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Completed

NCT Number: NCT01359800

Study to Assess the Seroprevalence of Anti-Tat Antibodies in HIV-infected Patients

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Walter Sisulu University HIV Vaccine Research Unit, Mthatha, Eastern Cape, South Africa

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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+).

Sponsors and collaborators

Lead sponsor

Barbara Ensoli, MD

Other

Collaborators

  • Italian Ministry of Foreign Affairs - Dir. Gen. for Cooperation and Development

Registry information

Official study 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

Acronym: ISS OBS T-004

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 25, 2011
Registry last updated
Mar 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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