1 |
NCT00955006 |
Completed |
Immune Response to an HIV DNA Plasmid Vaccine Prime Followed by Adenovirus Boost in HIV-uninfected Individuals |
|
- Biological: VRC-HIVDNA-016-00-VP
- Biological: VRCHIVADV014-00-VP
|
Interventional |
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- HIV-specific T-cell response rates detected in specimens collected from the rectum, semen, or cervix as assessed by IFN-γ ELISpot assay and/or flow cytometry
- Local and systemic reactogenicity signs and symptoms, adverse events and severe adverse events.
- Induction of mucosal homing markers on HIV-specific T-cells as assessed by flow cytometric assays of peripheral blood samples
- (and 4 more...)
|
17 |
All |
18 Years to 50 Years (Adult) |
NCT00955006 |
HVTN 076 10625 |
|
May 2011 |
September 2013 |
November 22, 2017 |
August 7, 2009 |
March 7, 2018 |
|
- Seattle Vaccine and Prevention CRS
Seattle, Washington, United States
|
2 |
NCT00951249 |
Completed |
Feasibility Study of a Multi-Component Intervention for Black Men Who Have Sex With Men |
|
- Behavioral: Referral of Partners
- Behavioral: Screening for STIs and counseling
- Behavioral: Peer health care system navigators
- Behavioral: Enhanced counseling
|
Interventional |
Not Applicable |
- HIV Prevention Trials Network
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute on Drug Abuse (NIDA)
- (and 2 more...)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of participants enrolled at each city
- Proportion of participants who agree to HIV testing
- Proportion of participants who agree to STI testing
- (and 16 more...)
|
1553 |
Male |
18 Years and older (Adult, Senior) |
NCT00951249 |
HPTN 061 1U01AI068619 |
|
July 2009 |
December 2011 |
December 2011 |
August 4, 2009 |
May 11, 2012 |
|
- UCLA Vine Street CRS
Los Angeles, California, United States - San Francisco Vaccine and Prevention CRS
San Francisco, California, United States - George Washington University
Washington, District of Columbia, United States - (and 5 more...)
|
3 |
NCT00951743 |
Unknown † |
Safety and Efficacy of ADAPTAVIR's Ability to Eliminate Treatment-Resistant Infectious Virus in Peripheral Blood Mononuclear Cells (PBMCs) |
|
- Drug: Adaptavir (monomeric DAPTA)
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- To assess the safety & toxicity of mDAPTA in HIV infected individuals with suppressed viral loads on HAART treatment & assess the proportion of study participants achieving PMBC viral culture negative status at 24weeks.
- Virological and Immunological outcome measures
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT00951743 |
RAPID Laboratories 001 |
|
July 2009 |
May 2010 |
July 2010 |
August 4, 2009 |
August 11, 2009 |
|
- Whitman Walker Clinic
Washington, District of Columbia, United States
|
4 |
NCT00955968 |
Completed Has Results |
IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women |
|
- Drug: Highly active antiretroviral therapy (HAART)
|
Interventional |
Phase 4 |
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- National Institute of Allergy and Infectious Diseases (NIAID)
- 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: Treatment
|
- Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death
- Incidence Rate of AIDS - Defining Illness
- Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event
- (and 13 more...)
|
1653 |
Female |
18 Years and older (Adult, Senior) |
NCT00955968 |
IMPAACT 1077HS U01AI068632 |
|
January 2010 |
August 2016 |
August 2016 |
August 10, 2009 |
March 20, 2018 |
February 16, 2018 |
- University of Southern California MCA Center (5048)
Alhambra, California, United States - David Geffen School of Medicine at UCLA (5112)
Los Angeles, California, United States - UCSD Mother-Child-Adolescent HIV Program (4601)
San Diego, California, United States - (and 47 more...)
