Status:
COMPLETED
Examining Factors That May Influence Resistance to HIV-1 Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Center for HIV/AIDS Vaccine Immunology
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
Some people who are exposed to the HIV-1 virus are capable of either controlling or completely preventing viral infection. Multiple genetic factors may contribute to preventing or controlling HIV-1 in...
Detailed Description
Even with repeated exposure to HIV-1, some individuals appear to be resistant to infection. The exact mechanism of this resistance, however, remains unknown. The relative risk of HIV-1 infection appea...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Groups 1, 2, and 3:
- Willing to provide adequate location information
- Planning to remain in the area for the duration of the study
- Inclusion Criteria for Group 1:
- HIV-1 antibody positive AND nucleic acid test (NAT) or p24 antigen negative
- Report unprotected receptive or insertive vaginal, oral, or anal intercourse with Group 2 partner on at least 12 occasions (St. Mary's cohort) or 25 occasions (MRC/UVRI Uganda cohort) during the 12 months prior to screening; the first sexual exposure with Group 2 partner must have occurred at least 10 months prior to screening
- Inclusion Criteria for Group 2 (St. Mary's cohort):
- HIV-1 infected at screening, as determined by enzyme immunoassay and western blot
- Documentation of HIV-1 infection for at least 12 months prior to screening, as determined by enzyme immunoassay and western blot
- Willing to provide clinical information about HIV-1 RNA and CD4 cell count
- Report unprotected receptive or insertive vaginal, oral, or anal intercourse with Group 1 partner on at least 12 occasions during the 12 months prior to screening; the first sexual exposure with Group 1 partner must have occurred at least 10 months prior to screening
- Inclusion Criteria for Group 2 (MRC/UVRI Uganda cohort):
- HIV-1 infected, as determined by enzyme immunoassay and western blot
- Report unprotected receptive or insertive vaginal, oral, or anal intercourse with Group 1 partner on at least 25 occasions during the 12 months prior to screening; the first sexual exposure with Group 1 partner must have occurred at least 10 months prior to screening
- HIV-1 infected for at least 12 months prior to screening, as determined by one of the following criteria:
- Report a past medical history indicating Herpes zoster infection within the prior 5 years or report a medical history indicating WHO Clinical Staging Criteria for HIV/AIDS of III or IV within the prior 5 years, OR
- CD4 cell count no greater than 450/mm3 for females or no greater than 400/mm3 for males
- Report no prior HIV testing, test HIV-1 seropositive at screening, and meet one of the following criteria:
- Report a past medical history indicating Herpes zoster infection within the prior 5 years or report a past medical history indicating WHO Clinical Staging Criteria for HIV/AIDS of III or IV in the prior 5 years, OR
- CD4 cell count no greater than 450/mm3 for females or no greater than 400/mm3 for males
- Inclusion Criteria for Group 3:
- HIV-1 antibody negative AND nucleic acid test (NAT) or p24 antigen negative
- Test negative for Neisseria gonorrhoeae, syphilis, Chlamydia trachomatis, and trichomoniasis (MRC/UVRI Uganda cohort only)
- Report a monogamous relationship of at least 12 months duration prior to screening
- Exclusion Criteria for Groups 1, 2, and 3:
- Injection drug use in the 5 years prior to screening
- Any condition that, in the opinion of the investigator, would be unsafe or interfere with the study
- Any obligations that may require long absences from the area
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
522 Patients enrolled
Trial Details
Trial ID
NCT00351442
Start Date
February 1 2007
End Date
September 1 2010
Last Update
April 9 2014
Active Locations (3)
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1
Uganda Virus Research Institute, MRC/UVRI Uganda Research Unit on AIDS CHAVI CRS
Entebbe, Uganda
2
King's College Hosp., Caldecot Ctr. CHAVI CRS
London, United Kingdom
3
St. Mary's Hosp. of London, Imperial College School of Medicine, Clinical Trials Ctr. CHAVI CRS
London, United Kingdom