Clinical trials: Infection, Human Immunodeficiency Virus I
HIV Infections
A Phase I Trial of APL 400-003 Vaccine: Safety and Immune Response Evaluations of Multiple Injections at Escalating Doses in Asymptomatic HIV-Infected Patients
To evaluate safety and immune response in HIV-infected patients treated with multiple injections of APL 400-003 vaccine. PER 2/27/96 AMENDMENT: To evaluate the safety of the vaccine when administered via the Biojector 2000…
- Trial name
- NCT00002350
- Testing
- APL 400-003
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Apollon
Infection, Human Immunodeficiency Virus
Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet
This is an open-label, randomized, crossover study in healthy adult subjects with 5 treatment groups over 5 dosing periods. This study will evaluate pharmacokinetic parameters and relative bioavailability of a dispersible…
- Trial name
- NCT02893488
- Testing
- DTG/ABC/3TC FDC DISPERSIBLE TABLET, EPZICOM (ABC/3TC), TIVICAY (DTG)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus I
A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96.
- Trial name
- SPRING-2 (NCT01227824)
- Testing
- GSK1349572 (dolutegravir), raltegravir, ABC/3TC
- Where
- 101 sites in United States, Australia and 7 more
- Volunteers
- 828 people
- Sponsor
- ViiV Healthcare
HIV Infections
Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients
The purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the growth of HIV in patients infected with the virus.
- Trial name
- NCT00038220
- Testing
- Lopinavir/ritonavir, Efavirenz, Lamivudine
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Abbott
HIV Infections
Safety and Immunogenicity of HIVAX in HIV-1 Infected Subjects
This study is to test a therapeutic HIV-1 vaccine (HIVAX™) in HIV-1 infected subjects. The safety and immune responses will be studied in vaccine recipients.
- Trial name
- GCHT01 (NCT01428596)
- Testing
- HIVAX, saline solution
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- GeneCure Biotechnologies
HIV Infections
Safety of an HIV Vaccine (AVX101) in HIV Uninfected Volunteers in the United States and South Africa
The purpose of this study is to see if different doses of an experimental HIV vaccine are safe and to study how the immune system responds to the vaccine. The vaccine will be tested in healthy, HIV uninfected volunteers.
- Trial name
- NCT00063778
- Testing
- AVX101
- Where
- 7 sites in United States, South Africa
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AlphaVax, Inc.
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 Infections
T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents
This study will evaluate T-20 in children.
- Trial name
- NCT00022763
- Testing
- Enfuvirtide
- Where
- 7 sites in United States
- Volunteers
- 52 people
- Sponsor
- Hoffmann-La Roche
Healthy Subjects, Infection, Human Immunodeficiency Virus
DDI Study of Etravirine and GSK1265744
The primary objective of this study is to compare steady-state plasma PK, safety and tolerability of GSK1265744 with and without etravirine
- Trial name
- NCT00920296
- Testing
- GSK1265744
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections
A Study of 141W94 in Combination With Other Anti-HIV Drugs
To determine the steady-state pharmacokinetics of 141W94 in combination with saquinavir, indinavir and nelfinavir after multiple oral dosing.
- Trial name
- NCT00002372
- Testing
- Indinavir sulfate, Amprenavir, Nelfinavir mesylate
- Where
- 3 sites in United States
- Volunteers
- 48 people
- Sponsor
- Glaxo Wellcome
Infection, Human Immunodeficiency Virus
A Study to Evaluate the Effects of Calcium Carbonate and Ferrous Fumarate on Pharmacokinetics of Dolutegravir in Healthy Adult Subjects
Human immune virus (HIV) infected subjects may take mineral supplements in combination with their antiretroviral medications. Calcium and Iron supplementations are commonly used and both of these have the potential to interact…
- Trial name
- NCT01762995
- Testing
- Dolutegravir 50 mg, Calcium Carbonate 1200 mg, Ferrous Fumarate 324 mg
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients
To determine the MTD and dose-limiting toxicities of recombinant interleukin-2 (aldesleukin; Proleukin) administered subcutaneously in HIV-seropositive patients.
- Trial name
- NCT00002107
- Testing
- Aldesleukin
- Where
- United States
- Sponsor
- Chiron Corporation
HIV Infections, Cytopenias
A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients With AIDS or AIDS-Related Complex
To evaluate the safety, tolerance and biological activity of filgrastim (granulocyte colony-stimulating factor; G-CSF) given by daily subcutaneous (SC) injection prior to and concomitantly with erythropoietin (EPO) and zidovudine…
- Trial name
- NCT00002281
- Testing
- Filgrastim, Epoetin alfa, Zidovudine
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Amgen
HIV Infections
Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
This protocol represents the first in human study of TUTI-16, and is being conducted to establish the safety and human immunogenicity (anti-HIV-1 Tat titers) of subcutaneously administered TUTI-16.
- Trial name
- THYMON-08001 (NCT00848211)
- Testing
- TUTI-16 (0.03mg), TUTI-16 (0.1mg), TUTI-16 (0.6mg)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Thymon, LLC
HIV Infections
Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection
Apricitabine is a new NRTI which is active against drug-resistant HIV. NRTIs are often included as part of patients' treatment, but many HIV-infected patients develop resistance to commonly used NRTIs such as lamivudine (3TC) and…
- Trial name
- NCT00612898
- Testing
- apricitabine, lamivudine
- Where
- 100 sites in United States, Australia and 9 more
- Volunteers
- 239 people
- Sponsor
- Avexa
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
Bioavailability Study of 10 Milligram (mg) and 5 mg Tablets Versus Conventional Tablets of Dolutegravir
The aim of this cross-over study is to compare the relative bioavailability and pharmacokinetic parameters of both 10 mg conventional tablets and 5 mg dispersible tablets of dolutegravir (DTG) with that of 25 mg or 50 mg…
- Trial name
- NCT03095638
- Testing
- Conventional dolutegravir 10 mg tablet, Conventional dolutegravir 50 mg tablet, Dispersible dolutegravir 5 mg tablet
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Pneumonia, Pneumocystis Carinii, HIV Infections
Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis Carinii Pneumonia
To evaluate the safety of the combination of trimetrexate glucuronate (TMTX) and dapsone with leucovorin protection versus trimethoprim/sulfamethoxazole (TMP/SMX) in patients with AIDS and moderately severe Pneumocystis carinii…
- Trial name
- NCT00002120
- Testing
- Trimetrexate glucuronate, Trimethoprim, Sulfamethoxazole
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- U.S. Bioscience
HIV Infections
The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children
To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in combination with nelfinavir and nucleoside…
- Trial name
- NCT00002380
- Testing
- Nelfinavir mesylate, Saquinavir
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Hoffmann-La Roche
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