A Study of HIV in Newly Infected Individuals
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Purpose
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.
| Condition |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Infected Participants Protocol: Evaluation of Natural History of HIV Infection in Newly HIV-Infected Persons in HIVNET Target Populations |
- Detection of changes in HIV phenotype and genotype [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Clinical progression rates [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Antiviral resistance [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Specimens appropriate for clinical and laboratory assessments and necessary for evaluation of study outcome measures
| Groups/Cohorts |
|---|
|
A
HIV-infected individuals enrolled in HIVNET D01
|
|
B
Individuals with newly acquired HIV infection
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Contacts and Locations| United States, California | |
| Los Angeles County / Health Research Assoc / Drew Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| San Francisco Dept of Hlth / AIDS Office | |
| San Francisco, California, United States, 94102 | |
| United States, Colorado | |
| Denver Dept of Public Health / HIVNET | |
| Denver, Colorado, United States, 80204 | |
| United States, Illinois | |
| Univ of Illinois Chicago / Howard Brown Hlth Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| Johns Hopkins Univ | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| Fenway Community Health Ctr / HIVNET | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| New York Blood Ctr | |
| Bronx, New York, United States, 10456 | |
| Bronx-Lebanon Hosp Ctr | |
| Bronx, New York, United States, 10453 | |
| New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania / HIVNET | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Miriam Hosp | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 98104 | |
| Study Chair: | Celum C | |
| Study Chair: | Buchbinder S | |
| Study Chair: | Sheppard H |
More Information
No publications provided
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000930 History of Changes |
| Other Study ID Numbers: | HIVNET 019 |
| Study First Received: | November 2, 1999 |
| Last Updated: | October 29, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Sexual Partners Drug Resistance, Microbial Cohort Studies Risk Factors Substance Abuse, Intravenous |
Disease Progression Homosexuality, Male Genotype Phenotype |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 22, 2013