Anti-HIV Medications for People Recently Infected With HIV - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00106171

Purpose

It is not known if anti-HIV treatment for recently infected patients improves long-term patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV medications slows progression of HIV disease in adults recently infected with HIV.

Study hypothesis: A one-year course of HAART administered during acute or early seroconversion may slow the progression of HIV infection.

Condition	Intervention	Phase
HIV Infections	Drug: Highly active antiretroviral therapy (HAART)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Trial of HAART in Acute/Early HIV Infection

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

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

Primary Outcome Measures:

Comparison of the plasma viral load in all treated vs. untreated patients [ Time Frame: At Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of the plasma viral load in all treated vs. untreated patients [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
Comparison of the CD4 lymphocyte count in all treated vs. untreated patients [ Time Frame: At Months 24 and 36 ] [ Designated as safety issue: No ]
Comparison of the plasma viral load in patients treated in the acute vs. early stage of infection [ Time Frame: At Months 24 and 36 ] [ Designated as safety issue: No ]
Comparison of the CD4 lymphocyte count in patients treated in the acute vs. early stage of infection [ Time Frame: At Months 24 and 36 ] [ Designated as safety issue: No ]
Toxicity of HAART in all treated patients [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	180
Study Start Date:	February 2005
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive HAART for 1 year	Drug: Highly active antiretroviral therapy (HAART) Regimens will be assigned by investigators
2: No Intervention Participants will receive no treatment

Detailed Description:

Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in slower progression of HIV disease. This study will compare the virologic outcomes of recently infected adults who receive highly active antiretroviral therapy (HAART) with those who receive no treatment. This study will also compare the effects of treatment on patients who enroll within 3 months of seroconversion (acute seroconverters) with patients who enroll within 3 to 12 months of seroconversion (early seroconverters).

This study will last at least 3 years. Participants will be randomly assigned to one of two groups. Group 1 will receive HAART for 1 year; Group 2 will receive no treatment. There will be at least 20 study visits over the 3-year study period. Blood collection will occur at all study visits. A physical exam, medical and medication history, and risk behavior assessment will occur at most visits; participants will also be asked to complete an adherence questionnaire at most visits.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented acute or recent HIV infection (infected in the past 12 months) as defined in the study protocol
Antiretroviral naive. Participants who have taken antiretrovirals for postexposure prophylaxis are eligible for this study.
Able to swallow tablets or capsules
Willing to use acceptable forms of contraception

Exclusion Criteria:

Physician unable to design a potentially effective HAART regimen based on results of genotypic resistance testing
Two CD4 counts of less than 350 cells/mm3 obtained at least 7 days apart within 30 days of study entry
Viral load less than 5,000 copies/ml within 30 days of study entry in participants who have been infected with HIV-1 for more than six months prior to study entry
Use of systemic cancer chemotherapy, systemic investigational agents, specific antiretroviral medications, or immunomodulators (growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons) within 30 days prior to study entry
Current alcohol or drug use that, in the opinion of the investigator, would interfere with the study
Serious illness requiring systemic treatment or hospitalization until participant either completes therapy or is clinically stable on therapy for at least 7 days prior to study entry
Currently involuntarily incarcerated for treatment of either a psychiatric or physical (e.g., infectious disease) illness
Pregnancy or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106171

Locations

United States, Maryland
Johns Hopkins University	Recruiting
Baltimore, Maryland, United States, 21205
Contact: Linda G. Apuzzo, BS/CCRC 410-614-7796 lapuzzo@jhsph.edu
Principal Investigator: Joseph B. Margolick, MD, PhD
Canada, British Columbia
University of British Columbia	Recruiting
Vancouver, British Columbia, Canada, V6Z2C7
Contact: Jennie Prasad, MS 604-642-6429 jenniepd@interchange.ubc.ca
Principal Investigator: Brian Conway, MD, FRCPC
Canada, Ontario
Sunnybrook Health Sciences Ctr.	Recruiting
Toronto, Ontario, Canada, M4N 3M5 CA
Contact: Miriam Bast 416-480-5900 mriam.bast@ssunnybrook.ca
Principal Investigator: Anita Rachlis, MD
Canadian Immunodeficiency Research Collaborative (CIRC) Inc.	Recruiting
Toronto, Ontario, Canada, M5B IL6
Contact: Mona Loutify, MD (416) 465-7936 loutify@schospital.ca
Principal Investigator: Colin Kovacs, MD
Canada, Quebec
CHUM - Hotel-Dieu	Recruiting
Montreal, Quebec, Canada, H2W 1T8 CA
Contact: Genevieve Bujold 514-890-9000 genevieve.bujold.chum@ssss.gouv.qc.ca
Principal Investigator: Cecile Tremblay, MD

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

Joseph B. Margolick, MD, PhD

Johns Hopkins University

More Information

Additional Information:

Click here for more information about starting anti-HIV medications This link exits the ClinicalTrials.gov site

Publications:

Smith DE, Walker BD, Cooper DA, Rosenberg ES, Kaldor JM. Is antiretroviral treatment of primary HIV infection clinically justified on the basis of current evidence? AIDS. 2004 Mar 26;18(5):709-18. Review. No abstract available.

Responsible Party:	Johns Hopkins University ( Joseph B. Margolick, MD, PhD )
Study ID Numbers:	1R01AI056990-01A1, 1R01-AI056990-01A1
Study First Received:	March 21, 2005
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00106171 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

HIV
Acute/Early Seroconverters
Acute Infection
Treatment Naive
Primary HIV Infection

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on March 18, 2010