- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00000930
A Study of HIV in Newly Infected Individuals
Infected Participants Protocol: Evaluation of Natural History of HIV Infection in Newly HIV-Infected Persons in HIVNET Target Populations
The purpose of this study is to see how HIV reacts in the immune systems of patients who have recently been infected with HIV. This study also examines HIV's resistance to anti-HIV drugs in newly infected patients.
Certain populations are good candidates for participation in HIV vaccine trials. These groups include men who have sex with men, IV drug users, and women at risk of getting HIV through heterosexual contact. Learning how HIV behaves in these populations once they become infected can help with the planning of future HIV vaccine studies.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This study provides an opportunity to prospectively monitor markers of HIV infection and disease progression in cohorts suitable for HIV vaccine trials. The detection of changes in HIV phenotype and genotype, clinical progression rates, and antiretroviral resistance within study populations over time are important for planning future HIV vaccine trials.
This study consists of two parts. Part A includes HIV-infected patients who enrolled in HIVNET D01.1 (infected-participants cohort of HIVNET D01) and whose HIV disease has been closely monitored and characterized. This study continues to monitor these patients with follow-up evaluations every 3 months for the first 18 months and then every 6 months thereafter. Part B includes newly HIV-infected patients. These patients are monitored with clinical and laboratory evaluations at 0, 1, 3, 6, 9, 12, and 18 months, and then every 6 months through Year 5.
Undersøgelsestype
Kontakter og lokationer
Studiesteder
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California
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Los Angeles, California, Forenede Stater, 90033
- Los Angeles County / Health Research Assoc / Drew Med Ctr
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San Francisco, California, Forenede Stater, 94102
- San Francisco Dept of Hlth / AIDS Office
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Colorado
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Denver, Colorado, Forenede Stater, 80204
- Denver Dept of Public Health / HIVNET
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Univ of Illinois Chicago / Howard Brown Hlth Ctr
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Maryland
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Baltimore, Maryland, Forenede Stater, 21205
- Johns Hopkins Univ
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Fenway Community Health Ctr / HIVNET
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New York
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Bronx, New York, Forenede Stater, 10453
- Bronx-Lebanon Hosp Ctr
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Bronx, New York, Forenede Stater, 10456
- New York Blood Ctr
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New York, New York, Forenede Stater, 10016
- New York Univ Med Ctr
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Univ of Pennsylvania / HIVNET
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02906
- Miriam Hosp
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Washington
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Seattle, Washington, Forenede Stater, 98104
- Univ of Washington
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Beskrivelse
Inclusion Criteria
Patients must have:
- HIV infection, as documented by enrollment in HIVNET D01.1 (Part A patients) or by standard HIV serological tests or demonstrated HIV infection on virologic assay (Part B patients).
Part A only:
- Previous enrollment in infected-participants cohort of HIVNET D01.
Part B only:
- Initial HIV-seronegativity on an HIVNET protocol (other than an HIV vaccine protocol) and testing positive for HIV at a subsequent clinic visit.
- Confirmation of HIV infection and documentation of HIV negative antibody test within 8 months of first positive test.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions are excluded:
- An obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the study.
Prior Medication:
Excluded:
- Participation in a HIVNET HIV vaccine trial.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
A
HIV-infected individuals enrolled in HIVNET D01
|
B
Individuals with newly acquired HIV infection
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Detection of changes in HIV phenotype and genotype
Tidsramme: Throughout study
|
Throughout study
|
Clinical progression rates
Tidsramme: Throughout study
|
Throughout study
|
Antiviral resistance
Tidsramme: Throughout study
|
Throughout study
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Celum C
- Studiestol: Buchbinder S
- Studiestol: Sheppard H
Datoer for undersøgelser
Studer store datoer
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- RNA-virusinfektioner
- Virussygdomme
- Blodbårne infektioner
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Sygdomme i immunsystemet
- Langsomme virussygdomme
- HIV-infektioner
- Infektioner
- Erhvervet immundefektsyndrom
Andre undersøgelses-id-numre
- HIVNET 019
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