Viral and Immunologic Factors Contributing to the Lack of HIV Transmission Among Couples in Rakai, Uganda

NCT00342160 | Completed

• 2 other identifiers: 99990610006-I-N100
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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 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:

• HIV counseling and testing
• Medical history, including questions about personal behaviors such as sexual practices and use of condoms
• Blood sample collection
• Urine sample collection
• Vaginal swab for women 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. ...

Conditions

HIV

Keywords

AIDS; HIV Infectiousness; Immunity; CTL; Epidemiology

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Uganda Virus Research Institute

Rakai, Uganda

Location

Related Publications (3)

• Blocker ME, Cohen MS. Biologic approaches to the prevention of sexual transmission of human immunodeficiency virus. Infect Dis Clin North Am. 2000 Dec;14(4):983-99. doi: 10.1016/s0891-5520(05)70143-4.

  PMID: 11144648 BACKGROUND

• Quinn TC, Wawer MJ, Sewankambo N, Serwadda D, Li C, Wabwire-Mangen F, Meehan MO, Lutalo T, Gray RH. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med. 2000 Mar 30;342(13):921-9. doi: 10.1056/NEJM200003303421303.

  PMID: 10738050 BACKGROUND

• Vernazza PL, Troiani L, Flepp MJ, Cone RW, Schock J, Roth F, Boggian K, Cohen MS, Fiscus SA, Eron JJ. Potent antiretroviral treatment of HIV-infection results in suppression of the seminal shedding of HIV. The Swiss HIV Cohort Study. AIDS. 2000 Jan 28;14(2):117-21. doi: 10.1097/00002030-200001280-00006.

  PMID: 10708281 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas C Quinn, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: February 15, 2006
• Study Completion: November 13, 2012
• Last Updated: December 16, 2019

Record last verified: 2012-11-13

Locations

UG (1)