Louisville, Kentucky 40292

  • HIV Infections

Purpose:

The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine (d4T). One form is taken once a day (extended release) and the other form is taken twice a day (immediate release).


Study summary:

Patients are randomized to receive blinded stavudine extended release (d4T ER) or immediate release (d4T IR) formulation. Randomization is balanced by screening HIV viral load of less than 30,000 copies/ml or at least 30,000 copies/ml and by site. Patients also receive open-label efavirenz (EFV) and lamivudine (3TC). Efficacy is evaluated over 48 weeks of the dosing period and safety is evaluated over the entire dosing period (56 weeks).


Criteria:

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.


Study is Available At:


Original ID:

244F


NCT ID:

NCT00005918


Secondary ID:

AI455-099


Study Acronym:


Brief Title:

Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bristol-Myers Squibb


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Masking:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

730


Enrollment Type:


Study Dates

Start Date:June 2000
Completion Date:April 2002
Completion Type:Actual
Primary Completion Date:April 2002
Primary Completion Type:Actual
Verification Date:April 2011
Last Changed Date:April 28, 2011
First Received Date:June 15, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Stavudine
Intervention Type:Drug
Name:Lamivudine
Intervention Type:Drug
Name:Efavirenz

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bristol-Myers Squibb

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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