Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00005918 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: May 4, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Efavirenz Drug: Lamivudine Drug: Stavudine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 730 participants |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | The Safety and Antiviral Efficacy of Stavudine Extended Release Formulation as Compared to Stavudine Immediate Release Formulation, Each as Part of Potent Antiretroviral Combination Therapy |
Study Start Date : | June 2000 |
Actual Primary Completion Date : | April 2002 |
Actual Study Completion Date : | April 2002 |


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: | 12 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
- Are at least 18 years old. Patients living in USA, Puerto Rico, Australia, Brazil, Singapore, and Thailand can be at least 12 years old (need consent of parent or guardian if under 18).
- Have a viral load of at least 2,000 copies/ml within 21 days of study entry.
- Have a CD4 count of at least 100 cells/mm3 within 21 days of study entry.
- Agree to use a barrier method of birth control (such as condoms) during the study.
- Are available for follow-up for at least 56 weeks.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Have taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 30 days and within 14 days of study entry.
- Have a new opportunistic (HIV-related) infection or condition requiring treatment.
- Have acute (early) HIV infection.
- Have diarrhea (at least 6 loose stools/day for at least 7 days in a row) within 30 days prior to study entry.
- Abuse alcohol or drugs.
- Have active hepatitis within 30 days prior to study entry.
- Have a history of peripheral neuropathy (a condition affecting the nervous system).
- Cannot take medications by mouth.
- Are allergic to certain antiviral drugs.
- Need to take certain medications that should not be taken with EFV.
- Have certain other conditions or prior treatments that might affect the study.

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): NCT00005918

Additional Information:
ClinicalTrials.gov Identifier: | NCT00005918 History of Changes |
Other Study ID Numbers: |
244F AI455-099 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | May 4, 2011 |
Last Verified: | April 2011 |
Keywords provided by Bristol-Myers Squibb:
Drug Therapy, Combination Stavudine Lamivudine RNA, Viral Dosage Forms |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load efavirenz |
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 Lamivudine Efavirenz Stavudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV 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 Antimetabolites |