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Study to Assess the Seroprevalence of Anti-Tat Antibodies in HIV-infected Patients (ISS OBS T-004)

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ClinicalTrials.gov Identifier: NCT01359800
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : March 4, 2016
Sponsor:
Collaborator:
Italian Ministry of Foreign Affairs - Dir. Gen. for Cooperation and Development
Information provided by (Responsible Party):
Barbara Ensoli, MD, Istituto Superiore di Sanità

Tracking Information
First Submitted Date May 17, 2011
First Posted Date May 25, 2011
Last Update Posted Date March 4, 2016
Study Start Date October 2010
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 24, 2011)
Anti-Tat Antibody Responses [ Time Frame: Up to 14 months ]
Assessment of serum anti-Tat antibodies. Anti-Tat humoral immune response will include the determination of serum IgM, IgG and IgA antibodies against both clade B- and C-derived Tat proteins and titration of IgM, IgG and IgA anti-Tat antibodies.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01359800 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 3, 2016)
  • Virological status of anti-Tat positive and negative participants [ Time Frame: Up to 14 months ]
    HIV viral load and clinical status on anti-Tat+ versus anti-Tat- participants. The effect of ARV treatment non-compliance on viral load in anti-Tat+ versus anti-Tat- participants has been evaluated within the ARV-treated study group on the basis of the relevant available information. Hepatitis B, Syphilis, HPV co-infections Assessment.
  • Immunological status of anti-Tat positive and negative participants [ Time Frame: Up to 14 months ]
    Assessment of CD4 T cell counts. Exploratory immunological assays may be performed on available residual samples for a more in-depth characterisation of the immune response.
  • Immune activation status of anti-Tat positive and negative participants [ Time Frame: Up to 14 months ]
    Assessment of Immune-activation markers on CD4+ and CD8+ T cells (CD25+, CD38+ and HLA-DR+).
Original Secondary Outcome Measures
 (submitted: May 24, 2011)
  • Virological status of anti-Tat positive and negative participants [ Time Frame: Up to 14 months ]
    HIV viral load and clinical status on anti-Tat+ versus anti-Tat- participants. The effect of ARV treatment non-compliance on viral load in anti-Tat+ versus anti-Tat- participants will be evaluated within the ARV-treated study group on the basis of the relevant available information. Hepatitis B, Syphilis, HPV co-infections Assessment.
  • Immunological status of anti-Tat positive and negative participants [ Time Frame: Up to 14 months ]
    Assessment of CD4 T cell counts. Exploratory immunological assays may be performed on available residual samples for a more in-depth characterisation of the immune response.
  • Immune activation status of anti-Tat positive and negative participants [ Time Frame: Up to 14 months ]
    Assessment of Immune-activation markers on CD4+ and CD8+ T cells (CD25+, CD38+ and HLA-DR+).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study to Assess the Seroprevalence of Anti-Tat Antibodies in HIV-infected Patients
Official Title A Multicentre, Observational, Cross-sectional Study to Assess the Seroprevalence of Anti-Tat Antibodies in HIV-infected Patients in Selected Areas of Gauteng and Eastern Cape
Brief Summary

Tat is a key HIV regulatory protein produced very early after infection, prior to virus integration, and necessary for viral gene expression, cell-to-cell virus transmission and disease progression. Previous studies in natural HIV infection, indicated that the presence of a Tat-specific immune response correlates with a lower incidence and reduced risk of progression to AIDS as compared to anti-Tat negative individuals suggesting that an immune response to Tat may exert a protective role and control the progression to AIDS in vivo.

On the basis of the above mentioned consideration, the present study was directed at investigating the seroprevalence of anti-Tat antibodies in HIV-infected South African patients.

Detailed Description

This is an observational, cross-sectional study aimed at assessing the frequency, magnitude and quality of the anti-Tat antibody response in both antiretroviral (ARV)-treated and treatment-naïve HIV-infected South African adults, and at exploring the correlation between the presence of anti-Tat antibody response and the immunological status of participants as well as with the presence of co-infections such as HBV, syphilis and HPV (the latter only for female participants).

The study has involved 531 participants and provided important information for the planning, design and conduction of future therapeutic clinical trials with the Tat-based HIV vaccine in South African individuals.

This study is conducted in the frame of the Government-to-Government cooperation program N. AID 8421, funded by the Italian Ministry of Foreign Affairs-Directorate General for Development Cooperation (MAE-DGCS) and jointly implemented by the Italian Istituto Superiore di Sanita' (ISS) and the South African Department of Health in collaboration with the South African AIDS Vaccine Initiative of the Medical Research Council (MRC-SAAVI)

Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, cervical samples
Sampling Method Non-Probability Sample
Study Population HIV positive, ARV-treated and treatment-naïve participants.
Condition HIV Infection
Intervention Not Provided
Study Groups/Cohorts
  • Treatment-naive HIV+ subjects
  • HAART-treated HIV+ subjects
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 3, 2016)
531
Original Estimated Enrollment
 (submitted: May 24, 2011)
700
Actual Study Completion Date July 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • HIV-infected individuals Aged 18-45 years Participants enrolled into the ARV-treated group must have been on treatment for not less than 3 months.

Exclusion Criteria:

  • Unwillingness to consent to study inclusion
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries South Africa
Removed Location Countries  
 
Administrative Information
NCT Number NCT01359800
Other Study ID Numbers ISS OBS T-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Barbara Ensoli, MD, Istituto Superiore di Sanità
Study Sponsor Barbara Ensoli, MD
Collaborators Italian Ministry of Foreign Affairs - Dir. Gen. for Cooperation and Development
Investigators
Study Director: Barbara BE Ensoli, MD PhD Istituto Superiore di Sanità
PRS Account Istituto Superiore di Sanità
Verification Date March 2016