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Home > "A" Clinical Trials Conditions > A Study to Monitor Patients with Primary or Early HIV Infection  A Study to Monitor Patients with Primary or Early HIV Infection
A Study to Monitor Patients with Primary or Early HIV Infection
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to monitor patients who recently have been infected with HIV in order to learn how their immune systems respond to HIV infection and to study how the virus acts in their bodies. Primary HIV infection occurs within 20 days to 8 weeks following exposure to HIV. The symptoms of primary HIV infection are usually fever, tiredness, headache, or muscle aches. However, symptoms vary greatly from person to person, and some people might not experience any symptoms at all. Because these symptoms also resemble the cold or the flu, it is difficult to identify patients with primary HIV infection. Information gathered from this study will help doctors decide what kind of treatment is best to give patients who recently have been infected.
Details: Primary HIV-1 infection is frequently identified as a nonspecific viral syndrome occurring within 20 days to 8 weeks following a documented HIV exposure. However, symptoms vary from person to person, and some people undergo asymptomatic seroconversion. Because of the difficulty identifying patients with either acute HIV infection (within 30 days of initial infection) or early infection (within 12 months of initial infection), no systematic review of viral dynamics or immunodynamics in this patient population has been undertaken. A better understanding of the virologic and immunologic parameters during acute and early HIV infection should provide information relevant to the optimal design of future clinical therapeutic trials. The only patient intervention is obtaining blood, lymph node tissue, CSF, and semen or vaginal secretion specimens at designated intervals according to the schedule of evaluations. Patients are followed for 5 years. Patients may elect to start or discontinue antiretroviral therapy at any time; however, no antiretroviral therapy is administered as part of this study. Descriptive analysis includes tolerance and toxicity, magnitude and durability of RNA suppression, magnitude and durability of immunologic responses (CD4 and CD8 cells), and decay and emergence of resistant virus in tissue reservoirs (CSF, genital secretions, and lymph nodes).
Eligibility:
Study Type: Observational, Natural History, Longitudinal
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are at least 13 years old (consent of parent or guardian required if under 18). - Have acute or early HIV infection. The stage of HIV infection will depend on the results of certain lab tests.
Total Enrollment: 100
Location and Contact Information:
Overall Study Official:
SusanLittle, Principal Investigator,
UCSD *Recruiting*
San Diego, California, 92103
United States
Recruiting Susan Little 619-543-8080
Additional Information:
Study ID Numbers: AIEDRP AI-05-001; SD AEHIV 001,AEHIV 001
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000911
Other Hiv Infections Studies:
1. Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
2. Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients with AIDS Who Have CMV Retinitis
3. A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
4. A Study to Evaluate the Effects of Giving IL-2 Alone to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3 Who Do Not Wish to Receive Anti-HIV Therapy
5. Aerosols in the Treatment of Asymptomatic Pneumocystis Pneumonia: A Pilot Study Assessing the Effectiveness of Aerosolized Pentamidine as Treatment of Subclinical Pneumocystis Infection in Patients With No Clinical Symptoms
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A Study to Monitor Patients with Primary or Early HIV Infection
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