Study to Assess the Seroprevalence of Anti-Tat Antibodies in HIV-infected Patients (ISS OBS T-004)
Recruitment status was Recruiting
|First Received Date ICMJE||May 17, 2011|
|Last Updated Date||May 24, 2011|
|Start Date ICMJE||October 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Anti-Tat Antibody Responses [ Time Frame: Up to 14 months ] [ Designated as safety issue: No ]
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 ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01359800 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Study to Assess the Seroprevalence of Anti-Tat Antibodies in HIV-infected Patients|
|Official Title ICMJE||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|
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 is directed at investigating the seroprevalence of anti-Tat antibodies in HIV-infected South African patients.
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 will involve 700 participants and will provide 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 ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Cross-Sectional|
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples With DNA
Whole blood, cervical samples
|Sampling Method||Non-Probability Sample|
HIV positive, ARV-treated and treatment-naïve participants.
|Condition ICMJE||HIV Infection|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||700|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 45 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Not Provided|
|Location Countries ICMJE||South Africa|
|NCT Number ICMJE||NCT01359800|
|Other Study ID Numbers ICMJE||ISS OBS T-004|
|Has Data Monitoring Committee||No|
|Responsible Party||Dr. Barbara Ensoli, Istituto Superiore di Sanita|
|Study Sponsor ICMJE||Istituto Superiore di Sanita|
|Collaborators ICMJE||Italian Ministry of Foreign Affairs - Dir. Gen. for Cooperation and Development|
|Information Provided By||Istituto Superiore di Sanita|
|Verification Date||April 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP