Clinical trials: HIV/AIDS
Human Immunodeficiency Virus
3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals
The proposed study is a phase 1, open label, single arm study to evaluate the safety, pharmacokinetics and antiviral activity of single intravenous infusions of 3BNC117-LS and 10-1074-LS, each monoclonal antibody (mAb) dosed at…
- Trial name
- NCT04250636
- Testing
- 3BNC117-LS, 10-1074-LS
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Rockefeller University
HIV Infections, Episodic Substance Use
Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM)
The purpose of this study is to determine if persons randomized to receive adapted Personalized Cognitive Risk-reduction Counseling (PCC) will report greater reductions in unprotected anal sex behavior compared with persons who…
- Trial name
- NCT01279044
- Testing
- Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC), Standard HIV testing with information only
- Where
- United States
- Volunteers
- 385 people, healthy volunteers welcome
- Sponsor
- San Francisco Department of Public Health
Infection, Human Immunodeficiency Virus, HIV Infections
An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Participants (Gemini 2)
This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors (tenofovir…
- Trial name
- NCT02831764
- Testing
- Dolutegravir (DTG), Lamivudine (3TC), Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)
- Where
- 105 sites in United States, Argentina and 16 more
- Volunteers
- 722 people
- Sponsor
- ViiV Healthcare
Cervical Cancer, Nonneoplastic Condition
Vaccine Therapy in Preventing HPV in HIV-Positive Women in India
RATIONALE: Vaccines made from virus proteins may help the body build an effective immune response to prevent cervical cancer. PURPOSE: This pilot study is looking at the side effects of a human papillomavirus vaccine and how well…
- Conditions
- Cervical Cancer, Nonneoplastic Condition, Precancerous Condition
- Trial name
- NCT00667563
- Testing
- quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, DNA analysis, polymerase chain reaction
- Where
- India
- Volunteers
- 150 people
- Sponsor
- AIDS Malignancy Consortium
Substance Abuse, Domestic Violence
Hispanic Men Building Respect Education and Safety/ HoMBRES Manteniendo Respeto, Educacion y Seguridad.
The overall objective of this project is to adapt and enhance HoMBReS (Hispanic Men Building Respect, Education, and Safety within Families /Hombres Manteniendo Respeto, Educacion y Seguridad de Familia), a Center for Disease…
- Conditions
- Substance Abuse, Domestic Violence, HIV/AIDS
- Trial name
- HoMBRES (NCT03730987)
- Testing
- HoMBReS intervention, Families Talking Together (FTT), Diabetes Prevention Intervention
- Where
- United States
- Volunteers
- 244 people, healthy volunteers welcome
- Sponsor
- University of Miami
HIV Infections
Pharmacokinetics and Metabolism of 14 Carbon [14C]-GSK3640254
This is an open-label, single-center, single group, non-randomized, two-period, single sequence, mass balance study which will enroll 6 healthy male participants.
- Trial name
- NCT04507321
- Testing
- GSK3640254 Oral tablet, [14C]-GSK3640254 intravenous infusion, [14C]-GSK3640254 powder
- Where
- United Kingdom
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV
Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140
This is a Phase 2b/3, multi-center, two part study, designed to evaluate the efficacy, safety, and tolerability of PRO 140 in conjunction with existing ART (failing regimen) for one week and Optimized Background Therapy (OBT) for…
- Trial name
- PRO140 (NCT02483078)
- Testing
- PRO 140, Optimized Background Regimen
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 52 people
- Sponsor
- CytoDyn, Inc.
HIV Seropositivity, Metabolic Syndrome
Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir
This study will provide data on the switch from a protease inhibitor or efavirenz to the new formulation of raltegravir (RAL) dosed once daily.
- Conditions
- HIV Seropositivity, Metabolic Syndrome, Fatty Liver
- Trial name
- OBERAL (NCT03374358)
- Testing
- Raltegravir
- Where
- Finland
- Volunteers
- 45 people
- Sponsor
- Helsinki University Central Hospital
HIV Infections
Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects
A prospective, randomized, open-label pilot study to assess virologic suppression and immunologic recovery associated with a two-drug antiretroviral regimen of Raltegravir and the protease inhibitor lopinavir/ritonavir (LPV/r)…
- Trial name
- HIV (NCT00654147)
- Testing
- Raltegravir & Lopinavir/ritonavir, Raltegravir and emtricitabine/tenofovir
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Margaret A. Fischl, M.D.
