Tenofovir, Emtricitabine, and Nevirapine for Recently HIV-Infected Subjects: Can Short-Course, Once Daily Therapy Reduce the Viral Load at 12 Months From Estimated Date of Infection?
Data Collection
Infections
Treatment Study
Summary
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 recent or early HIV infection, this regimen could be used globally for controlling HIV. This study will determine the effectiveness of a three-month antiretroviral regimen in reducing viral load in HIV infected adults who were recently infected or have recently seroconverted. This study will recruit participants from Alabama and Tennessee in the United States and in Lusaka, Zambia. Participants in this study must also be enrolled in the AIEDRP CORE01 study. Participants in this study will be divided into Early and Acute groups. Participants in the Early group will be people who have recently seroconverted; participants in the Acute group will be people with primary HIV infection. All participants will choose to receive the once-daily dosing regimen of emtricitabine, nevirapine, and tenofovir disoproxil fumarate. Didanosine, efavirenz, and stavudine may be substituted for other drugs in the regimen at the investigator's discretion. Participants will take the three-drug regimen for 90 days. If a participant's CD4 count is higher than 350 cells/mm3 at Day 90, the participant will stop therapy. If a participant's CD4 count is 350 cells/mm3 or lower at Day 90, or if the participant's CD4 count drops to 350 cells/mm3 or lower while therapy is stopped, the participant will receive an additional 30 days of therapy. This therapy strategy may be repeated as necessary up to Day 180. All participants taking the three-drug regimen will be followed, regardless of whether or not they have taken the regimen beyond Day 90. In addition to AIEDRP CORE01's study visits, 7 additional study visits will occur at pretreatment, on Day 3, and at Weeks 1, 3, 8, 16, and 20. Blood collection will occur at all study visits. Data from study participants will be compared with data from a historical cohort of previously identified HIV infected adults with acute or early infection who did not receive treatment but were followed prospectively.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * 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 Criteria: * 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