Status:
COMPLETED
Viral and Immunologic Factors Contributing to the Lack of HIV Transmission Among Couples in Rakai, Uganda
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV
Eligibility:
All Genders
18-65 years
Brief Summary
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 wi...
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. Evide...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Group 1 (HIV concordant partners, n = 20 couples):
- Documentation of HIV infection in both partners, a current history of continued sexual activity within the partnership, and demonstration that they have been in a partnership for at least two years.
- CD4+ T cell count greater than 250/microliters blood in both partners and not currently on HAART.
- Plasma viremia greater than 5,000 copies of HIV RNA/ml plasma in both partners.
- Able and willing to provide informed consent.
- Must agree to continued couple counseling regarding HIV results
- Group 2 (HIV-discordant partners, n = 20 couples):
- Documentation of HIV infection in one partner and seronegative status in the other partner, a current history of continued sexual activity within the partnership, and demonstration that they have been in a partnership for at least two years.
- CD4+ T cell count greater than 250/microliters blood in both partners and not currently on HAART.
- Plasma viremia greater than 5,000 copies of HIV RNA/ml plasma in each infected partner.
- Able and willing to provide informed consent.
- Must agree to continued couple counseling regarding HIV results
- Group 3 (HIV-uninfected partners, n = 10 couples):
- Documentation of HIV-seronegative status in both partners, a current history of continued sexual activity within the partnership, and demonstration that they have been in a partnership for at least two years.
- CD4+ T cell count greater than 250/microliters blood in both partners.
- Able and willing to provide informed consent.
- Must agree to continued couple counseling regarding HIV results
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
February 15 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 13 2012
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00342160
Start Date
February 15 2006
End Date
November 13 2012
Last Update
December 16 2019
Active Locations (1)
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1
Uganda Virus Research Institute
Rakai, Uganda