|
5 |
NCT00977301 |
Completed |
Interaction Between Fosamprenavir/Ritonavir and a Single-dose Olanzapine (FORZA) |
|
- Drug: fosamprenavir/ritonavir
- Drug: olanzapine
|
Interventional |
Phase 1 |
- Radboud University
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- olanzapine concentrations
- adverse events
|
24 |
All |
18 Years to 55 Years (Adult) |
NCT00977301 |
UMCN-AKF 08.04 |
FORZA |
November 2009 |
August 2010 |
August 2010 |
September 15, 2009 |
January 10, 2011 |
|
- CRCN, Radboud Universtity Nijmegen Medical Centre
Nijmegen, Netherlands
|
6 |
NCT00961883 |
Completed |
Safety of and Immune Response to Prime/Boost Vaccine Regimens in Healthy, HIV-1 Uninfected, Ad5 Seronegative Adults |
|
- Biological: NYVAC-B
- Biological: Placebo
- Biological: rAd5
|
Interventional |
Phase 1 |
- HIV Vaccine Trials Network
- National Institute of Allergy and Infectious Diseases (NIAID)
- EuroVacc Foundation
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Prevention
|
- Local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse events and serious adverse events meeting expedited adverse (EAE) criteria
- Magnitude and frequency of T-cell response as measured by ELISpot and/or intracellular cytokine staining (ICS) assay 2 weeks post 4th vaccination
|
80 |
All |
18 Years to 45 Years (Adult) |
NCT00961883 |
HVTN 078 5U01AI068614 |
|
August 2009 |
January 2013 |
|
August 19, 2009 |
September 6, 2013 |
|
- BH10/513
Lausanne, Switzerland - BT06/614
Lausanne, Switzerland
|
7 |
NCT00949234 |
Completed Has Results |
Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV |
- HIV Prevention
- HIV Infections
|
- Drug: tenofovir + emtricitabine, lopinavir/ritonavir
|
Interventional |
Phase 2 |
- University of California, Los Angeles
- Los Angeles County Department of Public Health
- AIDS Project Los Angeles
- (and 2 more...)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit
|
267 |
All |
18 Years and older (Adult, Senior) |
NCT00949234 |
PQUAD |
|
March 2010 |
June 2010 |
August 2011 |
July 30, 2009 |
December 18, 2017 |
December 18, 2017 |
- L.A. Gay & Lesbian Center
Los Angeles, California, United States - OASIS Clinic
Los Angeles, California, United States
|
8 |
NCT00963963 |
Completed |
Reducing HIV Risks in African American Teens |
|
- Behavioral: Healthy Futures parent education
|
Interventional |
Not Applicable |
- Education Development Center, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
|
1200 |
All |
11 Years and older (Child, Adult, Senior) |
NCT00963963 |
5R01HD054297 |
|
April 2006 |
April 30, 2013 |
April 30, 2013 |
August 24, 2009 |
February 1, 2018 |
|
- Education Development Center
Newton, Massachusetts, United States
|
9 |
NCT00964327 |
Completed |
TMC114-C201: A Study to Determine the Antiviral Activity of TMC114 in Patients With Multiple Protease Inhibitor (PI) Resistant Human Immunodeficiency Virus (HIV) Strains |
|
|
Interventional |
Phase 2 |
- Tibotec Pharmaceuticals, Ireland
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the antiviral activity of TMC114.
- nadir of viral load
- Pharmacokinetics (PK) / Pharmacodynamics (PD): Plasma concentration of TMC114 and efficacy and safety data will be analyzed to find relationships between PK and PD.
- CD4 count
|
42 |
All |
18 Years and older (Adult, Senior) |
NCT00964327 |
CR006718 |
|
August 2001 |
October 2003 |
October 2003 |
August 24, 2009 |
May 19, 2011 |
|
|
10 |
NCT00959361 |
Completed |
Evaluation of Effectiveness of Pharmaceutical Care on the Adherence of HIV-Positive Patients to Antiretroviral Therapy |
|
- Behavioral: pharmaceutical care
|
Interventional |
Not Applicable |
- Hospital de Clinicas de Porto Alegre
- Federal University of Rio Grande do Sul
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Relative risk for adherence to the antiretroviral treatment among HIV-positive patients who receive Pharmaceutical Care and the ones that do not receive Pharmaceutical
|
332 |
All |
18 Years and older (Adult, Senior) |
NCT00959361 |
2003164 |
PC-HIV |
June 2006 |
May 2009 |
May 2009 |
August 14, 2009 |
September 29, 2009 |
|
- Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil
|
11 |
NCT00961272 |
Completed |
Evaluating the Pharmacokinetics of 400 mg Oral Dose of Raltegravir in HIV-Infected Pre-Menopausal Women |
|
|
Observational |
|
- Kristine Patterson, MD
- Merck Sharp & Dohme Corp.
- University of North Carolina, Chapel Hill
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To describe the pharmacokinetics of raltegravir in cervicovaginal secretions as compared to blood plasma at steady-state in six HIV-positive women.
|
6 |
Female |
18 Years to 49 Years (Adult) |
NCT00961272 |
09-0889 |
|
July 2009 |
February 2010 |
February 2010 |
August 18, 2009 |
February 28, 2014 |
|
- The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
|
12 |
NCT00946595 |
Completed |
Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients |
|
- Drug: efavirenz/emtricitabin/tenofovir
- Drug: lopinavir/ritonavir
|
Interventional |
Phase 2 Phase 3 |
- French National Agency for Research on AIDS and Viral Hepatitis
- Abbott
- Gilead Sciences
- French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients without treatment failure at Week 96
- Proportion of patients with plasma HIV-1 RNA below 50 cp/mL at all time points during the trial
- Proportion of patients with plasma HIV-1 RNA below 50 cp/mL at Week 96
- (and 12 more...)
|
420 |
All |
18 Years and older (Adult, Senior) |
NCT00946595 |
2009-009776-13 ANRS 140 DREAM |
ANRS 140 DREAM |
November 2009 |
July 2013 |
January 2014 |
July 27, 2009 |
June 24, 2014 |
|
- Service des maladies infectieuses et tropicales Hopital Saint-Antoine
Paris, France
|
13 |
NCT00959413 |
Completed |
Assessing HIV-Related Oral Mucosal Disease and Using Saliva to Measure Viral Load |
|
|
Observational |
|
- AIDS Clinical Trials Group
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- Presumptive clinical diagnoses of oral mucosal diseases
- HIV-1 viral load in throat wash.
- HIV-1 viral load in plasma
- (and 8 more...)
|
328 |
All |
18 Years and older (Adult, Senior) |
NCT00959413 |
ACTG A5254 1U01AI068636 |
|
September 2009 |
September 2012 |
September 2012 |
August 14, 2009 |
March 18, 2015 |
|
- Ucsf Aids Crs (801)
San Francisco, California, United States - The Ponce de Leon Ctr. CRS (5802)
Atlanta, Georgia, United States - NY Univ. HIV/AIDS CRS (401)
New York, New York, United States - (and 3 more...)
|
14 |
NCT00959088 |
Completed |
Faster Identification of TB and Evaluation of Drug Resistance in HIV-infected People |
|
|
Observational |
|
- AIDS Clinical Trials Group
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- GenoType Direct line probe assay result (MTB-positive or negative) and conventional mycobacterial culture assay result (MTB-positive or negative) on direct sputum samples
- GenoType Direct line probe assay results on direct sputum samples
- GenoType MTBDR Plus line probe assay results on cultured and direct sputum samples
- (and 6 more...)
