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

Purpose

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.

Condition
HIV Infection


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Istituto Superiore di Sanità:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Virological status of anti-Tat positive and negative participants [ Time Frame: Up to 14 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Assessment of Immune-activation markers on CD4+ and CD8+ T cells (CD25+, CD38+ and HLA-DR+).

Biospecimen Retention: Samples With DNA

Whole blood, cervical samples


Enrollment:	530
Study Start Date:	October 2010
Study Completion Date:	July 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
Treatment-naive HIV+ subjects
HAART-treated HIV+ subjects

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 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)

Eligibility


Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

HIV positive, ARV-treated and treatment-naïve participants.

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359800

Locations


South Africa
Walter Sisulu University HIV Vaccine Research Unit
Mthatha, Eastern Cape, South Africa
Medunsa Clinical Reasearch Unit
Medunsa, Gauteng, South Africa

Sponsors and Collaborators

Istituto Superiore di Sanità

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

Investigators


Study Director:	Barbara BE Ensoli, MD PhD	Istituto Superiore di Sanità

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Ensoli B, Fiorelli V, Ensoli F, Lazzarin A, Visintini R, Narciso P, Di Carlo A, Tripiciano A, Longo O, Bellino S, Francavilla V, Paniccia G, Arancio A, Scoglio A, Collacchi B, Ruiz Alvarez MJ, Tambussi G, Tassan Din C, Palamara G, Latini A, Antinori A, D'Offizi G, Giuliani M, Giulianelli M, Carta M, Monini P, Magnani M, Garaci E. The preventive phase I trial with the HIV-1 Tat-based vaccine. Vaccine. 2009 Dec 11;28(2):371-8. doi: 10.1016/j.vaccine.2009.10.038. Epub 2009 Oct 29.

Longo O, Tripiciano A, Fiorelli V, Bellino S, Scoglio A, Collacchi B, Alvarez MJ, Francavilla V, Arancio A, Paniccia G, Lazzarin A, Tambussi G, Din CT, Visintini R, Narciso P, Antinori A, D'Offizi G, Giulianelli M, Carta M, Di Carlo A, Palamara G, Giuliani M, Laguardia ME, Monini P, Magnani M, Ensoli F, Ensoli B. Phase I therapeutic trial of the HIV-1 Tat protein and long term follow-up. Vaccine. 2009 May 26;27(25-26):3306-12. doi: 10.1016/j.vaccine.2009.01.090. Epub 2009 Feb 7.

Ensoli B, Bellino S, Tripiciano A, Longo O, Francavilla V, Marcotullio S, Cafaro A, Picconi O, Paniccia G, Scoglio A, Arancio A, Ariola C, Ruiz Alvarez MJ, Campagna M, Scaramuzzi D, Iori C, Esposito R, Mussini C, Ghinelli F, Sighinolfi L, Palamara G, Latini A, Angarano G, Ladisa N, Soscia F, Mercurio VS, Lazzarin A, Tambussi G, Visintini R, Mazzotta F, Di Pietro M, Galli M, Rusconi S, Carosi G, Torti C, Di Perri G, Bonora S, Ensoli F, Garaci E. Therapeutic immunization with HIV-1 Tat reduces immune activation and loss of regulatory T-cells and improves immune function in subjects on HAART. PLoS One. 2010 Nov 11;5(11):e13540. doi: 10.1371/journal.pone.0013540.

Bellino S, Francavilla V, Longo O, Tripiciano A, Paniccia G, Arancio A, Fiorelli V, Scoglio A, Collacchi B, Campagna M, Lazzarin A, Tambussi G, Din CT, Visintini R, Narciso P, Antinori A, D'Offizi G, Giulianelli M, Carta M, Di Carlo A, Palamara G, Giuliani M, Laguardia ME, Monini P, Magnani M, Ensoli F, Ensoli B. Parallel conduction of the phase I preventive and therapeutic trials based on the Tat vaccine candidate. Rev Recent Clin Trials. 2009 Sep;4(3):195-204. Review.

Ensoli B, Fiorelli V, Ensoli F, Lazzarin A, Visintini R, Narciso P, Di Carlo A, Monini P, Magnani M, Garaci E. The therapeutic phase I trial of the recombinant native HIV-1 Tat protein. AIDS. 2008 Oct 18;22(16):2207-9. doi: 10.1097/QAD.0b013e32831392d4.

Ensoli B, Fiorelli V, Ensoli F, Cafaro A, Titti F, Buttò S, Monini P, Magnani M, Caputo A, Garaci E. Candidate HIV-1 Tat vaccine development: from basic science to clinical trials. AIDS. 2006 Nov 28;20(18):2245-61. Review.

Buttò S, Fiorelli V, Tripiciano A, Ruiz-Alvarez MJ, Scoglio A, Ensoli F, Ciccozzi M, Collacchi B, Sabbatucci M, Cafaro A, Guzmán CA, Borsetti A, Caputo A, Vardas E, Colvin M, Lukwiya M, Rezza G, Ensoli B; Tat Multicentric Study Group. Sequence conservation and antibody cross-recognition of clade B human immunodeficiency virus (HIV) type 1 Tat protein in HIV-1-infected Italians, Ugandans, and South Africans. J Infect Dis. 2003 Oct 15;188(8):1171-80. Epub 2003 Sep 30.

Rezza G, Fiorelli V, Dorrucci M, Ciccozzi M, Tripiciano A, Scoglio A, Collacchi B, Ruiz-Alvarez M, Giannetto C, Caputo A, Tomasoni L, Castelli F, Sciandra M, Sinicco A, Ensoli F, Buttò S, Ensoli B. The presence of anti-Tat antibodies is predictive of long-term nonprogression to AIDS or severe immunodeficiency: findings in a cohort of HIV-1 seroconverters. J Infect Dis. 2005 Apr 15;191(8):1321-4. Epub 2005 Mar 14.


Responsible Party:	Dr. Barbara Ensoli, Istituto Superiore di Sanita
ClinicalTrials.gov Identifier:	NCT01359800 History of Changes
Other Study ID Numbers:	ISS OBS T-004
Study First Received:	May 17, 2011
Last Updated:	March 19, 2014
Health Authority:	South Africa: Human Research Ethics Committee

Keywords provided by Istituto Superiore di Sanità:


HIV HAART

ClinicalTrials.gov processed this record on March 03, 2015

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