Clinical trials: Antivirals/HIV
HIV-1
Phase 1, Open-label, Single Dose Study to Examine Safety, Tolerability, Pharmacokinetics and Virologic Impact of VRC01LS or VRC07-523LS in HIV-infected Viremic Adults
Background: The human body uses antibodies as one way to help fight infection. VRC01LS and VRC07-523LS are antibodies directed against the HIV virus. Researchers want to see if they are safe and well tolerated.
- Trial name
- NCT02840474
- Testing
- VRC-HIVMAB080-00-AB, VRC-HIVMAB075-00-AB
- Where
- 7 sites in United States, Puerto Rico
- Volunteers
- 16 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Study of BMY-27857 in Patients With AIDS or AIDS Related Complex
To evaluate the safety, minimum effective dose (MED), pharmacokinetics and efficacy of orally administered 2',3'-dideoxy-2',3'-didehydrothymidine (d4T) in patients with AIDS or AIDS related complex (ARC).
- Trial name
- NCT00000988
- Testing
- Stavudine
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cytomegalovirus Retinitis, HIV Infections
Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients With AIDS Who Have CMV Retinitis
To compare cidofovir with a commonly used treatment regimen, ganciclovir given by mouth (oral) and through an eye device (intraocular) , in order to determine the safety and effectiveness of cidofovir in preventing vision loss in…
- Trial name
- NCT00000894
- Testing
- Cidofovir, Probenecid, Ganciclovir
- Where
- 12 sites in United States
- Volunteers
- 300 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
The purpose of this study is to see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.
- Trial name
- NCT00002219
- Testing
- Nelfinavir mesylate, Levocarnitine, Adefovir dipivoxil
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Gilead Sciences
Infection, Human Immunodeficiency Virus
A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.
The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an…
- Trial name
- VIKING-3 (NCT01328041)
- Testing
- dolutegravir
- Where
- 89 sites in United States, Belgium and 5 more
- Volunteers
- 183 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naïve HIV-1 Infected Patients
This open-label study will evaluate the safety, pharmacokinetics and antiviral activity of a modified Invirase (saquinavir)/ritonavir regimen in treatment-naïve HIV-1 infected patients.
- Trial name
- NCT01638650
- Testing
- Nucleoside Reverse Transcriptase Inhibitor (NRTIs), ritonavir, saquinavir [Invirase]
- Where
- United Kingdom
- Volunteers
- 23 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
A Randomized Phase II Efficacy, Activity and Safety Study of GLQ223 Alone and in Combination With Zidovudine in Symptomatic HIV-Infected Patients Without Prior Treatment With GLQ223 or Trichosanthin
This study involves GLQ223 administration to patients who have not previously been exposed to it, but who have received at least 9 months of zidovudine therapy.
- Trial name
- NCT00001989
- Testing
- Trichosanthin, Zidovudine
- Where
- 8 sites in United States
- Sponsor
- Genelabs Technologies
HIV Infections
A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA
To evaluate viral load in the blood stream of HIV-infected patients during a 28-day washout following cessation of long-term zidovudine ( AZT ) therapy.
- Trial name
- NCT00000840
- Where
- 8 sites in United States
- Volunteers
- 70 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy
To elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175, and to compare new treatment regimens with combinations of reverse…
- Trial name
- NCT00000831
- Testing
- Lamivudine, Stavudine, Zidovudine
- Where
- 40 sites in United States, Puerto Rico and 1 more
- Volunteers
- 280 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children
To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug.
- Trial name
- NCT00000851
- Testing
- Stavudine, Didanosine
- Where
- 35 sites in United States, Puerto Rico
- Volunteers
- 198 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
The Safety and Effectiveness of Bis-POM PMEA in HIV-Infected Patients
To study the safety, tolerance, single and multiple dose pharmacokinetics, and anti-HIV activity of bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a daily basis for 2 weeks to HIV-infected patients.
- Trial name
- NCT00002346
- Testing
- Adefovir dipivoxil
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Gilead Sciences
HIV Infections
A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection
This study assessed the safety and tolerability of enfuvirtide in participants with advanced HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens containing at least one product from each…
- Trial name
- NCT02582983
- Testing
- Enfuvirtide
- Where
- 5 sites in Thailand
- Volunteers
- 23 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
A Study of WF 10 IV Solution in Patients With Advanced HIV Disease
The purpose of this study is to see if it is safe and effective to give WF 10 (TCDO) to patients with advanced HIV disease who cannot or will not take zidovudine, didanosine, zalcitabine, or stavudine.
- Trial name
- NCT00002152
- Testing
- WF10
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Oxo Chemie GmbH
HIV Infections
Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 Patients
The purpose of this study is to provide long-term clinical safety and efficacy data for tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various degrees of renal impairment.
- Trial name
- NCT00106379
- Testing
- Truvada (tenofovir DF + emtricitabine), Emtriva (emtricitabine), Viread (tenofovir DF)
- Where
- 4 sites in United States
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences
HIV Infections
Safety, Tolerability, Drug Interactions, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive HIV-Infected Children Less Than 12 Years of Age
Development of tolerable and effective antiretroviral (ARV) drugs for use in children and adolescents remains a high priority. First-line therapy with non-nucleoside reverse transcriptase inhibitors (NNRTIs) has proven to be…
- Trial name
- NCT01975012
- Testing
- Rilpivirine
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Acquired Immune Deficiency Syndrome, AIDS
Pilot Study of a Raltegravir Based NRTI Sparing Regimen
This pilot study will provide data on the safety and efficacy of the combination of Raltegravir (RAL) 400mg BID + Atazanavir (ATV) 300 mg BID in Antiretroviral (ARV)-experienced subjects that have a suppressed HIV viral load on a…
- Conditions
- Acquired Immune Deficiency Syndrome, AIDS, Human Immunodeficiency Virus, HIV Infections
- Trial name
- NCT00814879
- Testing
- Raltegravir, Atazanavir, Standard treatment regimen
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Yale University
Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir…
- Trial name
- NCT01854775
- Testing
- E/C/F/TAF, E/C/F/TAF (Low Dose)
- Where
- 16 sites in United States, South Africa and 3 more
- Volunteers
- 129 people
- Sponsor
- Gilead Sciences
Herpes Simplex, HIV Infections
An Open, Multicenter Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies
To evaluate the safety and efficacy of intermittent intravenous (IV) foscarnet in the treatment of acyclovir-resistant herpes simplex virus (HSV) infections in AIDS patients and other immunocompromised patients.
- Trial name
- NCT00002272
- Testing
- Foscarnet sodium
- Where
- United States
- Sponsor
- Astra USA
Hepatitis C, Chronic, Mixed Cryoglobulinemia
Benefit of DAA Therapy in HCV Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia
Mixed cryoglobulinemia (MC) is common in patients with chronic hepatitis C virus (HCV) infection. Direct-acting antiviral (DAA) regimens are today very effective with sustained virological response rates (SVR12) above 90%.
- Trial name
- NCT03342261
- Testing
- DAA treatment
- Where
- France
- Volunteers
- 47 people
- Sponsor
- Hospices Civils de Lyon
HIV -1 Infection
Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life
The goal of this clinical trial is to learn if subcutaneous ePGT121v1-LS added to standard antiretroviral therapy (ART) is safe and helps improve HIV viral suppression in infants living with HIV in South Africa.
- Trial name
- ENABLE 1 (NCT07655128)
- Testing
- Broadly neutralizing antibody (bNAb) ePGT121v1-LS, Saline (0.9% NaCl)
- Volunteers
- 87 people
- Sponsor
- Hospital Universitario 12 de Octubre