|
641 |
All |
13 Years and older (Child, Adult, Senior) |
NCT00959088 |
ACTG A5255 1U01AI068636 FASTER |
FASTER |
August 2009 |
June 2012 |
June 2012 |
August 14, 2009 |
April 11, 2013 |
|
- Instituto de Pesquisa Clinica Evandro Chagas (12101)
Rio de Janeiro, Brazil - Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301)
Lima, Peru - Wits HIV CRS
Johannesburg, Gauteng, South Africa
|
15 |
NCT00954863 |
Unknown † |
Genotypic Resistant HIV Strains in Taiwan |
|
|
Observational |
|
- National Taiwan University Hospital
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT00954863 |
200905045R |
|
August 2009 |
July 2010 |
July 2010 |
August 7, 2009 |
September 29, 2009 |
|
- R424, Examination Building, National Taiwan University Hospital
Taipei, Taiwan
|
16 |
NCT00958100 |
Completed |
Raltegravir Switch for Toxicity or Adverse Events |
- HIV/AIDS
- Antiretroviral Therapy
- HIV Infections
|
- Drug: tenofovir emtricitabine raltegravir
- Drug: Lamivudine Abacavir Raltegravir
- Drug: Abacavir free
|
Interventional |
Phase 2 |
- Catholic University of the Sacred Heart
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To verify the persistent control of the virus replication after the simplification to tenofovir+emtricitabine+raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any previous virological failure
- Time to virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) at survival analysis
- Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis
- (and 6 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT00958100 |
2009−014316−35 |
RaSTA |
August 2009 |
November 2010 |
December 2010 |
August 13, 2009 |
February 4, 2015 |
|
- Policlinico A. Gemelli
Rome, Italy
|
17 |
NCT00959894 |
Completed Has Results |
Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection |
|
- Drug: Etravirine (Intelence)
- Drug: Truvada
|
Interventional |
Phase 2 |
- University of North Carolina, Chapel Hill
- Janssen Pharmaceuticals
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Antiretroviral Activity of Etravirine 400 mg Given Once Daily, With Fixed-dose Truvada Once Daily, Among Treatment-naïve HIV-1 Infected Adults as Measured by the Percentage of Participants With HIV RNA < 50 Copies/mL at Week 24
- The Proportion of Participants With HIV RNA <50 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
- The Proportion of Participants With HIV RNA <50 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
- (and 22 more...)
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT00959894 |
08-2070 |
|
September 2009 |
February 2014 |
May 2014 |
August 17, 2009 |
June 6, 2016 |
May 13, 2015 |
- The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States - Carolinas Medical Center
Charlotte, North Carolina, United States - Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
|
18 |
NCT00947947 |
Completed |
Computerized HIV/Sexually Transmitted Disease (STD) Prevention Program |
- Acquired Immunodeficiency Syndrome
- HIV Infections
|
- Behavioral: Tailored Information Program for Safer Sex
|
Interventional |
Phase 2 |
- University of North Carolina, Chapel Hill
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Single (Investigator)
- Primary Purpose: Prevention
|
- Condom use with main and casual sexual partners
|
274 |
All |
18 Years to 29 Years (Adult) |
NCT00947947 |
R34MH077507 |
TIPSS |
February 2010 |
May 2012 |
May 2012 |
July 28, 2009 |
November 15, 2013 |
|
- Specialty Clinic, Louisville Metro Health Department
Louisville, Kentucky, United States
|
19 |
NCT00951795 |
Withdrawn |
Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts |
- HIV Infection
- AIDS
- HIV Infections
|
|
Observational |
|
- Biosite
- Inverness Medical Innovations
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
0 |
All |
12 Years and older (Child, Adult, Senior) |
NCT00951795 |
BSTE-0510 |
|
September 2009 |
September 2009 |
September 2009 |
August 4, 2009 |
July 21, 2015 |
|
- Fenway Community Health
Boston, Massachusetts, United States - University of North Carolina
Chapel Hill, North Carolina, United States - Miriam Hospital
Providence, Rhode Island, United States
|
20 |
NCT00944541 |
Completed |
Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration |
- HIV Infection
- HIV Infections
|
|
Interventional |
Phase 2 |
- French National Agency for Research on AIDS and Viral Hepatitis
- Pfizer
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluation of maraviroc intensification during 24 weeks in HIV infected patients with insufficient immune restoration despite controlled viral load
- Maraviroc efficacy at W24 (virological and immunological efficacy); Durability of maraviroc efficacy between W24 & W36; Cmin of maraviroc and other molecules at W4,12,24; Evaluation of the safety of maraviroc between W0 and W36.
