NCT00006298

Brief Summary

The main goal of this study is to find out how the immune system responds to a specific type of HIV infection, known as C HIV-1, in order to develop a vaccine against this type of infection. The study involves Southern African populations. The HIV-1 virus changes rapidly and many different subtypes have been found. In South Africa, limited data have suggested Subtype C HIV-1 is the most common. This study strives to verify the most common subtype and also look at genetic differences and immune responses among newly infected individuals. Results will aid in the development of vaccines specific for certain geographical areas.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2000

Completed
11 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

September 25, 2008

Status Verified

July 1, 2004

First QC Date

September 26, 2000

Last Update Submit

September 24, 2008

Conditions

Keywords

HIV AntibodiesHIV-1CD4 Lymphocyte CountT-Lymphocytes, CytotoxicGenotypeSpecies SpecificityNeutralization TestsViral LoadAllelesHLA AntigensCross ReactionsImmunodominant EpitopesHaplotypes

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants may be eligible for this study if they:
  • Are first HIV-negative and later test HIV-positive; or are HIV-positive and have evidence of being HIV-negative within the 8 months prior to first testing HIV-positive; or are HIV-positive with one test and HIV-negative with another test.

You may not qualify if:

  • Participants will not be eligible for this study if they:
  • Have a mental disorder that interferes with agreeing to do the study or with participating in the study.
  • Are receiving anti-HIV treatment for more than 4 weeks.
  • Have tuberculosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Missie Allen

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (2)

  • Masemola A, Mashishi T, Khoury G, Mohube P, Mokgotho P, Vardas E, Colvin M, Zijenah L, Katzenstein D, Musonda R, Allen S, Kumwenda N, Taha T, Gray G, McIntyre J, Karim SA, Sheppard HW, Gray CM; HIVNET 028 Study Team. Hierarchical targeting of subtype C human immunodeficiency virus type 1 proteins by CD8+ T cells: correlation with viral load. J Virol. 2004 Apr;78(7):3233-43. doi: 10.1128/jvi.78.7.3233-3243.2004.

  • Masemola AM, Mashishi TN, Khoury G, Bredell H, Paximadis M, Mathebula T, Barkhan D, Puren A, Vardas E, Colvin M, Zijenah L, Katzenstein D, Musonda R, Allen S, Kumwenda N, Taha T, Gray G, McIntyre J, Karim SA, Sheppard HW, Gray CM; HIVNET 028 Study Team. Novel and promiscuous CTL epitopes in conserved regions of Gag targeted by individuals with early subtype C HIV type 1 infection from southern Africa. J Immunol. 2004 Oct 1;173(7):4607-17. doi: 10.4049/jimmunol.173.7.4607.

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

  • Haynes Sheppard

    STUDY CHAIR
  • Desmond Martin

    STUDY CHAIR
  • Clive Gray

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

September 26, 2000

First Posted

August 31, 2001

Last Updated

September 25, 2008

Record last verified: 2004-07

Locations