Clinical trials: Immunologic Deficiency Syndrome
Acquired Immunodeficiency Syndrome
Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg.
Objective: To evaluate the relative bioavailability of a new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare this formulation with the branded formulation (R)…
- Trial name
- NCT02583464
- Testing
- Tenofovir disoproxil fumarate and emtricitabine
- Where
- Argentina
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Laboratorio Elea Phoenix S.A.
HIV Infections
Observational Study on Predictors of Response to Invirase (Saquinavir) Treatment in Treatment-naïve Patients With HIV Infection
This prospective observational study will evaluate predictors of response to Invirase (saquinavir) treatment in treatment-naïve patients with HIV infection. Data will be collected during 48 weeks of treatment.
- Trial name
- NCT01297127
- Where
- 8 sites in Poland
- Volunteers
- 151 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
A Study of 1592U89 in HIV-Infected Adults
The purpose of this study is to see if it is safe and effective to give 1592U89 to HIV-positive adults. This study also examines the influence previous anti-HIV treatment has on the effectiveness of 1592U89.
- Trial name
- NCT00002200
- Testing
- Abacavir sulfate
- Where
- United States
- Sponsor
- Glaxo Wellcome
HIV-1 Infection
MK-8583 Single Dose Study in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8583-002)
This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-retroviral therapy (ART) activity of the tenofovir prodrug, MK-8583 monotherapy in ART-naïve, HIV-1 infected participants.
- Trial name
- NCT03552536
- Testing
- MK-8583
- Where
- Germany
- Volunteers
- 5 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Volunteers
Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male and/or female subjects, to estimate the effect of steady state lersivirine on the steady state pharmacokinetics of abacavir/lamivudine.
- Trial name
- NCT01220232
- Testing
- Abacavir/Lamivudine, Lersivirine
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Pfizer
HIV Infections
Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
To define the pharmacokinetic characteristics of Nystatin LF IV (intravenous) in human subjects with AIDS-related complex (ARC) after administration of a single IV dose at each of 4 dose levels.
- Trial name
- NCT00001998
- Testing
- Nystatin
- Where
- United States
- Sponsor
- Argus Pharmaceuticals
Human Immunodeficiency Virus; HIV
An Immunologic Study of Treatment-Naive HIV Patients Starting a Darunavir/Ritonavir- or Efavirenz-Based HAART
The purpose of this study is to study the kinetics (study of the rate of change) of immune recovery quality and function in stored plasma blood samples of treatment-naive (not previously treated with antiretroviral drugs)…
- Trial name
- NCT01541085
- Testing
- Darunavir/Ritonavir (DRV/r), Efavirenz (EFV)
- Volunteers
- 33 people
- Sponsor
- Janssen-Cilag S.p.A.
Cytomegalovirus Retinitis, HIV Infections
Valganciclovir in Patients With CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
The purpose of this study is to make valganciclovir available, before it is approved for marketing, to HIV-infected patients who have cytomegalovirus (CMV) retinitis (eye infection) and cannot take drugs by injection.
- Trial name
- NCT00017784
- Testing
- Valganciclovir
- Where
- 9 sites in United States, Puerto Rico
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
HIV Infections, HIV-1
TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants
The purpose of this study is to provide etravirine (ETR) through this trial until participants can be switched to locally available ETR-based treatment regimens (that is, commercially available and reimbursed, or accessible…
- Trial name
- NCT00980538
- Testing
- Etravirine
- Where
- 29 sites in United States, Argentina and 9 more
- Volunteers
- 180 people
- Sponsor
- Janssen Sciences Ireland UC
Primary Immunodeficiency Disorders (PIDs)
Leniolisib for Immune Dysregulation in PIDs
This study is an exploratory, non-randomized, open-label, within-patient dose escalation study. The primary objective is to assess safety and tolerability of leniolisib.
- Trial name
- NCT06549114
- Testing
- Leniolisib
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Pharming Technologies B.V.
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
HIV Infections
Combination Treatment Using Capravirine (AG1549), Nelfinavir, and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Patients Who Failed Initial Combination Therapy
The purpose of this study is to look at the effectiveness of an anti-HIV drug combination that adds capravirine in patients who have failed their first drug combination treatment.
- Trial name
- NCT00004985
- Testing
- Capravirine, Nelfinavir mesylate
- Where
- 34 sites in United States, Puerto Rico
- Volunteers
- 75 people
- Sponsor
- Agouron Pharmaceuticals
HIV Infections
A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen
The purpose of this study is to evaluate the safety and efficacy of a novel nucleoside sparing regimen containing atazanavir, ritonavir and efavirenz, using two different doses of atazanavir.
- Trial name
- NCT00135343
- Testing
- Atazanvir/ritonavir + efavirenz
- Where
- 15 sites in United States
- Volunteers
- 60 people
- Sponsor
- Bristol-Myers Squibb
Hereditary Angioedema
Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II
KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.
- Trial name
- KONFIDENT-KID (NCT06467084)
- Testing
- KVD900 150 mg, KVD900 300 mg, KVD900 600 mg
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 36 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
HIV Infections
A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.
To compare the antiviral effect of stavudine ( d4T ) versus placebo in patients with evidence of recent HIV infection. Also, to compare the immunologic effects and effects on quality of life of d4T in these patients.
- Trial name
- NCT00002349
- Testing
- Stavudine
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Bristol-Myers Squibb
Infection, Human Immunodeficiency Virus
Efficacy and Safety of ACC017 Tablets Compared With Dolutegravir Sodium Tablets in Treatment-Naïve Adults With Human Immunodeficiency Virus Type 1 (HIV-1)
This study employs a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group, non-inferiority design.
- Trial name
- NCT07711223
- Testing
- ACC017+FTC/TAF, DTG+FTC/TAF
- Where
- China
- Volunteers
- 660 people
- Sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd.
Hereditary Angioedema, HAE
Open-label, Long-term Safety Study of Avoralstat in Subjects With Hereditary Angioedema
This is an open-label study designed to evaluate the long-term safety of prophylactic avoralstat (500 mg three times daily) when given to approximately 150 patients with hereditary angioedema (HAE) for a duration of up to 72…
- Trial name
- OPuS-4 (NCT02670720)
- Testing
- avoralstat
- Where
- 3 sites in Belgium, France
- Volunteers
- 6 people
- Sponsor
- BioCryst Pharmaceuticals
Hepatitis C
A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)
The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve…
- Trial name
- NCT01467479
- Testing
- Telaprevir, Ribavirin, Pegylated Interferon Alfa-2a
- Where
- 59 sites in United States, Canada and 3 more
- Volunteers
- 185 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Infection, Human Immunodeficiency Virus
A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)
This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male and female subjects. There is no formal hypothesis, however, it is expected that the coadministration of BMS-663068 with darunavir…
- Trial name
- NCT02277600
- Testing
- BMS-663068, Darunavir, Cobicistat
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus
A Study to Evaluate the Effect of High Fat Meal on Cabotegravir
Cabotegravir is being developed for the treatment of human immunodeficiency virus (HIV) 1 infection. Specifically, it is being developed as a component of a 2-drug maintenance regimen (post-induction of viral suppression) that…
- Trial name
- NCT02799264
- Testing
- Cabotegravir 30 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare