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Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV

NCT00001119 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2011-03-02

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

Tetanus Toxoid Vaccine

DRUG

Indinavir sulfate

DRUG

Lamivudine/Zidovudine

DRUG

Ritonavir

DRUG

Abacavir sulfate

DRUG

Amprenavir

DRUG

Efavirenz

BIOLOGICAL

Hepatitis B Vaccine (Recombinant)

DRUG

Lamivudine

DRUG

Zidovudine

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Lawrence Corey

Study Design

Purpose
TREATMENT

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-10-31
Primary Completion
2004-06-30

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00001119 on ClinicalTrials.gov