Clinical trial NCT00000930: A Study of HIV in Newly Infected Individuals
Official title: Infected Participants Protocol: Evaluation of Natural History of HIV Infection in Newly HIV-Infected Persons in HIVNET Target Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Sexual Partners
Drug Resistance, Microbial
Cohort Studies
Risk Factors
Substance Abuse, Intravenous
Disease Progression
Homosexuality, Male
Genotype
Phenotype
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Detection of changes in HIV phenotype and genotype
timeFrame: Throughout study
measure: Clinical progression rates
timeFrame: Throughout study
measure: Antiviral resistance
timeFrame: Throughout study
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County / Health Research Assoc / Drew Med Ctr
state: California
city: San Francisco
country: United States
facility: San Francisco Dept of Hlth / AIDS Office
state: California
city: Denver
country: United States
facility: Denver Dept of Public Health / HIVNET
state: Colorado
city: Chicago
country: United States
facility: Univ of Illinois Chicago / Howard Brown Hlth Ctr
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Univ
state: Maryland
city: Boston
country: United States
facility: Fenway Community Health Ctr / HIVNET
state: Massachusetts
city: Bronx
country: United States
facility: Bronx-Lebanon Hosp Ctr
state: New York
city: Bronx
country: United States
facility: New York Blood Ctr
state: New York
city: New York
country: United States
facility: New York Univ Med Ctr
state: New York
city: Philadelphia
country: United States
facility: Univ of Pennsylvania / HIVNET
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hosp
state: Rhode Island
city: Seattle
country: United States
facility: Univ of Washington
state: Washington
Study officials:
name: Celum C
role: STUDY_CHAIR
name: Buchbinder S
role: STUDY_CHAIR
name: Sheppard H
role: STUDY_CHAIR
References: