Clinical trials: Immunologic Deficiency Syndrome
HIV Infection
TMC125-C223: TMC125 in HIV-1 Infected Subjects
The purpose of this study is to investigate the ability of TMC125, a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), to lower the amount of virus in your blood when administered twice daily for 48 weeks.
- Trial name
- NCT00081978
- Testing
- TMC125
- Volunteers
- 211 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infections
Pharmacodynamics, Safety and Pharmacokinetics of BMS-663068, an HIV Attachment Inhibitor, in HIV-1
Research Hypothesis: Administration of BMS-663068, a prodrug for HIV attachment inhibitor BMS-626529, will result in a mean decrease of at least 1 log10 in HIV RNA at Day 9 following 8 days of therapy in at least one dosing…
- Trial name
- NCT01009814
- Testing
- BMS-663068, Ritonavir
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- ViiV Healthcare
Hepatitis C, HIV
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics…
- Trial name
- NCT01565889
- Testing
- SOF, EFV/FTC/TDF, EFV
- Where
- Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences
Healthy
Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination
The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of Emtricitabine (FTC) and Tenofovir alafenamide (TAF) when administered as a fixed-dose combination (FDC) with darunavir (DRV) and…
- Trial name
- NCT02475135
- Testing
- Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC, Elvitegravir /Cobicistat/Emtricitabine/Tenofovir alafenamide FDC, Darunavir
- Where
- Belgium
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Janssen Sciences Ireland UC
HIV Infections, Health Volunteers
A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults
The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological sequelae associated with exposure to ABX464 and to explore selected immunological endpoints, compartmental pharmacokinetics, and…
- Trial name
- NCT02990325
- Testing
- ABX464 150mg, ABX464 50mg
- Where
- Spain
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Abivax S.A.
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 Infection, Cardiovascular Disease
HIV Treatment and CVD Events
Cardiovascular disease (CVD) has been associated with HIV infection. However, it is uncertain whether increased CVD rates are associated with HIV-related factors (e.g., HIV-infection or highly active antiretroviral therapy…
- Conditions
- HIV Infection, Cardiovascular Disease, Infection, Human Immunodeficiency Virus, Acute Myocardial Infarction
- Trial name
- NCT01054638
- Testing
- HAART Treatment
- Sponsor
- ViiV Healthcare
Acquired Immunodeficiency Syndrome, HIV Infections
Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents
The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single-tablet regimen…
- Trial name
- NCT01721109
- Testing
- EVG/COBI/FTC/TDF
- Where
- 18 sites in United States, South Africa and 1 more
- Volunteers
- 50 people
- Sponsor
- Gilead Sciences
HIV Infections
A Study of Indinavir Taken With or Without DMP 266
The purpose of this study is to see if it is safe and effective to add DMP 266 to an anti-HIV treatment program of indinavir and nucleoside reverse transcriptase inhibitors (NRTIs).
- Trial name
- NCT00002393
- Testing
- Indinavir sulfate, Efavirenz
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 300 people
- Sponsor
- Dupont Merck
HIV Infections
Trial of SAVVY Vaginal Gel and HIV in Nigeria
Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of…
- Trial name
- NCT00130078
- Testing
- 1.0% C31G SAVVY vaginal gel
- Where
- 2 sites in Nigeria
- Volunteers
- 2,142 people, healthy volunteers welcome
- Sponsor
- Biosyn
Human Immunodeficiency Viruses
Evaluation of Diagnostic HIV Ag/Ab Combo Assay
To test blood specimens using a new investigational test that detects antigen and antibody to human immunodeficiency virus (HIV).
- Trial name
- NCT00933933
- Testing
- ARCHITECT HIV Ag/Ab Combo
- Where
- 13 sites in United States
- Volunteers
- 635 people, healthy volunteers welcome
- Sponsor
- Abbott Diagnostics Division
Hereditary Angioedema
Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema
The purpose of the Expanded Access Program is to provide pre-approval access of donidalorsen to eligible patients with Hereditary Angioedema (HAE) who complete the ISIS 721744-CS3 clinical trial.
- Trial name
- NCT06415448
- Testing
- Donidalorsen
- Sponsor
- Ionis Pharmaceuticals, Inc.
HIV Infections
A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (< 400 copies/ml) at week 24 of study therapy.
- Trial name
- NCT00002378
- Testing
- Ritonavir, Nelfinavir mesylate, Saquinavir
- Where
- 102 sites in United States, Germany and 4 more
- Volunteers
- 825 people
- Sponsor
- Hoffmann-La Roche
Hereditary Angioedema
A Relative Bioavailability Study of Two Formulations of BCX7353
This is an open-label, randomized study to investigate the relative bioavailability of two formulations of BCX7353 and to determine if there is a food effect
- Trial name
- NCT03202784
- Testing
- BCX7353
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Infection, Human Immunodeficiency Virus, HIV Infections
Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)
The purpose of this study is to evaluate the long-term persistence of binding antibody responses against V1V2 and gp120 in subjects who were vaccinated with the envelope glycoprotein 120 (gp120)-negative factor (Nef)Tat/ Adjuvant…
- Trial name
- NCT03368053
- Testing
- Blood sampling
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections
Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-naive Participants
Elvucitabine, a novel nucleoside analog, is being studied as a treatment for participants with human immunodeficiency virus (HIV)-1.
- Trial name
- NCT00350272
- Testing
- Elvucitabine, Lamivudine, Tenofovir
- Where
- 26 sites in United States, Puerto Rico
- Volunteers
- 76 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
HIV Infection
Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients
The investigation will be conducted for the purpose of determining the condition of occurrence of Adverse Events under the actual post-marketing use of Zithromac 600mg Tablet, verifying the therapeutic effects, detecting unknown…
- Trial name
- NCT01227395
- Testing
- Azithromycin
- Volunteers
- 476 people
- Sponsor
- Pfizer
HIV Infections
A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients
The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.
- Trial name
- NCT00002195
- Testing
- Amprenavir, Lamivudine, Zidovudine
- Where
- 9 sites in United States
- Volunteers
- 290 people
- Sponsor
- Glaxo Wellcome
HIV Infections, Acquired Immunodeficiency Syndrome
TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients
The purpose of this study is to determine the pharmacokinetics (how the body absorbs, distributes, metabolizes and eliminates a drug) (PK) of ETR when given with ATV/rtv and 1 NRTI in treatment experienced HIV-1 infected…
- Trial name
- NCT00896051
- Testing
- Atazanavir (ATV) 300 mg, Atazanavir (ATV) 400 mg, Ritonavir (rtv) 100 mg
- Where
- 18 sites in United States, Argentina and 3 more
- Volunteers
- 50 people
- Sponsor
- Janssen R&D Ireland
Humoral Immune Response
Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16
This study is part of the BIVIGAM® post marketing requirement (PMR). It is being conducted in subjects aged 2-16 with primary immune deficiency disorders associated with defects in humoral immunity to generate additional data on…
- Trial name
- NCT03164967
- Testing
- Bivigam
- Where
- 8 sites in United States
- Volunteers
- 16 people
- Sponsor
- ADMA Biologics, Inc.
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