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Outcomes of Anti-HIV Therapy During Early HIV Infection
This study is ongoing, but not recruiting participants.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001093
  Purpose

The purpose of this study is to find out if it is effective to give aggressive anti-HIV therapy to patients who have been infected recently with HIV.

Many doctors recommend that patients who have recently been infected with HIV begin anti-HIV treatment as soon as possible. However, early HIV infection is not yet completely understood, so it is not known if this is the best approach. This study will look at the effects of beginning anti-HIV treatment during early HIV infection.


Condition
HIV Infections

MedlinePlus related topics: AIDS
U.S. FDA Resources
Study Type: Observational
Official Title: Outcomes of Antiretroviral Therapy During Primary HIV Infection

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

Estimated Enrollment: 48
Detailed Description:

Although many researchers have recommended initiation of aggressive antiretroviral therapy as soon as possible after HIV infection occurs, the tolerability and efficacy of this approach has not been systemically evaluated. Many features of primary HIV pathogenesis are incompletely understood. A more complete understanding of immune dynamics and viral pathogenesis during primary HIV infection is critical to determine optimal treatment intervention strategies. This study will evaluate the outcomes of potent antiretroviral therapy initiated at different stages of primary HIV infection.

Thirty-six of the study patients are coenrolled to ACTG 371 or another treatment protocol. All study drug treatment and toxicity management is performed according to guidelines in these treatment protocols. An untreated cohort of 12 patients is also followed on this study. Patients are stratified at enrollment according to their stage of acute or early HIV infection. Patients are evaluated for virologic, immunologic, and clinical parameters for 96 weeks. In addition, novel studies of source partner identification are proposed. An effort is made to determine the most likely source partner(s) for each study patient on the basis of patient recall of possible exposures. A separate study protocol will evaluate the source partner.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are at least 13 years old.
  • Have acute or early HIV infection. The stage of HIV infection will depend on the results from certain lab tests.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Are pregnant or breast-feeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001093

Locations
United States, California
UCSD
San Diego, California, United States, 92103
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, United States, 94110
Cedars Sinai Med Ctr
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Investigators
Principal Investigator: Susan Little
Principal Investigator: James Kahn
Principal Investigator: Eric Daar
  More Information

Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site

Study ID Numbers: AIEDRP AI-05-005, AEHIV 005
Study First Received: November 2, 1999
Last Updated: August 6, 2008
ClinicalTrials.gov Identifier: NCT00001093  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Immunity, Cellular
Sexual Partners
Treatment Outcome
Anti-HIV Agents
Viral Load
Acute Infection

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009