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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: | NCT00014937 |
ACTG 388 was a clinical trial that compared three- and four-drug anti-HIV drug regimens and demonstrated the effectiveness of a three-drug regimen. This study will compare the ability of two different three-drug anti-HIV drug regimens to reduce levels of HIV in the blood. The study will also evaluate whether patients discontinue the regimens because of drug side effects.
Condition | Intervention |
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HIV Infections |
Drug: lopinavir/ritonavir Drug: lamivudine/zidovudine Drug: efavirenz Drug: lamivudine Drug: stavudine Drug: zidovudine Drug: didanosine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Controlled Trial of Two Potent, Simplified Regimens Utilizing A Protease Inhibitor-Sparing Regimen Versus A Nucleoside-Sparing Regimen for HIV-Infected Subjects Who Participated in ACTG 388 or Who Responded to A First Potent Combination Regimen and Have 200 or Less HIV-1 RNA Copies/ml |
Estimated Enrollment: | 240 |
ACTG 388 was designed to evaluate two four-drug regimens compared with a three-drug regimen in patients who were relatively treatment naive. Based on the increased complexity and toxicity of four-drug regimens and the resultant negative impact on response as compared with three-drug regimens, studies evaluating simplified potent regimens appear warranted. This study will evaluate simpilified drug regimens designed to enhance virologic activity without necessarily increasing the number of antiretroviral drugs. The study regimens will be assessed for both virologic control and tolerability. The study population will include patients previously enrolled in ACTG 388 and patients with prior advanced HIV disease who received and responded to potent antiretroviral therapy without evidence of virologic relapse.
Patients will be stratified according to ACTG 388 treatment or non-ACTG 388 study participation. Patients will then be randomized to receive either a protease inhibitor (PI)-sparing regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) with efavirenz (EFV) (Arm I) or an NRTI-sparing regimen of EFV with lopinavir/ritonavir (LPV/r) (Arm II). Arm I options are enteric-coated didanosine (ddI-EC) plus lamivudine (3TC), ddI-EC plus zidovudine (ZDV), ZDV plus 3TC (or Combivir), stavudine (d4T) plus 3TC, or ddI-EC plus d4T (with exceptions as noted in the protocol). Only LPV/r, EFV, d4T, and ddI are provided by the study; other medications are obtained by nonstudy prescription.
All patients are evaluated for safety and for virologic and immunologic responses at Weeks 4 and 8, then every 8 weeks until the study ends. In addition, all patients have assessments for fat redistribution, fasting lipid profiles, fasting insulin levels, venous lactate levels, and treatment adherence.
Patients will be followed for 1.5 to 3 years. Interim safety analyses will be conducted in June 2002 and June 2003. Patients in this study may also enroll in A5125s, a fat distribution and bone mineral density substudy.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for ACTG 388 Participants
Inclusion Criteria for Non-ACTG 388 Participants
Inclusion Criteria for Both ACTG 388 and Non-ACTG 388 Participants
Exclusion Criteria for ACTG 388 Participants
Exclusion Criteria for ACTG 388 and Non-ACTG 388 Participants
Study Chair: | Margaret Fischl, MD | University of Miami |
Study ID Numbers: | ACTG A5116, AACTG 5116, Substudy AACTG A5124s, Substudy AACTG A5125s |
Study First Received: | April 14, 2001 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00014937 History of Changes |
Health Authority: | United States: Federal Government |
HIV-1 Didanosine Drug Therapy, Combination Zidovudine Nevirapine Stavudine HIV Protease Inhibitors Ritonavir Lamivudine |
RNA, Viral Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load ABT 378 Combivir Efavirenz Treatment Experienced |
Antimetabolites Efavirenz HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Stavudine Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Antiviral Agents Immunologic Deficiency Syndromes |
Protease Inhibitors Reverse Transcriptase Inhibitors Virus Diseases Nevirapine Didanosine Anti-Retroviral Agents Lopinavir Ritonavir HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors Efavirenz |
HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Didanosine HIV Infections Ritonavir Sexually Transmitted Diseases |