1 |
NCT01024556 |
Completed |
Observational Study on Anti-Tat Immune Response in HIV-1-infected HAART-treated Adult Subjects |
|
|
Observational |
|
- Barbara Ensoli, MD
- Istituto Superiore di Sanità
|
Other |
- Time Perspective: Prospective
|
- Assessment of anti-Tat antibodies in sera of subjects, and of the proliferative response (CFSE) and the production of γIFN, IL-4 and IL-2 (Elispot) by peripheral blood mononuclear cells (PBMC) in response to Tat.
- The decline of CD4+ T cell counts, the increase of HIV plasma viral load or the occurrence of AIDS-defining events were assessed to determine progression to disease.
|
142 |
All |
18 Years and older (Adult, Senior) |
NCT01024556 |
ISS OBS T-002 |
ISS OBS T-002 |
March 2008 |
|
February 2012 |
December 2, 2009 |
March 4, 2016 |
|
- S.M. Goretti Hospital
Latina, Rome, Italy - General Hospital of Bari
Bari, Italy - Spedali Civili di Brescia
Brescia, Italy - (and 7 more...)
|
2 |
NCT01024595 |
Completed |
Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT |
|
|
Observational |
|
- Istituto Superiore di Sanità
|
Other |
- Time Perspective: Prospective
|
- To evaluate the persistence of specific immune responses, volunteers will be monitored for anti-Tat specific antibodies, anti-Tat proliferative response and in vitro γIFN and IL-4 production in response to Tat (Elispot).
- To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials.
|
24 |
All |
18 Years to 50 Years (Adult) |
NCT01024595 |
ISS OBS T-001 |
ISS OBS T-001 |
September 2007 |
|
December 2010 |
December 3, 2009 |
March 1, 2011 |
|
- San Raffaele Hospital
Milan, Italy - I.R.C.C.S. Spallanzani Hospital
Rome, Italy - S. Gallicano Hospital
Rome, Italy
|
3 |
NCT01025427 |
Unknown † |
HIV Persistence and Viral Reservoirs |
|
- Drug: Raltegravir, tenofovir/emtricitabine
|
Interventional |
Phase 4 |
- University of California, San Francisco
- California HIV/AIDS Research Program
- Gilead Sciences
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in proportion of controllers with detectable plasma HIV RNA (using an ultrasensitive <1 copy/mL assay) from baseline to Week 4
|
20 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01025427 |
H52889-35080 |
|
December 2009 |
June 2011 |
June 2013 |
December 3, 2009 |
April 3, 2012 |
|
- San Francisco General Hospital
San Francisco, California, United States
|
4 |
NCT01029548 |
Completed |
Observational Study on Anti-Tat Immune Response in HIV-1-infected Asymptomatic Adult Subjects |
|
|
Observational |
|
- Barbara Ensoli, MD
- Istituto Superiore di Sanità
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Specific humoral and cellular immune responses to Tat will be monitored by assessing anti-Tat specific antibodies in sera, proliferative response (CFSE) and production of γIFN, IL-4 and IL-2 (Elispot) by peripheral blood mononuclear cells.
- The decline of CD4+ T cells count, the increase of the HIV plasma viral load or the occurrence of AIDS-defining events will be assessed to determine the progression to disease
|
73 |
All |
18 Years and older (Adult, Senior) |
NCT01029548 |
ISS OBS T-003 |
ISS OBS T-003 |
April 2008 |
|
May 2012 |
December 10, 2009 |
March 4, 2016 |
|
- S.M. Goretti Hospital
Latina, Rome, Italy - General Hospital of Bari
Bari, Italy - Spedali Civili di Brescia
Brescia, Italy - (and 7 more...)
