NCT00351442

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 infection. The purpose of this study is to analyze the immune system responses of individuals who are exposed to HIV-1 but remain uninfected.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
522

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Typical duration for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

April 9, 2014

Status Verified

April 1, 2014

Enrollment Period

3.6 years

First QC Date

July 11, 2006

Last Update Submit

April 8, 2014

Conditions

HIV Infections

Keywords

Host Resistance

Study Arms (3)

1

Inidividuals who have been exposed to HIV but remain uninfected.

2

HIV infected regular sexual partners of Group 1 participants.

3

HIV uninfected individuals or couples who have not been exposed to HIV.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample, including HIV infected individuals and their uninfected partners.

You may qualify if:

  • Willing to provide adequate location information
  • Planning to remain in the area for the duration of the study
  • 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
  • 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
  • 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
  • +4 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Uganda Virus Research Institute, MRC/UVRI Uganda Research Unit on AIDS CHAVI CRS

Entebbe, Uganda

Location

King's College Hosp., Caldecot Ctr. CHAVI CRS

London, United Kingdom

Location

St. Mary's Hosp. of London, Imperial College School of Medicine, Clinical Trials Ctr. CHAVI CRS

London, United Kingdom

Location

Related Publications (5)

  • An P, Bleiber G, Duggal P, Nelson G, May M, Mangeat B, Alobwede I, Trono D, Vlahov D, Donfield S, Goedert JJ, Phair J, Buchbinder S, O'Brien SJ, Telenti A, Winkler CA. APOBEC3G genetic variants and their influence on the progression to AIDS. J Virol. 2004 Oct;78(20):11070-6. doi: 10.1128/JVI.78.20.11070-11076.2004.

    PMID: 15452227BACKGROUND

  • Kebba A, Kaleebu P, Rowland S, Ingram R, Whitworth J, Imami N, Gotch F. Distinct patterns of peripheral HIV-1-specific interferon- gamma responses in exposed HIV-1-seronegative individuals. J Infect Dis. 2004 May 1;189(9):1705-13. doi: 10.1086/383227. Epub 2004 Apr 19.

    PMID: 15116309BACKGROUND

  • Kebba A, Kaleebu P, Serwanga J, Rowland S, Yirrell D, Downing R, Gilmour J, Imami N, Gotch F, Whitworth J. HIV type 1 antigen-responsive CD4+ T-lymphocytes in exposed yet HIV Type 1 seronegative Ugandans. AIDS Res Hum Retroviruses. 2004 Jan;20(1):67-75. doi: 10.1089/088922204322749512.

    PMID: 15000700BACKGROUND

  • Missale G, Papagno L, Penna A, Pilli M, Zerbini A, Vitali P, Pieroni G, Urbani S, Uggeri J, Pinheiro S, Rowland-Jones S, Ferrari C. Parenteral exposure to high HIV viremia leads to virus-specific T cell priming without evidence of infection. Eur J Immunol. 2004 Nov;34(11):3208-15. doi: 10.1002/eji.200424889.

    PMID: 15459901BACKGROUND

  • O'Brien SJ, Nelson GW. Human genes that limit AIDS. Nat Genet. 2004 Jun;36(6):565-74. doi: 10.1038/ng1369.

    PMID: 15167933BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Andrew J. McMichael, MD, PhD

    University of Oxford, Weatherall Institute of Molecular Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 12, 2006

Study Start

February 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

April 9, 2014

Record last verified: 2014-04

Locations

UG(1)GB(2)