Status:
WITHDRAWN
Three Month Course of Anti-HIV Medications for People Recently Infected With HIV
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Short-term therapy may reduce the amount of HIV in the blood of adults recently infected with HIV. The purpose of this study is to see whether it is better for people to take a short course of anti-HI...
Detailed Description
Limited access to HIV treatment is a major problem in many parts of the world. If a well tolerated anti-HIV regimen with convenient once-daily dosing is effective in reducing viral load in people with...
Eligibility Criteria
Inclusion
- Acute or early HIV infection, as determined by the NIH Acute Infection and Early Disease Research Program (AIEDRP) definition
- Coenrolled in AIEDRP CORE01 trial
- Willing to use acceptable methods of contraception
Exclusion
- Any severe medical illness that, in the opinion of the investigator, will interfere with the ability to adhere to therapy or will result in making therapy too risky for the patient
- Significant psychiatric illness or ongoing substance abuse that, in the opinion of the investigator, will compromise the ability of the patient to follow study procedures safely and consistently
- Hepatitis B or C infection AND liver enzymes of Grade 2 or greater OR evidence or history of severe hepatitis or cirrhosis
- Creatinine clearance less than 50 ml/min
- Received more than one month of prior antiretroviral therapy. Women who received short-term dosing of nevirapine to prevent mother-to-child transmission during childbirth are not excluded if they meet other study requirements. They should only be given nevirapine as part of an initial study regimen if resistance testing can be done to confirm that they do not have nevirapine resistance.
- Coenrolled in any other HIV treatment or investigational drug trial
- Pregnant or breastfeeding
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00087464
Last Update
November 1 2021
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