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
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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.
Condition or disease |
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HIV Infection |
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 |
Actual Enrollment : | 531 participants |
Time Perspective: | Cross-Sectional |
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 |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | July 2013 |

Group/Cohort |
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Treatment-naive HIV+ subjects |
HAART-treated HIV+ subjects |
- 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.
- 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+).
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359800
South Africa | |
Walter Sisulu University HIV Vaccine Research Unit | |
Mthatha, Eastern Cape, South Africa | |
Mecru Clinical Research Unit (MeCRU) | |
Medunsa, Gauteng, South Africa |
Study Director: | Barbara BE Ensoli, MD PhD | Istituto Superiore di Sanità |
Additional Information:
Publications:
Responsible Party: | Barbara Ensoli, MD, PhD, Istituto Superiore di Sanità |
ClinicalTrials.gov Identifier: | NCT01359800 History of Changes |
Other Study ID Numbers: |
ISS OBS T-004 |
First Posted: | May 25, 2011 Key Record Dates |
Last Update Posted: | March 4, 2016 |
Last Verified: | March 2016 |
Keywords provided by Barbara Ensoli, MD, Istituto Superiore di Sanità:
HIV HAART |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Antibodies Immunologic Factors Physiological Effects of Drugs |