Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen
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ClinicalTrials.gov Identifier: NCT00135382 |
Recruitment Status
:
Completed
First Posted
: August 26, 2005
Last Update Posted
: February 17, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Videx EC Drug: Epivir Drug: Sustiva | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 254 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3 Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen |
Study Start Date : | June 2002 |
Actual Primary Completion Date : | October 2005 |
Actual Study Completion Date : | October 2005 |

- Efficacy at week 48
- Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 24 and 48

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Documented HIV infection
- ≥ 18 years of age and weight at least 40kg
- Two plasma HIV RNA levels < 50 copies/mL during the qualification and screening period
- Patients receiving a PI and ≥ 2 NRTIs
Exclusion Criteria:
- Pregnancy or breastfeeding
- Documented virologic failure while on their first PI-based antiretroviral (ARV) regimen
- Active AIDS-defining opportunistic infection or disease
- Proven or suspected acute hepatitis within 30 days prior to study entry

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): NCT00135382

Additional Information:
ClinicalTrials.gov Identifier: | NCT00135382 History of Changes |
Other Study ID Numbers: |
AI266-406 |
First Posted: | August 26, 2005 Key Record Dates |
Last Update Posted: | February 17, 2010 |
Last Verified: | January 2010 |
Keywords provided by Bristol-Myers Squibb:
HIV/AIDS |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Efavirenz Protease Inhibitors HIV Protease Inhibitors Reverse Transcriptase Inhibitors |
Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Anti-HIV Agents |