Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acute Infection, Early HIV Infection, Short-Term Antiretroviral Therapy, Treatment Interruption, Antiretroviral Drug (ARV), ART
Eligibility 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
Sites / Locations
- University of Colorado Health Sciences Center
- AIDS Research Consortium of Atlanta
- University of Zimbabwe College of Health Sciences
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Treatment interruption
CD4 T cell guided therapy
Oral Tenofovir disoproxil fumarate/Emtricitabine and Lopinavir/Ritonavir for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
Anti Retroviral Therapy initiated when AIDS-defining illness occurs or if CD4 count is confirmed at less than 350 mm^3 at two separate, consecutive measurements