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Home > "A" Clinical Trials Conditions > A Study of HIV in Newly Infected Individuals  A Study of HIV in Newly Infected Individuals
A Study of HIV in Newly Infected Individuals
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CelumC, Study Chair,
New York Blood Ctr
Bronx, New York, 10456
United States
Univ of Pennsylvania / HIVNET
Philadelphia, Pennsylvania, 19104
United States
New York Univ Med Ctr
New York City, New York, 10016
United States
Johns Hopkins Univ
Baltimore, Maryland, 21205
United States
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, California, 90033
United States
Denver Dept of Public Health / HIVNET
Denver, Colorado, 80204
United States
Fenway Community Health Ctr / HIVNET
Boston, Massachusetts, 02115
United States
Miriam Hosp
Providence, Rhode Island, 02906
United States
Bronx-Lebanon Hosp Ctr
Bronx, New York, 10453
United States
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, 94102
United States
Univ of Washington
Seattle, Washington, 98104
United States
Univ of Illinois Chicago / Howard Brown Hlth Ctr
Chicago, Illinois, 60612
United States
Additional Information:
Study ID Numbers: HIVNET 019;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000930
Other Hiv Infections Studies:
1. Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis
2. The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients
3. A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women
4. Quality of Life in Children with HIV Infection
5. A Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
A Study of HIV in Newly Infected Individuals
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