Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients
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| ClinicalTrials.gov Identifier: NCT00050895 |
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Recruitment Status :
Completed
First Posted : January 1, 2003
Last Update Posted : November 1, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Lopinavir/ritonavir Drug: Efavirenz Drug: Stavudine Drug: Zidovudine Drug: Lamivudine Drug: Tenofovir disoproxil fumarate | Phase 3 |
Numerous treatment options are available to HIV infected patients who are antiretroviral (ARV) therapy naive, but an optimal regimen has not yet been established. This study will compare a nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimen, a ritonavir (RTV)-enhanced protease inhibitor (PI)-based regimen, and a nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimen for the initial treatment of HIV infection.
Patients will be randomly assigned to one of three study arms. In Arm A, patients will receive lopinavir/ritonavir (LPV/r) twice daily and efavirenz (EFV) once daily before bed. Arm B patients will receive LPV/r twice daily, lamivudine (3TC) once daily, plus either stavudine extended release (d4T XR) once daily, zidovudine (ZDV) twice daily, or tenofovir disoproxil fumarate (TDF) once daily. Patients in Arm C will receive EFV once daily before bed and 3TC plus either d4T XR once daily before bed, ZDV twice daily, or TDF once daily before bed.
Study visits will occur every 4 weeks until Week 24, then every 8 weeks thereafter for a maximum of 96 weeks. Blood will be drawn at every visit and a urine sample will be collected every 8 weeks. Body measurements will be taken at Weeks 24, 48, 72, and 96. Whole body dual-energy x-ray absorptiometry (DEXA) scans will be done at Weeks 48 and 96. Patients must fast before study visits at Weeks 12, 24, 48, 72, and 96. Women in the study will have gynecological assessments every 24 weeks.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 775 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III, Randomized, Open-Label Comparison of Lopinavir/Ritonavir Plus Efavirenz Versus Lopinavir/Ritonavir Plus 2 NRTIs Versus Efavirenz Plus 2 NRTIs as Initial Therapy for HIV-1 Infection |
| Actual Study Completion Date : | March 2006 |
- Time from study entry to virologic failure
- time from study entry to regimen completion
- 20 % or more loss in peripheral fat
- increase in lactic acid levels at least 2-4old above the upper limit of normal (ULN)
- 20 % or more increase in truncal fat accumulation
- fasting cholesterol level equal to or greater than 240 mg/dl
- Grade 3 or greater elevation in fasting triglyceride levels
- change from baseline in insulin resistance [ Time Frame: at Weeks 24, 48 and 96 ]
- change from baseline of whole-body bone density and whole-body bone mineral content [ Time Frame: at Weeks 48 and 96 ]
- time to confirmed virologic failure while on Steps I (initial randomized regimen) or II (within class substitutes for initial regimen toxicity) OR treatment-limiting toxicity on Steps I or II
- number of antiretroviral classes with resistance mutations at virologic failure
- number of missed medication doses [ Time Frame: 4 days prior ]
- change from baseline in self-reported symptoms OR occurrence of reporting an increase in symptoms [ Time Frame: at Weeks 4, 48, 72 and 96 ]
- change from baseline in body image OR occurrence of reporting body image distress [ Time Frame: at Weeks 24, 48, 72 and 96 ]
- time until treatment-limiting toxicity OR occurrence of Grades 3 or 4 toxicity
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria for Step 1:
- HIV infected
- HIV viral load of 2000 copies/ml or greater within 60 days prior to study entry
- Willing to use acceptable means of contraception
- d4T XR, TDF, or ZDV chosen as part of an initial regimen prior to randomization to a study arm
- Coenrolled in ACTG A5152s
Exclusion Criteria for Step 1:
- On ARV therapy for 7 days or more any time prior to study entry
- NNRTIs or 3TC at any time prior to study entry
- Current peripheral neuropathy of Grade 2 or higher
- Pregnancy or breastfeeding
- Immunomodulators, vaccines, or investigational therapies within 30 days of study entry. Patients taking a stable or tapering dose of prednisone at less than 10 mg are not excluded.
- Human growth hormone within 30 days prior to study entry
- Initiation of testosterone or anabolic steroids within 30 days prior to study entry
- Certain other medications within 30 days of study entry
- Hypersensitivity to components of the study drug formulations
- Drug or alcohol use or dependence that would interfere with adherence to study requirements
- Acute therapy for serious medical illnesses requiring systemic treatment and/or hospitalization within 14 days prior to study entry
- Recent infection with drug-resistant HIV
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050895
Show 60 study locations
| Study Chair: | Sharon Riddler, MD | University of Pittsburgh | |
| Study Chair: | Richard Haubrich, MD | University of California, San Diego, Division of Infectious Diseases |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00050895 |
| Other Study ID Numbers: |
A5142 10085 ( Registry Identifier: DAIDS ES ) ACTG A5142 A5152s A5160s |
| First Posted: | January 1, 2003 Key Record Dates |
| Last Update Posted: | November 1, 2021 |
| Last Verified: | October 2021 |
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Reverse Transcriptase Inhibitors HIV Protease Inhibitors Drug Therapy, Combination |
Delayed Action Preparations Treatment Naive HIV-1 |
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Infections Ritonavir Lopinavir Tenofovir Lamivudine Zidovudine Stavudine Efavirenz HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents |
Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Antimetabolites Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |