A Study of Patients Who Recently Have Been Infected With HIV

This study has been withdrawn prior to enrollment.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
First received: October 19, 2000
Last updated: March 5, 2015
Last verified: March 2015

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.

HIV Infections

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

Resource links provided by NLM:

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 0
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00006415     History of Changes
Other Study ID Numbers: AIEDRP AI-08-004  ACRU 010 
Study First Received: October 19, 2000
Last Updated: March 5, 2015
Health Authority: United States: Federal Government

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on May 26, 2016