|
5 |
NCT01031849 |
Terminated |
Analysis of Changes in Adipose Tissue of Patients With Lipoatrophy HIV Infection Treated With Nucleoside Thymidine, After Switching to Monotherapy With Lopinavir / Ritonavir |
|
|
Interventional |
Phase 4 |
- Ines Perez
- Hospital San Carlos, Madrid
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- Change in those representative gene expression of adipose tissue toxicity (variable established from those gene involved in adipogenesis, inflammation and metabolism. This gene expression will counted)
- Changes in physical fat deposits
- Changes in leptine and adiponectine plasma levels
- Patients percentage with virologic response (ARN-VIH< 50 copies/mL)
|
7 |
All |
18 Years and older (Adult, Senior) |
NCT01031849 |
HCSKAL-2009-01 2009-016090-14 |
BIOKAL |
February 2010 |
October 2012 |
November 2012 |
December 15, 2009 |
April 8, 2013 |
|
- Fundación Jiménez Díaz
Madrid, Spain - Hospital Clínico San Carlos
Madrid, Spain
|
6 |
NCT01015989 |
Unknown † |
Computerized Counseling to Promote Positive Prevention and HIV Health in Kenya |
|
- Other: CARE+ Kenya brief computer risk assessment session
- Other: CARE+ Kenya computer counseling session
|
Interventional |
Phase 4 |
- New York University
- Indiana University
- Moi University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- ART adherence will be measured by HIV-1 viral load, electronic monitoring, pharmacy refill, self-report, and clinic attendance
- HIV transmission risk will be measured by self-reported unprotected sex with HIV negative/unknown partner, and trends in Chlamydia trachomatis, Neisseria gonorrhoeae, and T. vaginalis.
- We will conduct economic evaluation to compare CARE+ Kenya vs. standard of care.
- (and 2 more...)
|
250 |
All |
18 Years and older (Adult, Senior) |
NCT01015989 |
1R01MH085577 |
CARE+ Kenya |
January 2011 |
February 2012 |
June 2013 |
November 18, 2009 |
February 22, 2012 |
|
- AMPATH at Burnt Forest Health Centre
Burnt Forest, Rift Valley, Kenya - AMPATH Module 1
Eldoret, Kenya
|
7 |
NCT01013935 |
Completed |
A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish] |
|
- Other: CARE+ Spanish computer counseling session
- Other: CARE+ Spanish brief computer risk assessment session
|
Interventional |
Phase 4 |
- New York University
- St. Luke's-Roosevelt Hospital Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- ART adherence
- HIV-1 viral load
- Sexual risks
- (and 3 more...)
|
556 |
All |
18 Years and older (Adult, Senior) |
NCT01013935 |
1RC1MH088307 |
CARE+ Spanish |
June 2010 |
July 2013 |
July 2013 |
November 16, 2009 |
November 24, 2014 |
|
- St. Luke's Roosevelt
New York, New York, United States
|
8 |
NCT01031589 |
Completed |
TMC278-TiDP15-C158 - A Study to Examine the Safety, Tolerability and Pharmacokinetics of a Single Dose or Three Successive Doses of Intramuscularly (IM) Injected Long Acting Formulation of TMC278 |
|
- Drug: TMC278 (Rilpivirine) LA; Placebo
|
Interventional |
Phase 1 |
- Tibotec Pharmaceuticals, Ireland
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Prevention
|
- Rate and extent of absorption of TMC278 following single or three successive IM injections
- Results of Injection Site evaluations
- Safety Assessments (monitoring AEs, Lab, Vital Signs, ECG parameters)
|
19 |
All |
18 Years to 58 Years (Adult) |
NCT01031589 |
CR016747 |
|
January 2010 |
July 2011 |
July 2011 |
December 14, 2009 |
November 20, 2012 |
|
|
9 |
NCT01029249 |
Completed |
Examining the Incidence of Oral Human Papillomavirus (HPV) Shedding and Oral Warts After Beginning HAART in HIV-Infected Adults |
|
|
Observational |
|
- AIDS Clinical Trials Group
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Type-specific oral HPV DNA shedding (presence versus absence)
- Persistence of same type HPV DNA shedding from pre-entry/baseline visits to Week 16 and 24 visits
- Clinical diagnosis (presence versus absence) of oral warts
- (and 16 more...)