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT00944541 |
2009-011171-76 ANRS 145 MARIMUNO |
145 MARIMUNO |
September 2009 |
August 2010 |
January 2011 |
July 23, 2009 |
December 22, 2011 |
|
- French National Agency for Research on AIDS and Viral Hepatits
Paris, France
|
21 |
NCT00947271 |
Completed Has Results |
Reducing Sexual Risk Behaviors and Improving Health for People at a Sexually Transmitted Infection Clinic |
- HIV
- Sexually Transmitted Diseases
- HIV Infections
|
- Behavioral: DVD 1
- Behavioral: DVD 2
|
Interventional |
Phase 3 |
- The Miriam Hospital
- National Institute of Mental Health (NIMH)
- University of Rochester
- (and 2 more...)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Sexual Partners, 3 Months Post Intervention
- Number of Sexual Partners, 6 Months Post Intervention
- Number of Sexual Partners, 9 Months Post Intervention
- (and 2 more...)
|
1010 |
All |
16 Years and older (Child, Adult, Senior) |
NCT00947271 |
R01MH068171-06 PCC: DAHBR 9A-ASPQ |
|
October 2009 |
June 2014 |
June 2014 |
July 28, 2009 |
September 17, 2014 |
September 17, 2014 |
- Monroe County Health Department
Rochester, New York, United States
|
22 |
NCT00947609 |
Completed |
Improving Latent Tuberculosis (TB) Diagnosis in Thai Children |
- Latent Tuberculosis
- HIV Infections
|
|
Observational |
|
- South East Asia Research Collaboration with Hawaii
- Columbia University
- New York Blood Center
- (and 2 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
158 |
All |
2 Months to 16 Years (Child) |
NCT00947609 |
SEARCH TB Px |
TB Px |
August 2009 |
December 2011 |
December 2011 |
July 28, 2009 |
June 6, 2012 |
|
- HIV Netherlands Australia Thailand (HIV-NAT) Research Organization
Bangkok, Thailand - Queen Sirikit National Institute of Child Health
Bangkok, Thailand
|
23 |
NCT00963235 |
Completed Has Results |
Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS |
- HIV Infections
- Pneumococcal Infections
|
- Biological: 13-valent pneumococcal conjugate vaccine
- Procedure: Blood draw
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
- Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
- Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
- (and 4 more...)
|
331 |
All |
18 Years and older (Adult, Senior) |
NCT00963235 |
6115A1-3017 B1851028 |
|
November 2009 |
May 2012 |
May 2012 |
August 21, 2009 |
June 10, 2013 |
June 10, 2013 |
- Pfizer Investigational Site
San Francisco, California, United States - Pfizer Investigational Site
Aurora, Colorado, United States - Pfizer Investigational Site
Washington, District of Columbia, United States - (and 12 more...)
|
24 |
NCT00946556 |
Completed |
Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix |
- Herpes Simplex Type Two Infection
- HIV Infections
|
- Drug: Valacyclovir
- Drug: Placebo
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of CD4+ T cells on a cervical cytobrush.
- Number of immature dendritic cells on a cervical cytobrush
- Proinflammatory cytokine/chemokine levels in cervicovaginal secretions
|
30 |
Female |
18 Years and older (Adult, Senior) |
NCT00946556 |
HET-85518 |
|
April 2010 |
May 2011 |
May 2011 |
July 27, 2009 |
March 22, 2012 |
|
- Women's Health In Women's Hands
Toronto, Ontario, Canada
|
25 |
NCT00962780 |
Completed Has Results |
Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine |
- HIV Infections
- Pneumococcal Infections
|
- Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
- Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
- Procedure: Blood draw
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
- Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
- Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
- (and 2 more...)
|
303 |
All |
6 Years and older (Child, Adult, Senior) |
NCT00962780 |
6115A1-3002 B1851021 |
|
March 2010 |
April 2013 |
April 2013 |
August 20, 2009 |
November 17, 2014 |
November 17, 2014 |
- Pfizer Investigational Site
Bucuresti, Romania - Pfizer Investigational Site
Bucuresti, Romania - Pfizer Investigational Site
Constanta, Romania - (and 8 more...)
