Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001119
Status:
COMPLETED
Last Update Posted:
2011-03-02
First Post:
1999-11-02
Brief Title:
Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Study of the Effects of Combination Antiretroviral Therapy in Acute HIV-1 Infection With an Emphasis on Immunological Responses
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out whether these powerful combinations of anti-HIV drugs are safe and effective for use in patients in the early stages of HIV infection and to find out how patients immune systems react to HIV and anti-HIV drugs
Doctors generally treat patients in the early stages of HIV infection with the same anti-HIV drugs taken by patients who have had HIV for a long time These drugs lower the level of HIV in the blood However doctors do not know whether patients who take anti-HIV drugs in the early stages of HIV infection actually live longer or have fewer AIDS-related diseases This study will help doctors answer these questions In the main study doctors will look at how 2 different anti-HIV drug combinations affect the immune system In the 2 substudies doctors will look at how the body reacts to the hepatitis B vaccine and the tetanus vaccine These substudies may help doctors learn how HIV-infected patients respond to new infections
Doctors generally treat patients in the early stages of HIV infection with the same anti-HIV drugs taken by patients who have had HIV for a long time These drugs lower the level of HIV in the blood However doctors do not know whether patients who take anti-HIV drugs in the early stages of HIV infection actually live longer or have fewer AIDS-related diseases This study will help doctors answer these questions In the main study doctors will look at how 2 different anti-HIV drug combinations affect the immune system In the 2 substudies doctors will look at how the body reacts to the hepatitis B vaccine and the tetanus vaccine These substudies may help doctors learn how HIV-infected patients respond to new infections
Detailed Description:
Current treatment guidelines recommend combination ART for acute primary HIV-1 infection However it is not known whether ART given during acute infection delays progression to AIDS or improves survival rates Preliminary studies suggest ART given early in HIV infection not only reduces viral load but also restricts CD4 cell loss delays the development of opportunistic infections and preserves T-helper cells and naive T cells The immunologic basis of these protective effects has not been characterized thoroughly This protocol assesses ARTs effects on immune responses in early HIV infection through a variety of cellular humoral and virologic assays including 2 substudies The substudies focus on antibody responses to neoantigen immunization hepatitis B and tetanus Primary endpoint analysis occurs at Week 72 but patients may be followed for long-term outcomes
In the main study patients with HIV-1 infection of less than 120 days are given the option of taking a potent ART combination of abacavir ABC efavirenz EFV indinavir IDV and lamivudine 3TC for 96 weeks AS PER AMENDMENT 91500 Patients choose either Regimen 1 ABC 3TC IDV and ritonavir RTV or Regimen 2 ABC 3TC and EFV Patients who decline treatment provide a concurrent non-randomized comparison group These patients may choose to be considered for study treatment at any time or to start antiretrovirals provided through another source AS PER AMENDMENT 91500 If a patient who initially does not start therapy subsequently starts antiretroviral therapy provided by the study within the 120-day limit the visit schedule is re-set During the treatment period all patients undergo regular physical exams and blood tests to characterize T cells viral resistance antibody responses and other markers Patients presenting within 30 days of HIV-1 infection undergo leukapheresis where available prior to starting ART At Month 12 these patients and all untreated patients undergo leukapheresis to assess the proportion of latently infected CD4 T cells In addition all patients in the main study and patients in 2 comparison groups Cohorts A and B participate in 1 of 2 substudies of antibody responses to neoantigen Volunteers are recruited to 2 cohorts to serve as controls Cohort A volunteers have established HIV-1 infection Cohort B volunteers are HIV-1 seronegative but at high risk for HIV In the first substudy hepatitis B-seronegative patients from the main study and from Cohorts A and B receive hepatitis B vaccine at Weeks 40 44 and 64 and undergo humoral and cellular response assessments at Week 68 In the second substudy patients from the main study and from Cohorts A and B who did not qualify for the hepatitis B vaccination undergo intramuscular vaccination with tetanus toxoid at Week 64 and immune responses are assessed at Week 68 Volunteers in Cohorts A and B receive no anti-HIV medication as part of these substudies
In the main study patients with HIV-1 infection of less than 120 days are given the option of taking a potent ART combination of abacavir ABC efavirenz EFV indinavir IDV and lamivudine 3TC for 96 weeks AS PER AMENDMENT 91500 Patients choose either Regimen 1 ABC 3TC IDV and ritonavir RTV or Regimen 2 ABC 3TC and EFV Patients who decline treatment provide a concurrent non-randomized comparison group These patients may choose to be considered for study treatment at any time or to start antiretrovirals provided through another source AS PER AMENDMENT 91500 If a patient who initially does not start therapy subsequently starts antiretroviral therapy provided by the study within the 120-day limit the visit schedule is re-set During the treatment period all patients undergo regular physical exams and blood tests to characterize T cells viral resistance antibody responses and other markers Patients presenting within 30 days of HIV-1 infection undergo leukapheresis where available prior to starting ART At Month 12 these patients and all untreated patients undergo leukapheresis to assess the proportion of latently infected CD4 T cells In addition all patients in the main study and patients in 2 comparison groups Cohorts A and B participate in 1 of 2 substudies of antibody responses to neoantigen Volunteers are recruited to 2 cohorts to serve as controls Cohort A volunteers have established HIV-1 infection Cohort B volunteers are HIV-1 seronegative but at high risk for HIV In the first substudy hepatitis B-seronegative patients from the main study and from Cohorts A and B receive hepatitis B vaccine at Weeks 40 44 and 64 and undergo humoral and cellular response assessments at Week 68 In the second substudy patients from the main study and from Cohorts A and B who did not qualify for the hepatitis B vaccination undergo intramuscular vaccination with tetanus toxoid at Week 64 and immune responses are assessed at Week 68 Volunteers in Cohorts A and B receive no anti-HIV medication as part of these substudies
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: