HIV Infections Clinical Trial
Official title:
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of a Combined Regimen Using ALVAC vCP1452 and AIDSVAX B/B
NCT number | NCT00007332 |
Other study ID # | HVTN 203 |
Secondary ID | AVEG 20310596 |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Est. completion date | April 2003 |
Verified date | October 2021 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to see if the vaccines tested are safe when given alone and when given together, and how the immune system responds to the vaccines. Vaccines are given to people to try to prevent an infection or disease. Early testing in a few people has shown that the HIV vaccines ALVAC vCP1452 and AIDSVAX B/B seem to be safe to use.
Status | Completed |
Enrollment | 330 |
Est. completion date | April 2003 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria Volunteers may be eligible for this study if they: - Are HIV-negative. - Are 18 to 60 years old. - Have a CD4 cell count of 400 cells/mm3 or more. - Agree to use adequate birth control for 1 month before study entry and during the study (female participants). - Have a normal history and physical examination. - Are available for 12 months of follow-up for the planned duration of the study. - Have a negative pregnancy test within 3 days prior to injections. Exclusion Criteria Volunteers will not be eligible for this study if they: - Are pregnant or breast-feeding. - Have chronic hepatitis B. - Are taking medications that affect the immune system. - Have an immune system problem, any long-term illness, or any autoimmune disease. - Have cancer, except if it has been removed with surgery and cure is likely. - Have a physical condition, mental condition, or job or work that may interfere with the study. - Have been suicidal, or have ever needed medicines for a serious mental condition. - Have received certain vaccines within 60 days of study entry. - Have used experimental drugs within 30 days prior to study entry. - Have received any blood products, such as immunoglobulin, in the last 6 months. - Have active syphilis. - Have active tuberculosis. - Have history of severe allergy or any serious reactions to vaccines. - Have had HIV-1 vaccines in a clinical study. |
Country | Name | City | State |
---|---|---|---|
United States | Infectious Diseases Physicians, Inc. | Annandale | Virginia |
United States | Johns Hopkins Bloomberg School of Public Health, Ctr. for Immunization Research, Project SAVE-DC | Baltimore | Maryland |
United States | Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore | Baltimore | Maryland |
United States | Project Brave HIV Vaccine CRS | Baltimore | Maryland |
United States | Alabama Vaccine CRS | Birmingham | Alabama |
United States | Brigham and Women's Hosp. CRS | Boston | Massachusetts |
United States | Fenway Community Health Clinical Research Site (FCHCRS) | Boston | Massachusetts |
United States | NY Blood Ctr./Bronx CRS | Bronx | New York |
United States | Vanderbilt Vaccine CRS | Nashville | Tennessee |
United States | HIV Prevention & Treatment CRS | New York | New York |
United States | NY Blood Ctr./Union Square CRS | New York | New York |
United States | Miriam Hospital's HVTU | Providence | Rhode Island |
United States | Univ. of Rochester HVTN CRS | Rochester | New York |
United States | Saint Louis Univ. School of Medicine, HVTU | Saint Louis | Missouri |
United States | San Francisco Dept. of Public Health, San Francisco Gen. Hosp. | San Francisco | California |
United States | San Francisco Vaccine and Prevention CRS | San Francisco | California |
United States | FHCRC/UW Vaccine CRS | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05454514 -
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
|
N/A | |
Completed |
NCT03760458 -
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
|
Phase 1/Phase 2 | |
Completed |
NCT03067285 -
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
|
Phase 4 | |
Completed |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
|
N/A | |
Recruiting |
NCT04579146 -
Coronary Artery Disease (CAD) in Patients HIV-infected
|
||
Completed |
NCT06212531 -
Papuan Indigenous Model of Male Circumcision
|
N/A | |
Active, not recruiting |
NCT03256422 -
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
|
Phase 3 | |
Completed |
NCT03256435 -
Retention in PrEP Care for African American MSM in Mississippi
|
N/A | |
Completed |
NCT00517803 -
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
|
N/A | |
Active, not recruiting |
NCT03572335 -
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
|
||
Completed |
NCT04165200 -
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
|
N/A | |
Recruiting |
NCT03854630 -
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
|
Phase 4 | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT02234882 -
Study on Pharmacokinetics
|
Phase 1 | |
Completed |
NCT01618305 -
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
|
Phase 4 | |
Recruiting |
NCT05043129 -
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
|
||
Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
|
N/A | |
Recruiting |
NCT04985760 -
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
|
Phase 1 | |
Completed |
NCT05916989 -
Stimulant Use and Methylation in HIV
|
||
Terminated |
NCT02116660 -
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
|
Phase 2 |