|
500 |
All |
18 Years and older (Adult, Senior) |
NCT01029249 |
ACTG A5272 1U01AI068636 |
|
January 2010 |
May 2013 |
May 2013 |
December 9, 2009 |
December 6, 2013 |
|
- Alabama Therapeutics CRS (5801)
Birmingham, Alabama, United States - University of Southern California CRS (1201)
Los Angeles, California, United States - UCLA CARE Center CRS (601)
Los Angeles, California, United States - (and 32 more...)
|
10 |
NCT01040039 |
Terminated |
Pilot Study to Assess Gut Mucosal B Cells in Individuals With HCV and HIV |
- HIV Infections
- Hepatitis C Virus
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Numbers of HCV-specific gut mucosal B cells in HCV+HIV+, compared to HCV+HIV- subjects
- Numbers of HCV-specific gut mucosal B cells in HCV-HIV+ and HCV-HIV- subjects
- Distribution of gut mucosal B cell Ig gene segment usage in HCV+HIV+, compared to HCV+HIV- subjects
|
20 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01040039 |
ECH-0675 |
|
November 2009 |
September 2011 |
September 2011 |
December 25, 2009 |
May 17, 2013 |
|
- Rockefeller University
New York, New York, United States
|
11 |
NCT01026727 |
Terminated |
A Study to Assess the Long-term Efficacy (24 Weeks) of MPC-4326 in Combination With a 2-3 Drug OBR Relative to the Efficacy of a 3-4 Drug ARV Regimen in Treatment Experienced HIV-1 Infected Subjects Who Are Failing Current Antiretroviral Therapy |
|
- Drug: MPC-4326 plus a 2-3 drug optimized background regimen (OBR)
- Drug: 3-4 commercially available antiretroviral drugs
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of subjects with a viral load <50 copies/mL at 24 weeks in each treatment group
- The key secondary endpoint is to compare the Viral Load Decrease at 24 weeks in the two treatment arms. VLD is defined as the change from baseline log10 viral load.
|
2 |
All |
18 Years and older (Adult, Senior) |
NCT01026727 |
MPC-4326-003.01 |
|
November 2009 |
June 2010 |
June 2010 |
December 4, 2009 |
June 14, 2010 |
|
- AIDS Healthcare Foundation Research Center
Beverly Hills, California, United States - Peter Wolfe, MD, PC
Los Angeles, California, United States - Quest Clinical Research
San Francisco, California, United States - (and 22 more...)
|
12 |
NCT01023620 |
Unknown † |
HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone) |
|
- Drug: Pioglitazone
- Other: Observation
|
Interventional |
Not Applicable |
- University of Texas Southwestern Medical Center
- Takeda Pharmaceuticals North America, Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- Percent of liver fat pre/post challenge with daily Pioglitazone 45 mg
- Fine needle aspiration of fat pre/post with daily Pioglitazone 45 mg
|
24 |
Male |
18 Years and older (Adult, Senior) |
NCT01023620 |
Takeda IISR - MSA-PIO-028 |
HAL |
October 2009 |
December 2010 |
December 2010 |
December 2, 2009 |
December 2, 2009 |
|
- UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
|
13 |
NCT01015092 |
Completed |
Cardiovascular Risk Evaluation and Antiretrovirals in HIV |
- Cardiovascular Risk
- HIV Infections
|
|
Observational |
|
- King's College London
- Guy's and St Thomas' NHS Foundation Trust
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- 10 year predicted cardiovascular risk
- coronary heart disease risk
|
1024 |
All |
18 Years and older (Adult, Senior) |
NCT01015092 |
05/Q0702/156 |
CREATE1 |
June 2005 |
September 2006 |
November 2006 |
November 17, 2009 |
November 17, 2009 |
|
- Guys & ST Thomas' Foundation Hospitals
London, United Kingdom
|
14 |
NCT01017536 |
Completed Has Results |
Safety and Immunogenicity of AERAS-402 in HIV-infected, Bacillus Calmette-Guerin (BCG)-Vaccinated Adults |
- Tuberculosis
- HIV Infections
|
- Biological: AERAS-402
- Biological: Placebo
|
Interventional |
Phase 2 |
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- CD4+ Lymphocyte Count
- Change in HIV Viral Load in HIV-infected, BCG-vaccinated Adult Subjects Before and After Administration of AERAS-402 (From Day 1 to Day 182)
- Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease
|
26 |
All |
21 Years to 45 Years (Adult) |
NCT01017536 |
C-017-402 |
|
December 2009 |
March 2012 |
May 2012 |
November 20, 2009 |
September 9, 2016 |
October 13, 2014 |
- Aurum Institute
Klerksdorp, North-West, South Africa
|
15 |
NCT01027182 |
Completed |
Comparison of Concentration-time Course of Plasma and Intracellular Raltegravir in Healthy Volunteers |
- Human Immunodeficiency Virus
|
|
Interventional |
Phase 1 |
- Changi General Hospital
- National University Hospital, Singapore
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- To determine the time course and half-life of intracellular raltegravir after a single dose, and compare with plasma concentrations.
