Outcomes of Anti-HIV Therapy During Early HIV Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001093
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : October 29, 2012
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

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 or disease
HIV Infections

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.

Study Type : Observational
Enrollment : 48 participants
Official Title: Outcomes of Antiretroviral Therapy During Primary HIV Infection
Study Start Date : October 1999
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00001093

United States, California
Cedars Sinai Med Ctr
Los Angeles, California, United States, 90048
San Diego, California, United States, 92103
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, United States, 94110
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Susan Little
Principal Investigator: James Kahn
Principal Investigator: Eric Daar Identifier: NCT00001093     History of Changes
Other Study ID Numbers: AI-05-005
AIEDRP AI-05-005
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: October 29, 2012
Last Verified: October 2012

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

Additional relevant MeSH terms:
Communicable Diseases
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