Effectiveness of Antiretroviral Therapy During Acute HIV Infection

• Status: Completed
• Trial end date: 2017-07-16
• Target enrollment: 0
• Participant gender: All

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 increasing the amount of CD4 cells in the blood of people with HIV, compared to the amounts of HIV and CD4 cells in people who do not receive treatment at this stage.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Anti-Retroviral Agents

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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