- To develop analytical methods to measure intracellular raltegravir using liquid chromatography / mass spectrometry (LCMS).
|
6 |
All |
21 Years to 65 Years (Adult) |
NCT01027182 |
RAL |
|
December 2009 |
March 2010 |
March 2010 |
December 7, 2009 |
March 19, 2010 |
|
- Changi General Hospital
Singapore, Singapore
|
16 |
NCT01014481 |
Terminated |
Appropriate Timing of HAART in Co-infected HIV/TB Patients |
- HIV Infections
- Tuberculosis
|
- Drug: tenofovir, lamivudine, efavirenz
|
Interventional |
Phase 4 |
- Bamrasnaradura Infectious Diseases Institute
- Mahidol University
- Thai Red Cross AIDS Research Centre
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- death rate
- hospitalization
- adverse events
- (and 3 more...)
|
156 |
All |
18 Years to 65 Years (Adult) |
NCT01014481 |
0435.3/1551 |
TIME |
October 2009 |
May 2011 |
May 2011 |
November 17, 2009 |
November 17, 2011 |
|
- Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health
Nonthaburi, Thailand
|
17 |
NCT01031472 |
Completed |
A Study to Assess Relative Bioavailability and Food Effect of New Formulations of GSK2248761 |
- Infection, Human Immunodeficiency Virus
|
- Drug: GSK2248761 formulation 1
- Drug: GSK2248761 reference formulation
- Drug: GSK2248761 formulation 3
- Drug: GSK2248761 formulation 2 or 4
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Plasma GSK2248761 AUC(0-infinity), AUC(0-tau), and Cmax.
- Plasma GSK2248761 t½, tlag, tmax, %AUCex, and CL/F
- Safety and tolerability parameters, including adverse events, concurrent medication, clinical laboratory screens, ECG, and vital signs assessments
|
24 |
All |
18 Years to 50 Years (Adult) |
NCT01031472 |
113391 |
|
December 2009 |
March 2010 |
March 2010 |
December 14, 2009 |
November 3, 2010 |
|
- GSK Investigational Site
Buffalo, New York, United States
|
18 |
NCT01026454 |
Completed Has Results |
Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons |
- HSV Infection
- HIV Infection
|
- Drug: acyclovir
- Drug: valacyclovir
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Mean Level of HIV-1 RNA in Plasma of Participants While on Acyclovir or Valacyclovir.
- Safety of Valacyclovir 1.5 Gram Orally Twice Daily in HIV-1 Seropositive Persons.
|
32 |
All |
18 Years and older (Adult, Senior) |
NCT01026454 |
37162-A |
ACV-VAL |
February 2010 |
November 2010 |
December 2010 |
December 4, 2009 |
April 8, 2014 |
March 5, 2014 |
- Thika Partners in Prevention
Thika, Kenya
|
19 |
NCT01028157 |
Completed |
S.T.A.R.S.: Sistas Talking About Real Solutions |
|
- Behavioral: STARS: Sistas Talking About Real Solutions
- Behavioral: General Health & Nutrition
|
Interventional |
Phase 1 |
- Emory University
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- To evaluate the efficacy of a HIV risk-reduction condition relative to general health control condition in reducing HIV-associated sexual behaviors and incident STDs.
