Clinical trials: HIV I Infection
HIV Infections
Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children
Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find an appropriate dose of EFZ to use in combination with…
- Trial name
- NCT00000893
- Testing
- Nelfinavir mesylate, Efavirenz
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 103 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents
Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly.
- Trial name
- NCT00485264
- Testing
- Raltegravir poloxamer film coated tablet, Raltegravir chewable tablet, Raltegravir oral granules for suspension (20 mg/mL)
- Where
- 42 sites in United States, Argentina and 4 more
- Volunteers
- 153 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, Hepatitis C
The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections
To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with nucleoside analog therapy in HIV-positive patients with chronic hepatitis C.
- Trial name
- NCT00001035
- Testing
- Interferon alfa-2b, Zidovudine, Zalcitabine
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Study of Amprenavir in HIV-Infected Patients
The purpose of this study is to see if it is safe to give amprenavir (APV) to HIV-infected patients. This study also examines the effect APV has on the level of HIV in the blood.
- Trial name
- NCT00002405
- Testing
- Amprenavir
- Where
- United States
- Sponsor
- Glaxo Wellcome
HIV Infections
Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents
The purpose of this study was to find a safe and tolerable dose of the protease inhibitor (PI) atazanavir (ATV), with or without a low-dose boost of the PI ritonavir (RTV), when taken with other anti-HIV drugs in HIV infected…
- Trial name
- NCT00006604
- Testing
- ATV, Ritonavir
- Where
- 36 sites in United States, Puerto Rico and 1 more
- Volunteers
- 195 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1 Infection
Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)
This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily…
- Trial name
- NCT04233216
- Testing
- ISL, DOR, DOR/ISL
- Where
- 98 sites in United States, Australia and 16 more
- Volunteers
- 35 people
- Sponsor
- Merck Sharp & Dohme LLC
Infection, Human Immunodeficiency Virus
A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects
GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV.
- Trial name
- NCT00296504
- Testing
- fosamprenavir (GW433908), ritonavir
- Where
- 24 sites in United States, Brazil and 6 more
- Volunteers
- 753 people
- Sponsor
- ViiV Healthcare
HIV Infections
Drug Levels of Tablet and Liquid Forms of Lamivudine, Nevirapine, and Stavudine in HIV Infected Thai Children
The purpose of this study is to compare the blood levels, absorption, and breakdown of lamivudine (3TC), nevirapine (NVP), and stavudine (d4T) in a fixed-dose tablet to that of the individual liquid formulations of the same…
- Trial name
- NCT00312091
- Testing
- Lamivudine, nevirapine, and stavudine fixed-dose tablet, Lamivudine, Nevirapine
- Where
- 4 sites in Thailand
- Volunteers
- 44 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1-infection
Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings
IMPAACT 2016 was a multi-site, two-arm, individually randomized, controlled study to evaluate whether an Indigenous Leader Outreach Model (ILOM) of trauma-informed cognitive behavioral therapy (TI-CBT) delivered by Indigenous…
- Trial name
- NCT04024488
- Testing
- Youth TI-CBT Intervention Arm, Youth Discussion Control Arm, Caregiver TI-CBT Intervention Arm
- Where
- 8 sites in Botswana, Malawi and 2 more
- Volunteers
- 484 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
HIV/AIDS, HIV-1-infection
Simplifying Treatment and Monitoring for HIV (STREAM HIV)
This study seeks to determine the clinical efficacy and cost effectiveness of implementing an integrated model for HIV monitoring using point of care (POC) tenofovir (TFV) adherence testing and POC viral load (VL) monitoring in…
- Trial name
- NCT04341779
- Testing
- Point-of-care viral load testing and tenofovir adherence testing
- Where
- South Africa
- Volunteers
- 539 people
- Sponsor
- University of Washington
HIV Infections
A Phase I Concentration-Controlled Trial to Assess the Safety, Tolerance, Pharmacokinetics and Development of Decreased HIV-1 Susceptibility to the Combination of Atevirdine Mesylate (U-87201E), Zidovudine (AZT), and Didanosine (ddI)
Part I: To determine the pharmacokinetic dose for atevirdine mesylate ( U-87201E ) when used in combination with zidovudine ( AZT ). To determine the pharmacokinetic profiles of U-87201E and AZT over a 12-week period.
- Trial name
- NCT00000742
- Testing
- Atevirdine mesylate, Zidovudine, Didanosine
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
ART, HIV I Infection
Community Based Antiretroviral Therapy (CBART) Among Children on Chronic ART
A randomized, open label trial of two strategies for Virus Load Differentiated Care (VLDC) monitoring of virologic outcome in a rural community based treatment program in Zimbabwe.
- Trial name
- CBART (NCT03986099)
- Testing
- Monitoring virus load
- Where
- Zimbabwe
- Volunteers
- 451 people
- Sponsor
- Biomedical Research and Training Institute, Zimbabwe
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
Sarcoma, Kaposi, HIV Infections
A Phase I Study of the Combination of Recombinant GM-CSF, AZT, and Chemotherapy (ABV) (Adriamycin, Bleomycin, Vincristine) in AIDS and Kaposi's Sarcoma
To determine the safety as well as the most effective dose of sargramostim (GM-CSF; granulocyte-macrophage colony stimulating factor) that will prevent the side effects caused by the combined use of zidovudine (AZT) and various…
- Trial name
- NCT00000681
- Testing
- Bleomycin sulfate, Vincristine sulfate, Doxorubicin hydrochloride
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
The Safety and Effects of 1592U89 Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Infants and Children
To assess the steady state pharmacokinetic features, tolerance, and safety of orally administered 1592U89, given alone or in combination with other antiretroviral medications, in HIV infected infants and children.
- Trial name
- NCT00000865
- Testing
- Abacavir sulfate, Lamivudine, Stavudine
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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-1-infection
Impact of V106I on Resistance to Doravirine
Objective. To study the impact of V106I mutation in the reverse transcriptase of HIV-1 on the activity of Doravirine. Clinical hypotheses.
- Trial name
- V106IFC (NCT04894357)
- Testing
- Phenotypic resistance measure
- Volunteers
- 50 people
- Sponsor
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
HIV Infections, Pregnancy
Shortened Zidovudine Regimens to Prevent Mother-to-Child Transmission of HIV Type 1
The purpose of the study was to test the equivalence of a short zidovudine (ZDV) regimen as compared to a longer, ACTG-076-like, ZDV regimen in reducing the risk of mother-to-child transmission of HIV: and to assess and compare…
- Trial name
- NCT00386230
- Testing
- ZDV Short (mother)-Short (infant): Comparison of zidovudine durations, ZDV Short (mother)-Long (infant): Comparison of zidovudine durations, ZDV Long (mother)-Short (infant): Comparison of zidovudine durations
- Where
- Thailand
- Volunteers
- 1,554 people
- Sponsor
- Institut de Recherche pour le Developpement
Hepatitis C
Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
This is a Phase I/II, multi-site, open-label, single arm study to describe the pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB) initiated during pregnancy in women with hepatitis C virus (HCV) infection…
- Trial name
- NCT07040319
- Testing
- Glecaprevir/pibrentasvir
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, Influenza
Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents
The purpose of this study is to compare two flu vaccines to determine their safety and ability to stimulate an immune response in HIV infected children and adolescents.
- Trial name
- NCT00091702
- Testing
- Cold-adapted live attenuated influenza vaccine (FluMist), Inactivated influenza vaccine (IAIV)
- Where
- 61 sites in United States, Puerto Rico
- Volunteers
- 300 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)