HIV Infections
VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients
The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients…
- Trial name
- NCT00561925
- Testing
- nevirapine IR, nevirapine XR
- Where
- 202 sites in United States, Argentina and 19 more
- Volunteers
- 1,068 people
- Sponsor
- Boehringer Ingelheim
Influenza
H1N1 Vaccine at Two Dose Levels in HIV Positive Adults
The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot in persons infected with human immunodeficiency virus (HIV).
- Trial name
- NCT00992433
- Testing
- Inactivated Influenza H1N1 vaccine
- Where
- 6 sites in United States
- Volunteers
- 192 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
China Antiretroviral Treatment Adherence for Life
This study focuses on collecting and analyzing quantitative data related to adherence to antiretroviral treatment from patients in Dali, China, over a one-year time-frame and generating preliminary data on an intervention…
- Trial name
- AFL (NCT00661258)
- Testing
- Electronic drug monitoring feedback data
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Boston University
HIV Infections, Tobacco Use Cessation
Tobacco Cessation Tailored to Patients Living With HIV (PLWH) in Brazil
The overall goal of this feasibility study is to make adaptations to these evidence-based approaches in collaboration with PLWH and health care providers working with this population, and develop, implement, and evaluate the…
- Trial name
- NCT05560243
- Testing
- Tobacco cessation
- Where
- Brazil
- Volunteers
- 56 people
- Sponsor
- University of Alabama at Birmingham
HIV Infections, Meningitis
Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth
Bacterial meningitis infection is common in youth 2 to 24 years of age in the United States. This disease can be treated by antibiotics, but mortality rates associated with meningitis of up to 53% have been estimated.
- Trial name
- NCT00459316
- Testing
- Quadrivalent meningococcal conjugate vaccine
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 384 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous or…
- Trial name
- NCT04212091
- Testing
- PGT121.414.LS, VRC07-523LS
- Where
- 5 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Healthy
Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.
The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential substitute for BCG vaccination. BCG vaccination has indeed demonstrated its major limitation in inducing protection against tuberculosis…
- Trial name
- MTBVAC (NCT02013245)
- Testing
- MTBVAC live vaccine, Commercially available BCG live vaccine
- Where
- Switzerland
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
HIV
Combination Therapy With VRC01 and 10-1074 in HIV-Infected Individuals Undergoing Sequential Treatment Interruptions
Background: A daily drug combination can keep human immunodeficiency virus (HIV) levels low for a long time. But if this combination antiretroviral therapy (ART) stops, HIV levels go back up.
- Trial name
- NCT03831945
- Testing
- VRC-HIVMAB060-00-AB (VRC01), 10-1074
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hepatitis C, Chronic, HIV Infection
Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection
The main objective is to evaluate the hepatic safety of raltegravir when compared to efavirenz, both in combination with tenofovir and emtricitabine as first-line HIV treatment in patients with HIV and hepatitis C coinfection.
- Trial name
- NCT01147107
- Testing
- Raltegravir, Efavirenz
- Where
- 2 sites in Vietnam
- Volunteers
- 80 people
- Sponsor
- University of Hawaii
HIV Infections
Clinical Trial of CNS-targeted HAART (CIT2)
CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI).
- Trial name
- NCT00624195
- Testing
- FDA Approved Antiretroviral Therapy (see list below)
- Where
- 5 sites in United States
- Volunteers
- 59 people
- Sponsor
- University of California, San Diego
HIV Infections
Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
This study will evaluate the safety and efficacy of the long-acting injectable agent cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP) in…
- Trial name
- NCT03164564
- Testing
- Oral CAB, Oral TDF/FTC, CAB LA
- Where
- 20 sites in Botswana, Eswatini and 5 more
- Volunteers
- 3,224 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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