- To evaluate the efficacy of a HIV risk-reduction condition relative to general health control condition in enhancing theoretically-derived mediators of HIV-preventive behaviors.
|
855 |
Female |
18 Years to 29 Years (Adult) |
NCT01028157 |
0524-2002 5R01MH062717 |
STARS |
October 2002 |
March 2006 |
March 2006 |
December 9, 2009 |
December 17, 2013 |
|
- Emory University, Rollins School of Public Health
Atlanta, Georgia, United States
|
20 |
NCT01019044 |
Completed |
Exploration of HIV Reservoirs |
|
- Procedure: Rectal mucosa biopsy
|
Observational |
|
- Objectif Recherche Vaccins SIDA
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml)
- Quantification of the HIV proviral DNA in the rectal mucosa biopsies and in the PPBMCs
- Quantitative, phenotypic and functional description of the long-term immune reconstitution in the rectal mucosa biopsies
- (and 2 more...)
|
11 |
All |
18 Years and older (Adult, Senior) |
NCT01019044 |
ORVACS 009 |
MUCOVIR |
May 2009 |
October 2009 |
November 2009 |
November 25, 2009 |
February 13, 2013 |
|
- Groupe Hospitalier Pitié-Salpêtrière
Paris, France
|
21 |
NCT01020045 |
Completed |
Effect of HIV Infection and Highly Active Antiretroviral Treatment (HAART) on Bone Homeostasis |
- HIV Infection
- Osteopenia
- Osteoporosis
|
|
Observational |
|
- Emory University
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- To correlate serum and B cell and T cell OPG and/or RANKL production in treatment-naïve HIV-infected patients, with indices of bone turnover and structure and with viral load.
|
120 |
All |
18 Years to 50 Years (Adult) |
NCT01020045 |
IRB00027210 R01AR059364-01 |
OPG-2 |
October 2010 |
May 2013 |
October 2015 |
November 25, 2009 |
October 19, 2015 |
|
- Grady Infectious Diseases Program Clinic
Atlanta, Georgia, United States
|
22 |
NCT01018095 |
Completed Has Results |
Trichomonas Vaginalis Recurrence Among HIV+ Women |
- Trichomonas Infections
- HIV Infections
|
|
Interventional |
Phase 4 |
- Tulane University Health Sciences Center
- National Institute of Allergy and Infectious Diseases (NIAID)
- Tulane University
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Treatment
|
- TV Culture Positive Result
|
270 |
Female |
18 Years and older (Adult, Senior) |
NCT01018095 |
543793 U19AI061972 |
|
May 2005 |
July 2009 |
August 2009 |
November 23, 2009 |
December 20, 2016 |
July 15, 2013 |
- HIV Outpatient Clinic
New Orleans, Louisiana, United States - NOAIDS
New Orleans, Louisiana, United States - Crossroads Clinic
Jackson, Mississippi, United States - (and 2 more...)
|
23 |
NCT01022476 |
Completed |
Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients |
- HIV Infection
- Liver Failure
- Evidence of Liver Transplantation
|
- Drug: Raltegravir potassium
|
Interventional |
Phase 1 Phase 2 |
- 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
|
- Pharmacokinetic parameters of raltegravir in patients with severe liver dysfunction and after a liver transplantation when combined to immunosuppressive therapy. Pharmacokinetic parameters of immunosuppressive drugs with or without raltegravir
- To assess the maintenance of the virological efficacy on HIV of raltegravir combined with two fully active molecules among NRTI (or NRTI + enfuvirtide). Follow-up over a 3-months period before and after transplantation
- To assess the safety of raltegravir before transplantation in patients with impaired liver function, and after transplantation in combination with immunosuppressive treatment
- (and 2 more...)