|
26 |
NCT00951028 |
Completed |
Therapy Targeting Depression and HIV Treatment Adherence (The TRIAD Study) |
- HIV
- Depression
- HIV Infections
|
- Behavioral: Cognitive behavioral therapy (CBT) for adherence and depression (CBT-AD)
- Behavioral: Life-steps adherence treatment
- Behavioral: Information and supportive psychotherapy (ISP) for adherence and depression (ISP-AD)
|
Interventional |
Not Applicable |
- Massachusetts General Hospital
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- changes in HIV medication adherence, as measured by electronic medication event monitoring system (MEMS) pill-cap scores
- changes in Severity of depression, as assessed on the Montgomery-Asberg Depression Rating Scale (MADRS) by a blinded independent assessor
- changes in depression, as measured by the blinded assessor CGI rating
- (and 3 more...)
|
240 |
All |
18 Years and older (Adult, Senior) |
NCT00951028 |
R01MH084757 1R01MH084757-01A1 DAHBR 9A-ASGA |
|
September 2008 |
April 2013 |
April 2013 |
August 4, 2009 |
June 18, 2013 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States - Fenway Community Health Center
Boston, Massachusetts, United States - Butler Hospital
Providence, Rhode Island, United States - The Miriam Hospital
Providence, Rhode Island, United States
|
27 |
NCT00952874 |
Completed |
Molecular Biology of Anal Cancer in HIV-Positive Patients |
|
|
Observational |
|
- University Hospital, Geneva
- University of Lausanne Hospitals
- University of Zurich
|
Other |
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
|
|
30 |
All |
20 Years to 80 Years (Adult, Senior) |
NCT00952874 |
SCCA/HIV |
|
July 2009 |
January 2010 |
June 2010 |
August 6, 2009 |
June 25, 2010 |
|
- University Hospital Geneva
Genève, Switzerland
|
28 |
NCT00945282 |
Completed |
Safety and Tolerability Study to Evaluate Lower Dose of GSK2248761 in Antiretroviral Treatment-Naive HIV-1 Infected Adults. |
- Infection, Human Immunodeficiency Virus
|
- Drug: GSK2248761
- Drug: Lopinavir/ritonavir
- Drug: HAART
- Drug: Placebo
|
Interventional |
Phase 2 |
- ViiV Healthcare
- GlaxoSmithKline
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Safety and tolerability parameters, including adverse event, clinical laboratory, electrocardiogram (EGC) and vital sign assesssments.
- Change from baseline through Day 8 in plasma HIV-1 RNA.
- GSK2248761 PK parameters following dose administration on Day 1 and Day 7.
- (and 4 more...)
|
8 |
All |
21 Years to 65 Years (Adult) |
NCT00945282 |
113020 |
|
October 2009 |
December 2009 |
December 2009 |
July 24, 2009 |
June 7, 2013 |
|
|
29 |
NCT00960622 |
Completed Has Results |
Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects |
|
- Drug: Truvada
- Drug: Combivir
- Drug: Trizivir
|
Interventional |
Phase 4 |
- St. Luke's-Roosevelt Hospital Center
- Gilead Sciences
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Peak Oxygen Uptake.
|
17 |
All |
18 Years and older (Adult, Senior) |
NCT00960622 |
TRU |
TRU |
August 2006 |
July 2009 |
July 2009 |
August 18, 2009 |
March 4, 2013 |
March 4, 2013 |
- St. Luke's-Roosevelt Hospital Center
New York, New York, United States
|
30 |
NCT00950859 |
Completed Has Results |
A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir |
- Infection, Human Immunodeficiency Virus
|
- Drug: GSK1349572 (Cohort I)
- Drug: GSK1349572 (Cohort II)
|
Interventional |
Phase 2 |
- ViiV Healthcare
- GlaxoSmithKline
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants Who Achieved HIV-1 RNA <400 Copies (c)/Milliliter (mL) or at Least 0.7 log10 c/mL Below Their Baseline Value at Day 11
- Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion
- Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.
