Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Emtricitabine/ tenofovir disoproxil fumarate; Lopinavir/Ritonavir
Intervention description: once daily; twice daily
Intervention MeSH terms: Ritonavir; Lopinavir; Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Infection; Treatment Naive

Summary:

      Although some doctors favor starting anti-HIV treatment as soon as possible after patients
      learn they are infected, it is not known if treatment for recently infected patients results
      in long-term benefits or harm. The purpose of this study is to learn whether or not people
      should take anti-HIV drugs when they are first infected.
    

Eligibility criteria:

        Inclusion Criteria for Step 1:

          -  Recently infected with HIV

          -  No prior antiretroviral therapy (ART)

          -  CD4 count of 350 cells/mm3 or more AND a CD4% of 14% or more within 21 days prior to
             study entry

          -  HIV viral load of 500 copies/ml or more within 21 days prior to study entry

          -  Required laboratory values obtained within 21 days prior to study entry

          -  18 years or older

          -  Ability and willingness to provide written informed consent

          -  Willing to use acceptable forms of contraception

        Exclusion Criteria for Step 1:

          -  HIV progression to CDC category B or C disease

          -  Pregnancy or breastfeeding

          -  History of pancreatitis or coronary artery disease

          -  Prior ART. Participants who took antiretrovirals for postexposure prophylaxis more
             than one year prior to study entry are not excluded.

          -  Certain medications within 21 days prior to study entry. Participants who agree to
             receive an alternative ART regimen approved by the investigator will not be excluded.

          -  Previously received an investigational anti-HIV vaccine

          -  Current therapy with systemic corticosteroids. Patients who are taking a short course
             (less than 21 days) of corticosteroids are not excluded.

          -  Current therapy with systemic chemotherapeutic agents; nephrotoxic systemic agents;
             immunomodulatory treatments, including interleukin-2; or investigational agents

          -  Known allergy or sensitivity to study drugs or their formulations

          -  Current alcohol or drug use that, in the opinion of the investigator, would interfere
             with the study

          -  Serious medical or psychiatric illness that, in the opinion of the investigator, would
             interfere with the study

          -  Hepatitis B surface antigen positive within 21 days prior to study entry

          -  Known resistance to one or more components of the study drug regimen

        Inclusion Criteria for Step 2:

          -  subjects in DT arm who meet one of the following five criteria will be advised to
             enter step 2 and initiate ART:

               1. CD4 cell counts below 350 cells/mm3 on 2 consecutive determinations at least 4
                  weeks apart at or after the step 1, week 12 study visit

               2. HIV-1 RNA above 750,000 copies/mL confirmed on 2 consecutive determinations at
                  least 1 week apart at or after the step 1, week 4 study visit

               3. HIV-1 RNA above 200,000 copies/mL on 2 consecutive determinations at least 1 week
                  apart at or after the step 1, week 12 study visit

               4. Clinical progression to CDC category B or C disease

               5. CD4 count below 200 cells/mm3 or CD4 percent less than 14% at any time on study

          -  subjects in IT arm who meet one of the following five criteria after discontinuing
             study medications will be advised to enter step 2 and re-initiate ART:

               1. CD4 cell counts below 350 cells/mm3 on 2 consecutive determinations at least 4
                  weeks apart at or after the step 1, week 12 post-treatment- discontinuation study
                  visit

               2. HIV-1 RNA above 750,000 copies/mL confirmed on 2 consecutive determinations at
                  least 1 week apart at or after the step 1, week 4 post-treatment- discontinuation
                  study visit

               3. HIV-1 RNA above 200,000 copies/mL on 2 consecutive determinations at least 1 week
                  apart at or after the step 1, week 12 post-treatment- discontinuation study visit

               4. Clinical progression to CDC category B or C disease

               5. CD4 count below 200 cells/mm3 or CD4 percent less than 14% at any time on study

                  Exclusion Criteria for Step 2:

          -  Pregnancy or breastfeeding

        Inclusion Criteria for Step 3:

          -  Study participants who were on Step 1, IT arm and had completed or ended prematurely
             the 36 week course of early ART and did not on ART either because they did not meet
             eligibility criteria for Step 2 or because they did not start ART even after meeting
             the Step 2 eligibility criteria.

          -  Study participants on Step 1, DT arm who were not on ART either because they did not
             meet eligibility criteria for Step 2 or because they did not start ART even after
             meeting the Step 2 eligibility criteria.

          -  Previous A5217 participants who had either completed the study or ended prematurely
             their participation in the study, AND were not on ART either because they never met
             eligibility criteria for Step 2 or because they had not started ART even after meeting
             the Step 2 eligibility criteria.

          -  All A5217 participants who were on Step 1 and in the midst of their 36 weeks of
             randomized ART and who completed a portion or all of the 36 weeks of originally
             recommended therapy, AND chose then to interrupt their ART.

        Exclusion Criteria for Step 3:

          -  Participants who were on Step 1, IT arm of the study receiving ART.

          -  Participants in Step 2 or who had otherwise initiated long-term ART, regardless of
             whether they were on treatment.