Know Cancer

or
forgot password

A Study of the Effects of Combination Antiretroviral Therapy in Acute HIV-1 Infection With an Emphasis on Immunological Responses


N/A
16 Years
N/A
Not Enrolling
Both
HIV Infections

Thank you

Trial Information

A Study of the Effects of Combination Antiretroviral Therapy in Acute HIV-1 Infection With an Emphasis on Immunological Responses


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 ART's 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 9/15/00: 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 9/15/00: 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.

Inclusion Criteria


Inclusion Criteria

Patients may be eligible for the main study if they:

- Became infected with HIV within the last 120 days.

- Are at least age 16 and have written consent of a parent or guardian if under 18.

- Are willing to practice abstinence or use barrier methods of birth control, such as
condoms.

- Are available for at least 72 weeks.

- Patients may be eligible for 1 of the 2 substudies if they:

- Are at least age 16 and have written consent of a parent or guardian if under 18.

- Have had HIV infection for more than 1 year and have a CD4 cell count greater than
500 cells/mm3, or do not have HIV infection but are at risk of getting HIV because of
their lifestyle, such as sexual activity or injection drug use.

- Have never had hepatitis B infection or a hepatitis B vaccine and they are available
for 28 weeks (hepatitis B vaccine substudy only).

- Have not received a tetanus shot in the past 5 years, have never had an allergic
reaction to a tetanus shot, and are available for 8 weeks (tetanus shot substudy
only).

Exclusion Criteria

Patients will not be eligible for the main study if they:

- Have taken anti-HIV drugs for more than 7 days for the treatment of HIV. However,
anti-HIV drugs taken to help prevent HIV are acceptable.

- Have certain types of cancer.

- Are receiving an experimental treatment.

- Are pregnant or breast-feeding.

- Are allergic to study drugs.

- Have taken certain medications that may interfere with the study.

- Patients will not be eligible for 1 of the 2 substudies if they:

- Are receiving an experimental treatment.

- Are pregnant or breast-feeding.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Principal Investigator

Lawrence Corey

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

AIEDRP AI-02-001

NCT ID:

NCT00001119

Start Date:

October 1999

Completion Date:

Related Keywords:

  • HIV Infections
  • Immunity, Cellular
  • Drug Therapy, Combination
  • HIV Protease Inhibitors
  • Antibody Formation
  • Reverse Transcriptase Inhibitors
  • Anti-HIV Agents
  • Viral Load
  • Tetanus Toxoid
  • Case-Control Studies
  • Hepatitis B Surface Antigens
  • Acute Infection
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

Univ of MinnesotaMinneapolis, Minnesota  55455
Univ of WashingtonSeattle, Washington  98105
Univ of CincinnatiCincinnati, Ohio  452670405
San Francisco Dept of Hlth / AIDS OfficeSan Francisco, California  94102
Univ of Illinois Chicago / Howard Brown Hlth CtrChicago, Illinois  60612
Fenway Community Health Ctr / HIVNETBoston, Massachusetts  02115
Bronx-Lebanon Hosp CtrBronx, New York  10453
New York Univ Med CtrNew York, New York  10016
Mem Hosp of Rhode IslandPawtucket, Rhode Island  02860
Fred Hutchinson Cancer Research CtrSeattle, Washington  98109
Seattle HIVNETSeattle, Washington  98104