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Home > "A" Clinical Trials Conditions > A Study to Monitor the Health of Participants in HIVNET 014 Who Become Infected with HIV-1  A Study to Monitor the Health of Participants in HIVNET 014 Who Become Infected with HIV-1
A Study to Monitor the Health of Participants in HIVNET 014 Who Become Infected with HIV-1
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to evaluate the long-term consequences of HIV-1 infections that occurred in association with known, but discouraged, high-risk behaviors in persons who have received HIV candidate vaccines or placebo in HIVNET 014. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS. Patients who receive HIV vaccines are sometimes protected from HIV infection. More often, these patients become HIV-positive but experience a boost in their immune system that helps their bodies fight HIV. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS.
Details: There are many possible outcomes of HIV-1 infection among persons who receive experimental HIV-1 vaccines. In the best-case scenario, these vaccines may prevent infection (sterilizing immunity). However, current viral vaccines are thought to limit, but not prevent, virus replication after infection. In the latter case, it is important to document the effect of the immune response on the disease course as reflected by viral load, the evolution of the viral quasi species, and clinical symptoms over time. Understanding the evolution of the immune response in vaccinees after subsequent exposure and HIV infection will potentially result in valuable information for the subsequent design of preventive and therapeutic vaccines. This will be studied here using HIVNET 014 participants at higher risk for HIV-1 infection. Participants discontinue HIVNET 014 vaccinations upon confirmation of HIV-1 infection and are enrolled in this study. Participants undergo clinical and laboratory examinations every 3 months for the first year of follow-up and every 6 months for at least 4 years thereafter. Additionally, HIV-infected partners of HIVNET 014A participants undergo clinical and laboratory examination at enrollment, and may be asked to donate additional specimens at a later time. Study endpoints include various virologic, immunologic, and clinical parameters, such as viral load, cellular immune response, and virus phenotype and genotype.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Become infected with HIV while participating in HIVNET 014, or if they are an HIV-positive partner (sexual or needle-sharing) of a HIVNET 014A participant. - Are able and willing to provide written informed consent. Exclusion Criteria Patients will not be eligible for this study if they: - Have a serious psychiatric or psychological disorder that would prevent them from completing the study.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ConnieCelum, Study Chair,
New York Univ Med Ctr
New York City, New York, 10016
United States
Fenway Community Health Ctr / HIVNET
Boston, Massachusetts, 02115
United States
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, 94102
United States
Howard Brown Health Ctr / HIVNET
Chicago, Illinois, 60657
United States
Univ of Illinois Chicago / Howard Brown Hlth Ctr
Chicago, Illinois, 60612
United States
Denver Dept of Public Health / HIVNET
Denver, Colorado, 80204
United States
Miriam Hosp
Providence, Rhode Island, 02906
United States
Univ of Pennsylvania / HIVNET
Philadelphia, Pennsylvania, 19104
United States
Univ of Washington
Seattle, Washington, 98104
United States
New York Blood Ctr
Bronx, New York, 10456
United States
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860
United States
Additional Information:
Study ID Numbers: HIVNET 014A;
Study Start Date: August 1999
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001121
Other Hiv Infections Studies:
1. Tolerability of Three Local Anesthetic Formulations in Conjunction with NGX-4010 for the Treatment of Neuropathic Pain
2. Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting
3. Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients with AIDS or Advanced ARC
4. A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
5. Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals
Related Studies:
Other HIV Infections Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
A Study to Monitor the Health of Participants in HIVNET 014 Who Become Infected with HIV-1
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