Clinical trials: Immunodeficiencies
Infection, Human Immunodeficiency Virus
Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine
This study aims to compare the bioequivalence of two experimental fixed dose combination (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in healthy adult subjects.
- Trial name
- NCT03078556
- Testing
- Dolutegravir, Lamivudine, Dolutegravir + Lamivudine FDC Formulation 1
- Where
- United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections, Hepatitis B
Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection
This study will evaluate HIV-HBV infected individuals who have evidence of HBV replication in the blood after taking 48 weeks of more of the HBV active medication tenofovir in combination with emtricitabine or lamivudine.
- Trial name
- NCT00662545
- Testing
- Entecavir with continued standard of care antiretroviral therapy, continued standard of care with tenofovir in addition to emtricitabine or lamivudine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of California, San Francisco
Ataxia Telangiectasia
Evaluate the Neurological Effects of EryDex on Subjects With A-T
This is an international, multi-center, randomized, prospective, double-blind, placebo-controlled, Phase 3 study, designed to assess the effect of EryDex (dexamethasone sodium phosphate [DSP] in autologous erythrocytes)…
- Trial name
- NEAT (NCT06193200)
- Testing
- Dexamethasone sodium phosphate
- Where
- 19 sites in United States, Denmark and 7 more
- Volunteers
- 105 people
- Sponsor
- Quince Therapeutics S.p.A.
Human Immunodeficiency Virus
Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women
HIV Open-label Prevention Extension (HOPE).
- Trial name
- NCT02858037
- Testing
- Dapivirine Vaginal Ring
- Where
- 17 sites in Malawi, South Africa and 2 more
- Volunteers
- 1,456 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Bone Marrow Failure Syndrome, Thalassemia
Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation
In this study, the investigators test 2 dose levels of thiotepa (5 mg/kg and 10 mg/kg) added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG) to determine the minimum…
- Conditions
- Bone Marrow Failure Syndrome, Thalassemia, Sickle Cell Disease, Diamond Blackfan Anemia
- Trial name
- NCT03513328
- Testing
- Thiotepa--single daily dose, Thiotepa--escalated dose
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Florida
HIV-1 Infection
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
The primary objectives of this study are: Part A: To evaluate the short-term antiviral activity of lenacapavir (formerly GS-6207) with respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day…
- Trial name
- NCT03739866
- Testing
- Lenacapavir, B/F/TAF, TAF
- Where
- 12 sites in United States
- Volunteers
- 53 people
- Sponsor
- Gilead Sciences
HIV Infections, H1N1 Influenza Virus
Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth
Children and people infected with HIV are particularly susceptible to influenza infections. This study testED the safety and effectiveness of a vaccine for the new H1N1 influenza virus in children and youth infected with HIV.
- Trial name
- NCT00992836
- Testing
- Influenza A (H1N1) 2009 monovalent vaccine
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 155 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
BRAVO: Background Regimen of Raltegravir on Virologic Outcome
This is a retrospective chart review of participants in raltegravir expanded access program and will compare virologic response in regimens not containing a protease inhibitor in the antiretroviral background regimen to regimens…
- Trial name
- BRAVO (NCT00751530)
- Testing
- raltegravir
- Where
- 15 sites in United States
- Volunteers
- 442 people
- Sponsor
- Community Research Initiative of New England
HIV Infections
"The Once A Day Protease Inhibitor Regimens"
Atazanavir (ATV) and fosamprenavir (fAPV) are new protease inhibitors that can be administered once-a-day and boosted with ritonavir (r).
- Trial name
- NCT00242216
- Testing
- ritonavir-boosted atazanavir, ritonavir-boosted fosamprenavir
- Where
- United States
- Volunteers
- 76 people
- Sponsor
- The University of Texas Health Science Center, Houston
HIV Infections, Heart Disease
Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease
Several studies have shown that there is an increased risk of heart disease in people with HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid) on improving endothelial function and…
- Trial name
- NCT01001767
- Testing
- Lovaza
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University Hospitals Cleveland Medical Center
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
HIV Infections
(mo)BETTA Trial in Transwomen for Optimization of ART
The purpose of this study is to determine the safety and tolerability of a new HIV medication, bictegravir plus emtricitabine plus tenofovir alafenamide (B/FTC/TAF, 3 HIV medications combined into one pill) in HIV-infected…
- Trial name
- (mo)BETTA (NCT03348163)
- Testing
- B/FTC/TAF, Current ART
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- The University of Texas Health Science Center, Houston
HIV Infections, Hepatitis C
Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)
Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and…
- Conditions
- HIV Infections, Hepatitis C, Liver Disease
- Trial name
- NCT00078403
- Testing
- Peginterferon alfa-2a, Ribavirin
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 333 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Comparison of Liquid Kaletra and Low Dose Kaletra Tablets
Kaletra (a combination drug with lopinavir and ritonavir) is one of a few effective medications that are approved and available for young children who are HIV+.
- Trial name
- NCT00762320
- Testing
- Low dose Kaletra tablets
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Phoenix Children's Hospital
HIV
Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)
This study will evaluate the safety and tolerability of the combination of truvada and raltegravir given for 28 days for the prevention of HIV infection.
- Trial name
- NCT01214759
- Testing
- Truvada, Raltegravir
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- The University of Texas Health Science Center, Houston
HIV Infections
Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women
A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) are oral…
- Trial name
- NCT00705679
- Testing
- Emtricitabine/tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate, Tenofovir 1% vaginal gel
- Where
- 15 sites in South Africa, Uganda and 1 more
- Volunteers
- 5,029 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Lung Cancer, Lymphoma
Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies
RATIONALE: Collecting and studying tissue samples 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
- NCT01567722
- Testing
- DNA analysis, RNA analysis, gene expression analysis
- Where
- 14 sites in United States
- Volunteers
- 114 people
- Sponsor
- AIDS Malignancy Consortium
Hiv
Time to Protection and Adherence Requirements of Raltegravir With or Without Lamivudine in Protection From HIV Infection
This study evaluates whether a 7-day course of Raltegravir 400mg bd or Raltegravir 400mg/lamivudine 150mg bd can prevent HIV from infecting genital tissue and will relate the level of drug in the blood to the level of drug in…
- Trial name
- R-PrEP (NCT03205566)
- Testing
- Raltegravir 400Mg Tab, Lamivudine 150Mg Tablet
- Where
- United Kingdom
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Hiv
Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the…
- Trial name
- PrEP-PP (NCT03826199)
- Testing
- TDF-FTC, Counselling on PrEP in antenatal and postnatal care
- Where
- South Africa
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Non Malignant Disorders, Immunodeficiencies
Reduced Intensity Conditioning for Umbilical Cord Blood Transplant in Pediatric Patients With Non-Malignant Disorders
The primary objective is to determine the feasibility of attaining acceptable rates of donor cell engraftment (>25% donor chimerism at 180 days) following reduced intensity conditioning (RIC) regimens in pediatric patients < 21…
- Conditions
- Non Malignant Disorders, Immunodeficiencies, Congenital Marrow Failures, Hemoglobinopathies
- Trial name
- NCT00744692
- Testing
- Unrelated Umbilical Cord Blood Transplant, Reduced Intensity Conditioning
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Duke University
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