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A Study of Patients Who Recently Have Been Infected With HIV

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ClinicalTrials.gov Identifier: NCT00006415
Recruitment Status : Withdrawn
First Posted : August 31, 2001
Last Update Posted : March 9, 2015
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

The purpose of this study is to find out if anti-HIV drugs, taken by patients who are newly infected with HIV, can make the level of HIV in the body too low to detect.

Studying patients who recently have been infected with HIV may help researchers understand how HIV infection works and how anti-HIV drugs may help these patients. Approved anti-HIV drugs can reduce the amount of HIV, but more research needs to be done in newly infected patients. This study will look at recently HIV-infected patients to study the progression of HIV disease and to see whether anti-HIV drugs can reduce the level of HIV.

Condition or disease
HIV Infections

Detailed Description:

Primary and early HIV infection represents a potentially unique opportunity to better understand the pathogenesis of HIV infection, as well as to potentially prevent the establishment of latent infection. Approved antiretroviral therapy is able to reduce plasma viremia to unmeasurable levels in established infection and several groups have observed comparable effects in recently infected adults. This study is designed to evaluate and follow a cohort of patients with primary or early HIV infection and to evaluate the time course of latent infection and whether latent infection in CD4 cells will allow viral persistence despite antiretroviral therapy.

Patients begin antiretroviral therapy within 7 days of enrollment. All patients are evaluated for treatment compliance and complete a compliance questionnaire regularly. Clinical evaluations, including CD4, CD8, and HIV RNA counts also are done regularly. Antiretroviral therapy is discontinued if there is no detectable virus by ultrasensitive assay and culture techniques in plasma, PBMCs, and lymphoid tissue. In a subset of patients, genital secretions and CSF (cerebrospinal fluid) are evaluated. If relapse occurs, antiretroviral therapy is re-instituted. In addition, virology and immunology substudies are performed.

Study Type : Observational
Actual Enrollment : 0 participants
Official Title: Evaluation of Subjects With Primary or Early Human Immunodeficiency Virus (HIV) Infection

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Patients may be eligible for this study if they:

  • Have had certain tests indicating that they recently have been infected with HIV.
  • Agree to use effective methods of birth control during the study and for 3 months after.
  • Are at least 18 years old.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have taken anti-HIV drugs.
  • Take erythropoietin, G-CSF or GM-CSF within 30 days of study entry.
  • Take interferons, interleukins, cytotoxic chemotherapy, or HIV vaccines within 30 days of study entry.
  • Take medications that should not be taken with their prescribed anti-HIV drugs.
  • Have had radiation treatment within 30 days of study entry.
  • Are pregnant or breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006415

United States, Pennsylvania
Horsham, Pennsylvania, United States, 19044
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Margaret Fischl
Study Chair: Allan Rodriguez
Study Chair: Ernesto Scerpella

ClinicalTrials.gov Identifier: NCT00006415     History of Changes
Other Study ID Numbers: AIEDRP AI-08-004
ACRU 010
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: March 2015

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Virus Replication
Polymerase Chain Reaction
DNA, Viral
RNA, Viral
Sensitivity and Specificity
Anti-HIV Agents
Viral Load
Acute Infection

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