|
14 |
All |
18 Years and older (Adult, Senior) |
NCT01022476 |
2009-014616-36 ANRS 148 LIVERAL |
LIVERAL |
May 2010 |
May 2013 |
May 2013 |
December 1, 2009 |
July 18, 2013 |
|
- Service de Médecine Interne, Hôpital de Bicêtre
LE KREMLIN-BICETRE cedex, France
|
24 |
NCT01022905 |
Completed |
Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients |
- HIV Infection
- Rheumatic Disease
- Cancer
- (and 2 more...)
|
- Biological: Adjuvanted influenza A(H1N1) vaccines
|
Interventional |
Phase 4 |
- University Hospital, Geneva
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Antibody responses (inhibition of hemagglutination)
- Antibody responses (neutralization)
- Vaccine safety : - Solicited adverse events - graft function before / after immunization - influence of immunization on underlying disease (HIV infection, autoimmune diseases)
- T cell responses
|
1141 |
All |
6 Months and older (Child, Adult, Senior) |
NCT01022905 |
CER-09-234 |
|
November 2009 |
February 2010 |
February 2010 |
December 1, 2009 |
March 1, 2010 |
|
- University Hospitals of Geneva
Geneva, Switzerland
|
25 |
NCT01016730 |
Completed |
Bortezomib in Treating Patients With Relapsed or Refractory AIDS-Related Kaposi Sarcoma |
- AIDS-Related Kaposi Sarcoma
- HIV Infection
- Recurrent Kaposi Sarcoma
|
- Drug: Bortezomib
- Other: Laboratory Biomarker Analysis
- Other: Questionnaire Administration
|
Interventional |
Phase 1 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- MTD based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
- Change in lytic gene expression
- Changes in bortezomib in KSHV copy number in PBMC and plasma
- (and 3 more...)
|
24 |
All |
18 Years and older (Adult, Senior) |
NCT01016730 |
NCI-2012-03170 CDR0000659554 AMC-063 U01CA121947 UM1CA121947 |
|
January 22, 2010 |
January 7, 2015 |
January 7, 2015 |
November 19, 2009 |
February 20, 2018 |
|
- UC San Diego Moores Cancer Center
La Jolla, California, United States - UCLA Center for Clinical AIDS Research and Education
Los Angeles, California, United States - UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States - (and 6 more...)
|
26 |
NCT01024842 |
Terminated |
Safety and Immunogenicity of MVA.HIVconsv in HIV-1 Seropositive Adults on HAART |
|
- Biological: MVA.HIVconsv low dose
- Other: Placebo low dose
- Biological: MVA.HIVconsv high dose
- Other: Placebo high dose
|
Interventional |
Phase 1 |
- University of Oxford
- Medical Research Council
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The proportion of volunteers who develop a grade 3 or 4 local or systemic reactions
- A descriptive summary of grade 3 or 4 local and systemic events, including laboratory abnormalities
- A descriptive summary of serious adverse events, including laboratory abnormalities
- (and 6 more...)
|
19 |
All |
18 Years to 60 Years (Adult) |
NCT01024842 |
HIV-CORE 001 |
|
December 2009 |
November 2013 |
November 2013 |
December 3, 2009 |
June 8, 2016 |
|
- Weatherall Institute of Molecular Medicine
Oxford, Oxons, United Kingdom - Oxford Genitourinary Medicine
Oxford, Oxon, United Kingdom
|
27 |
NCT01019551 |
Completed |
Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients |
|
- Drug: ART Intensification
- Biological: Immunomodulation
|
Interventional |
Phase 2 |
- Objectif Recherche Vaccins SIDA
- Cytheris SA
- Merck Sharp & Dohme Corp.
