Clinical trials: Infection, Human Immunodeficiency Virus I
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
Human Immunodeficiency Virus, Human Papillomavirus- 6, 11, 16, 18
A Phase I Study of Quadrivalent Human Papilloma Virus (HPV) (Types 6, 11, 16, 18) Recombinant Vaccine in HIV-Infected and HIV-Negative Pre-Adolescents, Adolescents, and Young Adults
Background: Human papilloma virus (HPV) is a common sexually transmitted disease. There are more than 100 different HPV types, and both males and females can get HPV infection.
- Conditions
- Human Immunodeficiency Virus, Human Papillomavirus- 6, 11, 16, 18, Adolescent, Papillomavirus Vaccines
- Trial name
- NCT00798265
- Testing
- Gardasil, Survey
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- National Cancer Institute (NCI)
Tuberculosis
A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-404 Administered as Different Amounts of Antigen and Adjuvant Combinations in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection
Phase I, randomized, double blinded, Placebo-controlled, immunogenicity and dose-range finding study of AERAS-404 in Bacille Calmette-Guerin (BCG) healthy adult male and sterile females.
- Trial name
- NCT02066428
- Testing
- AERAS-404
- Where
- Sweden
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Aeras
HIV Infections
Phase I/II Study of Curdlan Sulfate
To assess the safety and tolerance of curdlan sulfate, as well as its anti-HIV activity, in HIV-infected patients with CD4 T-lymphocytes less than 500 cells/mm3, using first single doses and then, after FDA review, daily doses…
- Trial name
- NCT00002100
- Testing
- Curdlan sulfate
- Where
- United States
- Sponsor
- AJI Pharma USA
Human Immunodeficiency Virus
Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults
This is a Phase I, randomized, double-blind, placebo-controlled clinical study to define the safety and immunogenicity resulting from a rapid dose-escalating vaccination schedule as compared to that of a co-administered…
- Trial name
- RV591 (NCT06205056)
- Testing
- Ad26.Mos4.HIV in CH505 TF chTrimer + ALFQ [Arm 1a], CH505 TF chTrimer + ALFQ [Arm 1a], Ad26.Mos4.HIV in CH505 TF chTrimer +ALFQ [Arm 2a]
- Where
- Uganda
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
HIV Infections, Pregnancy
A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women
To assess the pharmacokinetics, safety, and toxicity of intravenous and oral didanosine (ddI) administration in third trimester pregnant women who are HIV positive but are either intolerant or resistant to zidovudine (AZT).
- Trial name
- NCT00000839
- Testing
- Didanosine
- Where
- 13 sites in United States, Puerto Rico
- Volunteers
- 12 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Toxoplasmosis, Cerebral, HIV Infections
A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients With AIDS
To evaluate the effectiveness and toxicity of oral azithromycin and pyrimethamine as acute therapy for toxoplasmic encephalitis in AIDS patients.
- Trial name
- NCT00000966
- Testing
- Azithromycin, Pyrimethamine, Leucovorin calcium
- Where
- 11 sites in United States
- Volunteers
- 45 people
- Sponsor
- Pfizer
Circumcision Adult, HIV CDC Category B2
Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult MC Programs in Zimbabwe
The protocol, approved by the Medical Research Council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in Zimbabwe
- Conditions
- Circumcision Adult, HIV CDC Category B2, HIV Infections
- Trial name
- ZW-01 (NCT01956396)
- Testing
- PrePex™ device
- Where
- Zimbabwe
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Ministry of Health and Child Welfare, Zimbabwe
HIV Infections
Phase I Safety and Immunogenicity Preventative Vaccine Trial Based on Recombinant Tat Protein
This Phase I study is directed at evaluating the safety profile (as a primary end-point) and the immunogenicity (as a secondary end-point) of the recombinant HIV-1 Tat vaccine in healthy, immunologically competent adult subjects…
- Trial name
- ISSP-001 (NCT00529698)
- Testing
- Biologically active recombinant Tat protein
- Where
- 4 sites in Italy
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Istituto Superiore di Sanità
Tuberculosis
A Study to Evaluate Safety and Immunogenicity of AERAS-402 Administered in HIV-negative, BCG-vaccinated, QFT (+) and (-) Adults Without Evidence of TB
The available live tuberculosis vaccine Bacillus Calmette-Guérin (BCG) provides incomplete protection against pulmonary tuberculosis.
