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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00183261




Registration number
NCT00183261
Ethics application status
Date submitted
13/09/2005
Date registered
16/09/2005
Date last updated
1/11/2021

Titles & IDs
Public title
Immune Response to a Therapeutic HIV Vaccine Followed by Treatment Interruption in Patients With Acute or Recent HIV Infection
Scientific title
A Randomized Phase II Study of Therapeutic Immunization and Treatment Interruption Among Subjects Who Began Potent Antiretroviral Therapy Within 30 Days of Diagnosis of Acute or Recent HIV Infection
Secondary ID [1] 0 0
10025
Secondary ID [2] 0 0
AIN504/A5218
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
Infection 0 0 0 0
Sexually transmitted infections
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - MRKAd5 HIV-1 gag/pol/nef
Treatment: Other - MRKAd5 HIV-1 gag/pol/nef placebo

Experimental: 1 - Participants will receive the MRKAd5 HIV-1 gag/pol/nef vaccine at study entry and on Weeks 4 and 26

Placebo comparator: 2 - Participants will receive the MRKAd5 HIV-1 gag/pol/nef vaccine placebo at study entry and on Weeks 4 and 26


Treatment: Other: MRKAd5 HIV-1 gag/pol/nef
1.5 x 1010 Ad vg/mL, 1.0 mL administered intramuscularly

Treatment: Other: MRKAd5 HIV-1 gag/pol/nef placebo
1.0 mL administered intramuscularly
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Average of log10 HIV-1 RNA viral load
Timepoint [1] 0 0
At Weeks 58 and 63
Primary outcome [2] 0 0
Frequency of Grade 3 or 4 systemic adverse events, the occurrence of a severe or life-threatening injection site adverse event, or death
Timepoint [2] 0 0
Throughout study
Secondary outcome [1] 0 0
Distribution of plasma HIV RNA viral load
Timepoint [1] 0 0
At Weeks 63 and 87
Secondary outcome [2] 0 0
Proportion of patients with controlled viremia and their respective distribution of plasma HIV RNA viral load
Timepoint [2] 0 0
At Weeks 63 and 87
Secondary outcome [3] 0 0
Mean viral burden, defined as time-averaged area under the log10 HIV-1 RNA viral load curve
Timepoint [3] 0 0
At Weeks 63 and 87
Secondary outcome [4] 0 0
HIV DNA levels
Timepoint [4] 0 0
At Weeks 30, 38, 63, and 87
Secondary outcome [5] 0 0
HIV-1 DNA levels
Timepoint [5] 0 0
At Weeks 30, 38, 46, 50, 63, and 87
Secondary outcome [6] 0 0
Magnitude and absolute change in CD4 and CD8 counts
Timepoint [6] 0 0
At Weeks 63 and 87
Secondary outcome [7] 0 0
Percent and absolute change in the number of HIV-1- specific CD8 cells, as measured by interferon (IFN)-gamma Elispot assay and intracellular cytokine staining
Timepoint [7] 0 0
Through Week 30
Secondary outcome [8] 0 0
Percent and absolute change in the cytokine secretion patterns and the proliferative capacity of HIV-1- specific CD4 and CD8 cells, as measured by multiparameter flow cytometry
Timepoint [8] 0 0
Through Week 30
Secondary outcome [9] 0 0
Breadth and magnitude of HIV-1- specific CD4 and CD8 cell responses
Timepoint [9] 0 0
Throughout study
Secondary outcome [10] 0 0
Time to reach the specified virologic or immunologic criteria for reinitiating antiretroviral therapy after treatment interruption
Timepoint [10] 0 0
Throughout study
Secondary outcome [11] 0 0
Frequency of Grade 3 or 4 systemic adverse events or the occurrence of a severe or life-threatening injection site adverse event, or HIV-related events, AIDS-defining infections, and death from time of vaccination
Timepoint [11] 0 0
Throughout study
Secondary outcome [12] 0 0
Cell-associated infectivity in latently infected cells
Timepoint [12] 0 0
At Week 63
Secondary outcome [13] 0 0
Cell-associated infectivity at Week 63 and immunologic responses
Timepoint [13] 0 0
At Weeks 63 and 87