- Pfizer
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Decrease from baseline in HIV proviral DNA in the PBMCs at week 56 of at least 0.5 log, as expressed as numbers of HIV DNA copies per million PBMCs
- Percentage of patients with undetectable HIV DNA (< 1 copy/million PBMCs) after 56 weeks
- Change from baseline in HIV proviral DNA in any of the sub-compartments explored (gut lymphoid tissue), as expressed as numbers of HIV DNA copies per million mononuclear cells
- (and 10 more...)
|
29 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01019551 |
ORVACS 010 |
ERAMUNE-01 |
September 2010 |
July 2012 |
February 2013 |
November 25, 2009 |
June 13, 2013 |
|
- Groupe Hospitalier Pitié-Salpêtrière
Paris, France - San Raffaele Scientific Institute
Milan, Italy - Fundacio Irsicaixa
Badalona, Spain - (and 2 more...)
|
28 |
NCT01031069 |
Active, not recruiting |
Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females |
- Infections, Papillomavirus
|
- Biological: GSK Biologicals' HPV vaccine 580299
- Biological: Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)
|
Interventional |
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Occurrence and intensity of solicited local symptoms in HIV+ subjects
- Occurrence, intensity and relationship to vaccination of solicited general symptoms in HIV+ subjects
- Occurrence, intensity and relationship to vaccination of unsolicited symptoms in HIV+ subjects
- (and 22 more...)
|
649 |
Female |
15 Years to 25 Years (Child, Adult) |
NCT01031069 |
109823 2013-003429-28 |
|
October 2010 |
January 2016 |
May 2017 |
December 14, 2009 |
December 16, 2016 |
|
- GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil - GSK Investigational Site
Ribeirão Preto, São Paulo, Brazil - GSK Investigational Site
Campinas, Brazil - (and 12 more...)
|
29 |
NCT01013987 |
Unknown † |
Maraviroc (Celsentri) With Raltegravir and Darunavir/Ritonavir for the Treatment of Triple Class Failure in Adult HIV-1 Infected Patients |
- HIV-1 Adults Patients
- AIDS
- Triple Class Failure
|
- Drug: maraviroc
- Drug: Raltegravir
- Drug: Darunavir/ritonavir
|
Interventional |
Phase 4 |
- The Huesped Foundation
- Pfizer
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients with HIV RNA levels of less than 50 copies/ml in an intent to treat analysis at week 24
- Proportion of patients with HIV RNA levels of less than 50 copies/ml at week 24 and with HIV RNA levels of less than 400 copies/ ml at weeks 24 and 48.
|
60 |
All |
21 Years and older (Adult, Senior) |
NCT01013987 |
TERCETO |
TERCETO |
February 2010 |
|
|
November 16, 2009 |
February 10, 2010 |
|
- Fundación Huésped
Ciudad de Buenos Aires, Argentina
|
30 |
NCT01017172 |
Unknown † |
Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adult Patients |
- HIV-1 Infection
- Cancer
- Immunosuppression
|
|
Interventional |
Phase 4 |
- Goethe University
- HIVCENTER
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- To investigate the immunogenicity via anti-hemagglutinin responses following an adjuvanted H1N1 vaccination in HIV-positive and immunosuppressed adult patients
- To evaluate the effect of pre-existing anti-influenza immunity and recent history of seasonal influenza and H5N1 vaccination on seroresponses to the H1N1 influenza vaccine
- To evaluate potential adverse reactions of the H1N1 vaccine
|
500 |
All |
18 Years and older (Adult, Senior) |
NCT01017172 |
JWG11.2009 |
|
November 2009 |
March 2010 |
March 2010 |
November 20, 2009 |
November 20, 2009 |
|
- Hivcenter
Frankfurt, Germany
|
31 |
NCT01024764 |
Completed |
Observational Study of the Preventive Trial With HIV-1 Tat Protein |
|
|
Observational |
|
- Istituto Superiore di Sanità
|
Other |
- Time Perspective: Prospective
|
- To evaluate the persistence of specific immune responses, volunteers will be monitored for anti-Tat specific antibodies, anti-Tat proliferative response and in vitro γIFN and IL-4 production in response to Tat (Elispot).
- To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials.
|
5 |
All |
18 Years to 50 Years (Adult) |
NCT01024764 |
ISS OBS P-001 |
ISS OBS P-001 |
November 2007 |
|
December 2010 |
December 3, 2009 |
March 1, 2011 |
|
- San Raffaele Hospital
Milan, Italy - I.R.C.C.S. Spallanzani Hospital
Rome, Italy - Istituto Dermatologico S. Gallicano-IRCCS
Rome, Italy
|