Behavioral: General Health Screen
|
Interventional |
Not Applicable |
- North Bronx Healthcare Network
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Care Provider)
- Primary Purpose: Diagnostic
|
- HIV testing rate
- Health Knowledge
- Risk perception
- Linkage to care
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT01270061 |
2010-587 |
|
April 2012 |
March 2015 |
June 2015 |
January 5, 2011 |
May 8, 2015 |
|
- Community Bronx
Bronx, New York, United States
|
| 33 |
NCT01319526 |
Terminated |
Biomarkers in Blood Samples From Patients With HIV Infection and Stage III or Stage IV Hodgkin Lymphoma Undergoing Chemotherapy |
- Lymphoma
- Nonneoplastic Condition
|
- Genetic: DNA analysis
- Genetic: RNA analysis
- Other: laboratory biomarker analysis
|
Observational |
|
- AIDS Malignancy Consortium
- National Cancer Institute (NCI)
- The EMMES Corporation
|
Other / NIH / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in viral load from baseline to each subsequent time point
|
1 |
All |
18 Years and older (Adult, Senior) |
NCT01319526 |
AMC-079
CDR0000690149 |
|
June 2011 |
January 2013 |
January 2013 |
March 21, 2011 |
October 5, 2015 |
|
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
|
| 34 |
NCT01352715 |
Completed
Has Results |
Study of Options for Second-Line Effective Combination Therapy (SELECT) |
|
- Drug: Lopinavir/ritonavir
- Drug: Raltegravir
- Drug: Emtricitabine/tenofovir disoproxil fumarate
- (and 6 more...)
|
Interventional |
Phase 3 |
- 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
|
- Cumulative Probability of Virologic Failure by Week 48
- Change in CD4+ Cell Count From Baseline to Week 48
- Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure
- (and 6 more...)
|
515 |
All |
18 Years and older (Adult, Senior) |
NCT01352715 |
ACTG A5273
1U01AI068636
5UM1AI068634 |
SELECT |
January 2012 |
October 2014 |
October 2014 |
May 12, 2011 |
January 6, 2016 |
January 6, 2016 |
- Instituto de Pesquisa Clinica Evandro Chagas (12101)
Rio de Janeiro, Brazil - BJ Medical College CRS (31441)
Pune, Maharashtra, India - NARI Pune CRS
Pune, Maharashtra, India - (and 13 more...)
|
| 35 |
NCT01262976 |
Completed |
Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Human Immunodeficiency Virus (HIV)-Positive Adults |
|
- Biological: GSK's investigational vaccine 692342
- Biological: Physiological saline
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Number of subjects with grade 3 solicited local symptoms
- Number of subjects with grade 3 solicited general symptoms
- Number of subjects with grade 3 unsolicited adverse events (AEs)
- (and 13 more...)
|
240 |
All |
18 Years to 59 Years (Adult) |
NCT01262976 |
113935 |
|
January 2011 |
July 2012 |
June 2015 |
December 20, 2010 |
December 6, 2016 |
|
- GSK Investigational Site
Tharamani Chennai, India
|
| 36 |
NCT01276236 |
Unknown † |
Effects of Maraviroc (MVC) on HIV-related Kaposi's Sarcoma (KS) |
|
|
Interventional |
Not Applicable |
- University of California, San Francisco
- Pfizer
- ViiV Healthcare
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Kaposi's Sarcoma Lesion Burden between Baseline and Week 1
- Change in Kaposi's Sarcoma Lesion Burden between Baseline and Week 2
- Change in Kaposi's Sarcoma Lesion Burden between Baseline and Week 4
- (and 37 more...)
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT01276236 |
10-02850
2860798 |
|
February 2011 |
January 2015 |
April 2015 |
January 13, 2011 |
July 24, 2014 |
|
- San Francisco General Hospital, Clinical Trials Unit
San Francisco, California, United States
|
| 37 |
NCT01277640 |
Completed |
Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures |
|
- Drug: dapivirine
- Drug: matched placebo
- Drug: universal placebo
|
Interventional |
Phase 1 |
- International Partnership for Microbicides, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- To determine the genitourinary safety of dapivirine gel (0.05%), the endpoint was the proportion of men subjected to dapivirine gel or placebo gel experiencing specific, protocol-defined safety events during the study (see description).
- To assess the pharmacokinetics in plasma following 7 days of once daily penile application of dapivirine gel (0.05%)
- To assess the systemic safety following 7 days of once daily penile application of dapivirine gel (0.05%)
- To assess the acceptability following 7 days of once daily penile application of dapivirine gel (0.05%)
|
48 |
Male |
18 Years and older (Adult, Senior) |
NCT01277640 |
MTN-012/IPM 010 |
|
March 2011 |
July 2011 |
July 2011 |
January 17, 2011 |
September 8, 2017 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
|
| 38 |
NCT01277627 |
Unknown † |
Influence of Nevirapine on HCV Viral Load |
- HCV Infection.
- HCV Viral Load.
|
- Drug: Nevirapine
- Drug: efavirenz, protease inhibitors
|
Interventional |
Not Applicable |
- Valme University Hospital
- Boehringer Ingelheim
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- Changes in HCV viral load
|
60 |
All |
18 Years to 65 Years (Adult) |
NCT01277627 |
JAP-NEV-2010-01 |
HELICON |
January 2011 |
July 2012 |
|
January 17, 2011 |
January 17, 2011 |
|
- Valme University Hospital
Seville, Spain
|
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