Clinical trials: HIV-infection/AIDS
HIV Infections, Multi-Antiviral Resistance
A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV…
- Trial name
- PROMISE-US (NCT05388474)
- Testing
- No ibalizumab or Pre-ibalizumab treatment, On ibalizumab treatment
- Where
- 36 sites in United States
- Volunteers
- 168 people
- Sponsor
- Theratechnologies
Cytomegalovirus Infections, HIV Infections
A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria
To determine the safety, tolerance, and potential in vivo antiviral effects of five dosage levels and a dose to be determined of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109; formerly SDZ 89-109) when…
- Trial name
- NCT00002268
- Testing
- Sevirumab
- Where
- 2 sites in United States
- Sponsor
- Sandoz
HIV Infections
Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix
Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of HIV (+) patients 1.
- Trial name
- HIVGP-BCG (NCT07182838)
- Testing
- HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair
HIV Infections
A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past
To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients.
- Trial name
- NCT00002320
- Testing
- Lamivudine, Zidovudine
- Where
- 22 sites in United States, Canada and 1 more
- Volunteers
- 320 people
- Sponsor
- Glaxo Wellcome
HIV Infections
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN…
- Trial name
- PALISADE (NCT06134362)
- Testing
- CAB LA
- Where
- 33 sites in Argentina, Botswana and 10 more
- Volunteers
- 2,996 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247)
This study will evaluate: (1) the effect of co-administration of single doses of calcium carbonate antacid and magnesium/aluminum hydroxide antacid on the steady-state plasma pharmacokinetic profile of raltegravir in human…
- Trial name
- NCT01622673
- Testing
- Raltegravir, TUMS® Ultra Strength, MINTOX® Maximum Strength
- Volunteers
- 27 people
- Sponsor
- Merck Sharp & Dohme LLC
Infections, Papillomavirus, Papillomavirus Vaccines
Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety and immunogenicity of Cervarix in HIV infected…
- Trial name
- NCT01031069
- Testing
- GSK Biologicals' HPV vaccine 580299, Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)
- Where
- 15 sites in Brazil, Estonia and 2 more
- Volunteers
- 873 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa
The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants.
- Trial name
- NCT00263666
- Testing
- Rotarix, Tritanrix-HB+Hib, Polio Sabin
- Where
- 6 sites in South Africa
- Volunteers
- 100 people
- Sponsor
- GlaxoSmithKline
Human Immunodeficiency Virus
Evaluation of Kaletra Therapy Over the Long-term
Long term observation of patients under lopinavir/ritonavir containing therapy
- Trial name
- NCT01083810
- Testing
- Lopinavir/Ritonavir (Kaletra)
- Where
- 90 sites in Germany
- Volunteers
- 284 people
- Sponsor
- Abbott
Infection, Human Immunodeficiency Virus
A Study of the Relative Bioavailability of BMS-626529 Administered as BMS-663068 From 150mg Low-dose Extended-release Tablets Compared to 600mg Reference Extended-release Tablets in Healthy Subjects
An oral dose in healthy subjects to determine the relative bioavailabilty of BMS-626529 administered as BMS-663068
- Trial name
- NCT02859259
- Testing
- BMS-663068 (1 tablet at 600 mg), BMS-663068 (4 tablets at 150 mg each tablet)
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV/AIDS
Risk of CV Events With EFV vs. EFV-free Regimens
The purpose of this study is to determine whether there is an increased risk of cardiovascular events (CV) with regimens containing efavirenz (EFV) versus other regimens in patients with HIV.
- Trial name
- NCT02426866
- Testing
- Efavirenz
- Volunteers
- 29,612 people
- Sponsor
- Bristol-Myers Squibb
Infection, Human Immunodeficiency Virus, HIV Infections
Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults
GSK2838232 is a novel HIV-1 maturation inhibitor (MI) that is being developed for the treatment of HIV-1 infection in combination with other antiretroviral therapy (ART).
- Trial name
- NCT03045861
- Testing
- GSK2838232, Cobicistat
- Where
- 14 sites in United States, Canada
- Volunteers
- 33 people
- Sponsor
- GlaxoSmithKline
HIV Infections, HIV Wasting Syndrome
A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
To evaluate the safety, antiviral and anti-TNF-alpha activity, and preliminary efficacy of thalidomide in reducing weight loss in patients with HIV wasting syndrome.
- Trial name
- NCT00002127
- Testing
- Thalidomide
- Where
- 13 sites in United States
- Volunteers
- 75 people
- Sponsor
- Celgene Corporation
HIV Infections
Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates
The purpose of the study is to study the effects of BMS-955176 on the single-dose PK parameters of probe substrates caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin
- Trial name
- NCT02578277
- Testing
- CYP and transporter probe substrates, BMS-955176, BMS-955176 plus CYP and transporter probe substrates
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Preexposure Prophylaxis
Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024)
The main purpose of the study is to evaluate the safety and tolerability of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who…
- Trial name
- Impower-024 (NCT04652700)
- Testing
- ISL, FTC/TDF, FTC/TAF
- Where
- 25 sites in United States, Brazil and 5 more
- Volunteers
- 494 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Human Immunodeficiency Virus Infection
Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)
The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when…
- Trial name
- PROGRESS (NCT00711009)
- Testing
- lopinavir/ritonavir (LPV/r), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), raltegravir (RAL)
- Where
- 37 sites in United States, Canada and 5 more
- Volunteers
- 206 people
- Sponsor
- Abbott
HIV Infections
Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)
This is a treatment use study to provide early access to MK0518 for the treatment of HIV-1 infection in patients who have limited or no treatment options due to virological failure, resistance, or intolerance to multiple…
- Trial name
- NCT00377065
- Testing
- raltegravir
- Sponsor
- Merck Sharp & Dohme LLC
EBV-induced Lymphomas, EBV-associated Malignancies
Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies
The purpose of this phase I/II trial is to study the side effects and best dose of biological therapy to treat patients at high-risk or with Epstein-Barr virus-associated lymphoma or lymphoproliferative disease.
- Conditions
- EBV-induced Lymphomas, EBV-associated Malignancies, Transplant Patients With EBV Viremia at High Risk of Developing a Recurrent EBV Lymphoma
- Trial name
- NCT00002663
- Testing
- Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Atara Biotherapeutics
HIV Infections
A Phase I Study of the Safety and Immunogenicity of Rgp 120/HIV-1IIIB Vaccine in HIV-1 Seropositive Adult Volunteers
To test the safety and immunogenicity of rgp 120/HIV-1IIIB vaccine in HIV-1 seropositive adult patients.
- Trial name
- NCT00001992
- Testing
- rgp120/HIV-1IIIB
- Where
- United States
- Sponsor
- Genentech, Inc.
Pharmacokinetics, Bioavailability
TMC278-TiDP38-C145: A Bioavailability Study in Healthy Adult Volunteers to Evaluate 3 Pediatric Formulations of TMC278 (a Solution, a Suspension, and Granules) Compared to an Adult Tablet Formulation
The purpose of this study is to evaluate how much and how fast a single, oral, daily 25 mg dose of TMC278 is absorbed into the body when administered as a solution, suspension, granules, or a tablet.
- Conditions
- Pharmacokinetics, Bioavailability, HIV-1
- Trial name
- NCT00812292
- Testing
- TMC278
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
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