Eligibility
Key inclusion criteria
* Initiated HAART within 30 days of an acute or recent HIV-1 infection diagnosis. More information on this criterion can be found in the protocol.
* Initiated HAART within 30 days of documented acute or recent HIV-1 infection without interruption for more than 7 days
* Sustained viral suppression, defined as a viral load of 500 copies/mL or less 12 months prior to baseline with an undetectable HIV-1 RNA viral load between 60 to 7 days prior to baseline
* CD4 count of 450 cells/mm3 or more OR 35% or more between 60 to 14 days prior to baseline
* Ad5 neutralizing antibody titer of 200 or less at screening
* Willing to follow all study procedures and schedules
* Willing to interrupt HAART for at least 24 weeks following completion of the vaccination stage
* Negative for hepatitis B surface antigen (HBsAg) at screening
* Willing to use acceptable forms of contraception
* Infected with HIV-1 subtype B, if this information is available
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Virologic relapse, defined as 2 consecutive measurements of viral load of 500 copies/mL or more at least 7 days apart within 12 months of baseline visit
* Received more than 7 days of continuous HAART other than that received within 16 days of acute or recent HIV-1 infection. Participants who received HAART as part of post-exposure prophylaxis (PEP) more than 6 months prior to the start of initial HAART may be eligible, provided that they did not acquire HIV-1 infection from the event that required PEP.
* History of anaphylaxis or allergy to vaccine components, including Tris buffer, magnesium chloride, and polysorbate 80 (Tween)
* History of clinically significant heart, lung, kidney, liver, pancreatic, gastrointestinal, or neurological disease that, in the opinion of the study investigator, may interfere with the study
* Contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia
* Receipt of any immune globulin or blood products within 3 months prior to baseline
* Receipt of any live vaccine within 30 days prior to baseline or any inactivated vaccine within 14 days prior to baseline
* Previous receipt of any HIV vaccine. Participants that were documented to have received only placebo are not excluded.
* History of any AIDS-defining illness. If a participant's sole AIDS-defining illness is Kaposi's sarcoma limited to the skin and is not anticipated to require systemic chemotherapy, that participant is not excluded.
* Currently receiving drugs or biologics not approved by the Food and Drug Administration (FDA) other than investigational HIV medications
* Current or past participation in other studies that might alter the participant's response to the study vaccination
* Use of any immunomodulatory agents, including but not limited to interleukin-2 (IL-2), granulocyte/macrophage-colony stimulating factor (GM-CSF), and systemic corticosteroids, within 30 days prior to baseline
* Active alcohol or substance use that, in the investigator's opinion, may interfere with the study
* Any other criteria or condition that, in the investigator's opinion, may interfere with the study
* Unwilling or unable to contribute to the planned peripheral blood mononuclear cell (PBMC) blood collection
* Pregnancy or breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice CRS - Darlinghurst
Recruitment hospital [2] 0 0
St. Vincent's Hospital CRS - Darlinghurst
Recruitment hospital [3] 0 0
Taylor Square Private Clinic CRS - Darlinghurst
Recruitment hospital [4] 0 0
AIDS Research Initiative, Darlinghurst CRS - Darlinghurst
Recruitment hospital [5] 0 0
407 Doctors (Australia) AIEDRP - Sydney
Recruitment hospital [6] 0 0
AIDS Research Initiative (Australia) AIEDRP - Sydney
Recruitment hospital [7] 0 0
St. Vincent's Hosp. (Australia) AIEDRP - Sydney
Recruitment hospital [8] 0 0
Taylor Square Private Clinic (Australia) AIEDRP - Sydney
Recruitment hospital [9] 0 0
Holdsworth House Gen. Practice (Australia) AIEDRP - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
- Sydney
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
Colorado
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
Missouri
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
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Rhode Island
Country [8] 0 0
American Samoa
State/province [8] 0 0
Surry Hills

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases (NIAID)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Acute Infection and Early Disease Research Program
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Susan Little, MD
Address 0 0
University of California, San Diego AIDS Vaccine Research Center
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00183261