Status:
COMPLETED
Effectiveness of Antiretroviral Therapy During Acute HIV Infection
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will determine whether HIV treatment that is initiated during the acute phase of HIV infection, followed by discontinuation of treatment, is effective in reducing the amount of HIV and an i...
Detailed Description
Antiretroviral (ARV) therapy for the treatment of HIV infection has been remarkably successful in reducing morbidity and mortality in HIV infected people. This treatment still has its shortcomings, ho...
Eligibility Criteria
Inclusion
- Acute HIV infection as determined by a positive HIV viral load (at least 5,000 copies of RNA per ml of plasma) and a negative or indeterminate Western Blot test
- Certain laboratory values. More information about this criterion can be found in the protocol.
- Agrees to use an approved form of contraception
Exclusion
- Presence of opportunistic infections or AIDS-defining illnesses, unless they are directly attributable to the acute seroconversion illness
- Receipt of investigational research agents within 30 days prior to study entry
- Receipt of prior experimental HIV vaccines. Individuals who received a saline placebo in a prior HIV vaccine trial are not excluded, provided that they did not receive a sham vector or an adjuvant.
- Receipt of immunosuppressive medications or immunomodulators (e.g., cytokine therapy) within the past 6 months. Participants taking corticosteroid nasal spray for allergic rhinitis; topical corticosteroids for acute, uncomplicated dermatitis; or over the counter medications for acute, uncomplicated dermatitis for a period not longer than 14 days will not be excluded.
- Current use of prohibited concomitant medications
- Current anti-tuberculosis prophylaxis or therapy
- Serious illness other than acute HIV infection requiring systemic treatment or hospitalization until either therapy is completed or patient is clinically stable on therapy
- Hepatitis B surface antigen positivity within 21 days prior to study entry
- Pregnant or breastfeeding
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2017
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00705926
Start Date
October 1 2008
End Date
July 16 2017
Last Update
August 31 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114