- (and 15 more...)
|
51 |
All |
18 Years and older (Adult, Senior) |
NCT00950859 |
112961 |
|
August 2009 |
November 2010 |
January 2015 |
August 3, 2009 |
December 4, 2015 |
October 21, 2013 |
- GSK Investigational Site
Phoenix, Arizona, United States - GSK Investigational Site
Long Beach, California, United States - GSK Investigational Site
San Francisco, California, United States - (and 23 more...)
|
31 |
NCT00959166 |
Completed |
Study to Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection - A Positron Emission Tomography (PET) Study |
- Acute Hepatitis C
- HIV
- HIV Infections
|
|
Observational |
|
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection
- Association of CNS metabolite ratios and neurocognitive performance with acute HCV and HIV infection. Association between patient characteristics and 11C-labelled PK11195 uptake using PET, CNS metabolite ratios and neurocognitive performance.
|
24 |
Male |
25 Years and older (Adult, Senior) |
NCT00959166 |
09/H0712/17 |
|
June 2009 |
June 2011 |
September 2011 |
August 14, 2009 |
February 22, 2016 |
|
- St Mary's Hospital
London, United Kingdom
|
32 |
NCT00959699 |
Completed Has Results |
A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4) |
- HIV Infections
- Hepatitis C
- HCV Infection
|
- Drug: PegIFN-2b
- Drug: RBV
- Drug: Placebo to Boceprevir
- Drug: Boceprevir
|
Interventional |
Phase 2 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication
- Percentage of Participants Achieving SVR24 Among Randomized Participants Who Received At Least One Dose of Boceprevir (Experimental) or Placebo (Control)
- Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24
- (and 3 more...)
|
99 |
All |
18 Years to 65 Years (Adult) |
NCT00959699 |
P05411 MK-3034-025 |
|
November 2009 |
May 2012 |
October 2012 |
August 17, 2009 |
April 7, 2017 |
August 30, 2013 |
|
33 |
NCT00951015 |
Completed Has Results |
A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects |
- Infection, Human Immunodeficiency Virus
|
- Drug: GSK1349572
- Drug: efavirenz
|
Interventional |
Phase 2 |
- ViiV Healthcare
- Shionogi
- GlaxoSmithKline
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 16
- Viral Change Over the Initial 2 Weeks of Treatment
- Change From Baseline in HIV-1 RNA at the Indicated Time Points
- (and 19 more...)
|
208 |
All |
18 Years and older (Adult, Senior) |
NCT00951015 |
112276 |
ING112276 |
July 30, 2009 |
February 26, 2010 |
December 22, 2016 |
August 3, 2009 |
January 16, 2018 |
November 11, 2013 |
- GSK Investigational Site
Phoenix, Arizona, United States - GSK Investigational Site
Bakersfield, California, United States - GSK Investigational Site
Long Beach, California, United States - (and 32 more...)
|
34 |
NCT00958815 |
Completed |
Human Atherosclerotic Plaque Inflammation Imaged Using PDG-PET/CT |
- Insulin Resistance
- Atherosclerosis
- Cardiovascular Disease
- (and 2 more...)
|
|
Observational |
|
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Standard uptake values (SUV) for 18Fluoro-deoxyglucose in the carotid vessels and aorta of HIV-infected people with cardiovascular disease risk factors and compared to the same in HIV-seronegative people with no cardiovascular disease risk factors.
- Carotid intima media thickness measures will be compared to carotid 18FDG SUV.
|
14 |
All |
35 Years to 60 Years (Adult) |
NCT00958815 |
18FDG (completed) DK-020579 |
|
March 2009 |
March 2010 |
March 2010 |
August 13, 2009 |
June 26, 2012 |
|
- Washington University School of Medicine
St.Louis, Missouri, United States
|
35 |
NCT00955591 |
Completed |
Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men |
- Anal Cancer
- Nonneoplastic Condition
- Precancerous Condition
|
|
Interventional |
Not Applicable |
- Jonsson Comprehensive Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab
|
48 |
Male |
18 Years and older (Adult, Senior) |
NCT00955591 |
CDR0000643881 P30CA016042 UCLA-0901062 IRB# 09-01-062-02 |
|
March 12, 2009 |
December 12, 2011 |
October 14, 2016 |
August 10, 2009 |
February 17, 2017 |
|
- UCLA
Los Angeles, California, United States
|