- Trial name
- C-012-402 (NCT02430506)
- Testing
- AERAS-402
- Where
- Kenya
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Aeras
HIV Infections
Safety of and Immune Response to a DNA HIV Vaccine (pGA2/JS7) Boosted With a Modified Vaccinia HIV Vaccine (MVA/HIV62) in Healthy Adults
The purpose of this study is to determine the safety of and immune response to a DNA HIV vaccine, pGA2/JS7, followed by a modified vaccinia (smallpox) HIV vaccine, MVA/HIV62, in HIV uninfected adults.
- Trial name
- NCT00301184
- Testing
- pGA2/JS7 DNA, Modified vaccinia Ankara/HIV62
- Where
- 6 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Comparison of Dendritic Cell-Based Therapeutic Vaccine Strategies for HIV Functional Cure
This study will be done in people living with HIV to see if an investigational vaccine made from a person's own white blood cells is safe and tolerated.
- Trial name
- DC-HIV04 (NCT03758625)
- Testing
- a1DC + inactivated whole autologous HIV, a1DC + conserved HIV peptides, a1DC + no antigen
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Sharon Riddler
HIV-1 Infection
Study to Evaluate Effects of Vorinostat and HXTC on Persistent HIV-1 Infection in HIV-Infected Subjects Started on Antiretroviral Therapy (ART)
This is a phase I, single-site, study to evaluate the effects of VOR and HIV-1 Antigen Expanded Specific T Cell Therapy (HXTC) on persistent HIV-1 Infection in HIV-infected individuals suppressed on ART.
- Trial name
- XTRA (NCT03212989)
- Testing
- Vorinostat, HXTC
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of North Carolina, Chapel Hill
Lymphoma, Nonneoplastic Condition
Study of Blood and Tissue Samples From Patients With Aggressive Non-Hodgkin B-Cell Lymphoma or Hodgkin Lymphoma
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
- Trial name
- NCT00981097
- Testing
- polymerase chain reaction, laboratory biomarker analysis
- Where
- 16 sites in United States
- Volunteers
- 52 people
- Sponsor
- AIDS Malignancy Consortium
HIV Infections
A Study to Test the Safety, Tolerance, and Metabolism of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy in Newborn Infants Born to HIV-1 Infected Women
The purpose of this study is to determine the safety, tolerance, and metabolism of single-dose and multiple-dose abacavir (ABC) in HIV-exposed infants receiving standard postnatal treatment with zidovudine (ZDV).
- Trial name
- NCT00000864
- Testing
- Abacavir sulfate, Zidovudine
- Where
- 13 sites in United States, Puerto Rico
- Volunteers
- 60 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
Safety and Efficacy Study of Etanercept (Enbrel) on the Response Rate of HIV-infected Subjects
The purpose of conducting this already-FDA approved Phase I clinical trial is to evaluate the safety and efficacy of etanercept (Enbrel) on the response rate in HIV-infected subjects who have failed to respond to conventional…
- Trial name
- NCT00091741
- Testing
- Etanercept (Enbrel)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Georgetown University
Tuberculosis, HIV
Safety, Tolerability, and Effect of TMC207 and Efavirenz in Healthy Volunteers
Common treatments for tuberculosis (TB) can interfere with certain antiretroviral (ARV) medications used to treat HIV. People whose immune systems are weakened by HIV infection are susceptible to TB, so it is important to find…
- Trial name
- NCT00992069
- Testing
- Efavirenz (EFV), TMC207
- Where
- 5 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
Microbiota Restoration Therapy in HIV With Repeated Low-Dose Interventions
Altered interplay between gut mucosa and dysbiotic bacteria during HIV infection seems to contribute to chronic immune dysfunction.
- Trial name
- REFRESH (NCT03008941)
- Testing
- FMT
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
HIV I Infection
Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy
The purpose of this study is to evaluate whether a single dose of Nivolumab in people living with HIV can reduce the latent reservoir.
- Trial name
- NIVO-LD (NCT05187429)
- Testing
- Nivolumab 10 MG/ML [Opdivo], Saline
- Where
- 2 sites in Australia, Singapore
- Volunteers
- 42 people
- Sponsor
- University of Melbourne
HIV Infections
Candidate HIV Vaccine
This study will evaluate whether an experimental vaccine intended to prevent HIV infection is safe and whether it causes any side effects.
- Trial name
- NCT00089531
- Testing
- VRC-HIVDNA016-00-VP
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)