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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00055120 |
The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI.
Condition | Intervention | Phase |
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HIV Infections AIDS-Related Opportunistic Infections |
Drug: Emtricitabine/tenofovir disoproxil fumarate Drug: Lopinavir/ritonavir Drug: Stavudine |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase IV Study of Antiretroviral Therapy for HIV Infected Adults Presenting With Acute Opportunistic Infections: Immediate Versus Deferred Initiation of Antiretroviral Therapy |
Estimated Enrollment: | 282 |
Study Start Date: | May 2003 |
Study Completion Date: | August 2007 |
Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Despite the advent of highly active antiretroviral therapy (HAART), many HIV infected patients without access to antiretroviral therapy (ART) present with acute OIs. Such presentations pose a management problem, as there are currently no data available as to whether initiating HAART during the acute presentation is of benefit. Reports of an immune reconstitution inflammatory syndrome (IRIS) marked by increasing hypoxia or new pulmonary infiltrates have been associated with the initiation of ART in patients with AIDS. There is also concern as to drug interactions between ART and antimicrobials used to treat the presenting OI. This study will evaluate the possible benefits and costs of initiating ART in HIV infected patients who present with an AIDS-defining OI.
There are 2 steps in this study. In Step 1, patients will be randomly assigned to one of two study arms. Arm A will receive ART within 2 weeks of starting therapy for the acute OI. Arm B will have ART deferred until Step 2, at least 4 weeks and no more than 32 weeks after beginning therapy for the acute OI. Only Arm B participants will enter Step 2, which will likely begin between Weeks 6 and 12. The study will make the following drugs available for construction of an antiretroviral (ARV) regimen: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), lopinavir/ritonavir (LPV/RTV), and stavudine (d4T). Use of other ARV drugs is at the discretion of the study official. Drug regimen additions and substitutions will be made on a case-by-case basis.
Patients will be followed for 48 weeks and will have 10 study visits. All study visits will include a physical exam, medication history, and blood collection. Patients will be asked to complete questionnaires assessing health status and adherence at selected visits.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Note: Participants who enrolled in this study prior to Version 3.0 will be offered and allowed to switch to FTC/TDF if they wish. However, participants under the age of 18 cannot receive FTC/TDF through this study.
Inclusion Criteria for Step 1:
Exclusion Criteria for Step 1:
Study Chair: | Andrew R. Zolopa, MD | Division of Infectious Diseases, Stanford University |
Study ID Numbers: | ACTG A5164 |
Study First Received: | February 19, 2003 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00055120 |
Health Authority: | United States: Federal Government |
Anti-HIV Agents Disease Progression Drug Administration Schedule Viral Load |
HIV-1 Treatment Outcome Survival Analysis Treatment Naive |
Opportunistic Infections Sexually Transmitted Diseases, Viral Stavudine Acquired Immunodeficiency Syndrome Disease Progression Immunologic Deficiency Syndromes Virus Diseases Lopinavir Emtricitabine |
Ritonavir HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Tenofovir Parasitic Diseases Retroviridae Infections Tenofovir disoproxil |
Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |