Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and effectiveness of an anti-HIV drug regimen followed by treatment interruption in people recently infected with HIV. This study will also compare the effects of a treatment regimen including treatment interruption with a treatment plan based on clinical indicators.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Emtricitabine; Lopinavir; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• Acute or recent HIV-1 infection. More information about this criterion can be found in the protocol.

• CD4 count 500 cells/mm3 or greater

• No evidence of prior or current AIDS-defining illness

• No signs or symptoms of HIV infection or AIDS-defining illness that, in the opinion of the investigator, requires ART

• Willing to use acceptable forms of contraception

Exclusion Criteria:

• Prior treatment with any antiretroviral drug for more than 7 days

• Use of certain drugs within 21 days of study entry

• Prior receipt of investigational anti-HIV-1 vaccine

• Ongoing therapy with systemic corticosteroids, chemotherapeutic agents, nephrotoxic systemic agents, immunomodulatory treatments, or investigational agents

• Known allergy/sensitivity to study drugs or their formulations

• Current drug or alcohol use or abuse that, in the opinion of the investigator, may interfere with the study

• Serious medical or psychiatric illness that may interfere with the study

• Hepatitis B infected

• Pregnancy or breastfeeding