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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00001119




Registration number
NCT00001119
Ethics application status
Date submitted
2/11/1999
Date registered
31/08/2001
Date last updated
2/03/2011

Titles & IDs
Public title
Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV
Scientific title
A Study of the Effects of Combination Antiretroviral Therapy in Acute HIV-1 Infection With an Emphasis on Immunological Responses
Secondary ID [1] 0 0
AIEDRP AI-02-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Tetanus Toxoid Vaccine
Treatment: Drugs - Indinavir sulfate
Treatment: Drugs - Lamivudine/Zidovudine
Treatment: Drugs - Ritonavir
Treatment: Drugs - Abacavir sulfate
Treatment: Drugs - Amprenavir
Treatment: Drugs - Efavirenz
Other interventions - Hepatitis B Vaccine (Recombinant)
Treatment: Drugs - Lamivudine
Treatment: Drugs - Zidovudine

Other interventions: Tetanus Toxoid Vaccine


Treatment: Drugs: Indinavir sulfate


Treatment: Drugs: Lamivudine/Zidovudine


Treatment: Drugs: Ritonavir


Treatment: Drugs: Abacavir sulfate


Treatment: Drugs: Amprenavir


Treatment: Drugs: Efavirenz


Other interventions: Hepatitis B Vaccine (Recombinant)


Treatment: Drugs: Lamivudine


Treatment: Drugs: Zidovudine
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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).
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Saint Vincent's Hosp Med Centre - Darlinghurst
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Rhode Island
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases (NIAID)
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00001119
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lawrence Corey
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00001119