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Anti-HIV Medications for People Recently Infected With HIV

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Highly active antiretroviral therapy (HAART)
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, Acute/Early Seroconverters, Acute Infection, Treatment Naive, Primary HIV Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University
  • University of British Columbia
  • Sunnybrook Health Sciences Ctr.
  • Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
  • CHUM - Hotel-Dieu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate Treatment Arm

Deferred Treatment Arm

Arm Description

Participants will receive immediate HAART for 1 year; then HAART will stopped until clinically indicated.

Participants will receive no immediate HAART, but will receive HAART when HAART is clinically indicated.

Outcomes

Primary Outcome Measures

Total Treatment-free Time to Initiation of Permanent HAART
All HAART-free time from initial infection with HIV to initiation of permanent HAART

Secondary Outcome Measures

Toxicity as Assessed by the of Number of Participants With Serious Adverse Events
Number of participants with serious adverse events (grade 3 or 4 as defined by the NIH toxicity scale)

Full Information

First Posted
March 21, 2005
Last Updated
August 22, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00106171
Brief Title
Anti-HIV Medications for People Recently Infected With HIV
Official Title
A Randomized Trial of HAART in Acute/Early HIV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Acute/Early Seroconverters, Acute Infection, Treatment Naive, Primary HIV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Treatment Arm
Arm Type
Experimental
Arm Description
Participants will receive immediate HAART for 1 year; then HAART will stopped until clinically indicated.
Arm Title
Deferred Treatment Arm
Arm Type
No Intervention
Arm Description
Participants will receive no immediate HAART, but will receive HAART when HAART is clinically indicated.
Intervention Type
Drug
Intervention Name(s)
Highly active antiretroviral therapy (HAART)
Intervention Description
Regimens will be assigned by investigators
Primary Outcome Measure Information:
Title
Total Treatment-free Time to Initiation of Permanent HAART
Description
All HAART-free time from initial infection with HIV to initiation of permanent HAART
Time Frame
Through study completion, an average of 18 months
Secondary Outcome Measure Information:
Title
Toxicity as Assessed by the of Number of Participants With Serious Adverse Events
Description
Number of participants with serious adverse events (grade 3 or 4 as defined by the NIH toxicity scale)
Time Frame
Throughout study completion, an average of 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph B. Margolick, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z2C7
Country
Canada
Facility Name
Sunnybrook Health Sciences Ctr.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5 CA
Country
Canada
Facility Name
Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B IL6
Country
Canada
Facility Name
CHUM - Hotel-Dieu
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8 CA
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26600459
Citation
Margolick JB, Apuzzo L, Singer J, Wong H, Lee T, Gallant JE, El-Helou P, Loutfy MR, Rachlis A, Fraser C, Kasper K, Tremblay C, Tossonian H, Conway B. A Randomized Trial of Time-Limited Antiretroviral Therapy in Acute/Early HIV Infection. PLoS One. 2015 Nov 24;10(11):e0143259. doi: 10.1371/journal.pone.0143259. eCollection 2015.
Results Reference
result

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Anti-HIV Medications for People Recently Infected With HIV

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