Viral and Immunologic Factors Contributing to the Lack of HIV Transmission Among Couples in Rakai, Uganda
|First Received Date ICMJE||June 19, 2006|
|Last Updated Date||January 14, 2014|
|Start Date ICMJE||February 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00342160 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Viral and Immunologic Factors Contributing to the Lack of HIV Transmission Among Couples in Rakai, Uganda|
|Official Title ICMJE||Virologic and Immunologic Factors Contributing to the Lack of HIV-1 Transmission in HIV-Discordant Couples in Rakai, Uganda|
This study will look at viral and immunologic factors involved in protecting against sexually transmitted HIV infection in couples in which one partner is infected and the other is not.
This study will include 50 couples who reside in Rakai, Uganda, and who have been together for at least 2 years. In some couples, both partners will be HIV-infected, in some couples only one partner will have HIV, and in some couples neither partner will have HIV.
Participants undergo the following procedures at each of four study visits:
Blood, urine and vaginal fluid samples are tested for HIV and other sexually transmitted diseases, such as syphilis. Blood and vaginal samples are also tested for HIV viral levels and immune response in HIV-infected individuals and for evidence of exposure to HIV in non-infected participants. Some blood is also tested for genetic markers to investigate whether certain proteins are related to resistance to HIV infection.
|Detailed Description||Understanding the factors that contribute to the transmission of human immunodeficiency virus (HIV) infection is of great importance for the development of preventive and therapeutic strategies. Evidence suggests that a number of host immunologic and virologic factors play critical roles in protection against sexually transmitted HIV infection in HIV-discordant partners. Among these, the antiviral role of CD8+ T cells in HIV-infected individuals has been extensively studied. At least two types of CD8+ T cell-mediated antiviral activities have been described in HIV infection. The first is a suppressive activity against HIV involving lysis of infected cells in an antigen-specific, HLA-restricted fashion, while the second mechanism inhibits viral replication via either cell- or soluble mediated factors in the absence of cell killing. It has been demonstrated that cytotoxic CD8+ T lymphocytes (CTL) are present in both cervical and peripheral blood mononuclear cells (PBMC) from a subpopulation of highly-HIV-exposed but persistently seronegative individuals. However, studies addressing the effect of non-cytotoxic soluble factor-mediated antiviral activity by CD8+ T cells in preventing seroconversion in HIV-discordant couples have been lacking. This study proposes to examine the role of CD8+ T cell-derived CC-chemokine activities and the copy numbers of one of the chemokine genes, CCL3L1, along with other host anti-HIV and virologic factors in resistance to HIV infection in persistently seronegative HIV-discordant partners of HIV infected individuals.|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||100|
|Completion Date||November 2012|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Group 1 (HIV concordant partners, n = 20 couples):
Group 2 (HIV-discordant partners, n = 20 couples):
Group 3 (HIV-uninfected partners, n = 10 couples):
Inability or unwillingness to provide individual informed consent, on the part of either or both members of the couple.
Refusal of couples counseling on the part of one or both partners.
Severe illness in one or the other, and /or a hemoglobin value less than 8 g/dL.
Age less than 18. Children are not included in this study since it specifically focuses on sexual transmission of HIV in long term married couples.
Having had a blood transfusion within the last 60 days. Though individuals can be scheduled after this time period has passed.
|Ages||18 Years to 65 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Uganda|
|Removed Location Countries||United States|
|NCT Number ICMJE||NCT00342160|
|Other Study ID Numbers ICMJE||999906100, 06-I-N100|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||November 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP