Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00005918




Registration number
NCT00005918
Ethics application status
Date submitted
15/06/2000
Date registered
31/08/2001
Date last updated
4/05/2011

Titles & IDs
Public title
Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients
Scientific 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
Secondary ID [1] 0 0
AI455-099
Secondary ID [2] 0 0
244F
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Efavirenz
Treatment: Drugs - Lamivudine
Treatment: Drugs - Stavudine

Treatment: Drugs: Efavirenz


Treatment: Drugs: Lamivudine


Treatment: Drugs: Stavudine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion 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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2002
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Hugo Ree MD - Brisbane
Recruitment hospital [2] 0 0
Prahran Market Clinic - South Yarra
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- South Yarra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Prov Bs As
Country [15] 0 0
Argentina
State/province [15] 0 0
Rosario Santa Fe
Country [16] 0 0
Argentina
State/province [16] 0 0
San Isidro
Country [17] 0 0
Belgium
State/province [17] 0 0
Gent
Country [18] 0 0
Belgium
State/province [18] 0 0
Liege
Country [19] 0 0
Brazil
State/province [19] 0 0
Belo Horizonte-MG
Country [20] 0 0
Brazil
State/province [20] 0 0
Botucatu-SP
Country [21] 0 0
Brazil
State/province [21] 0 0
Santos
Country [22] 0 0
Brazil
State/province [22] 0 0
Sao Paulo
Country [23] 0 0
Canada
State/province [23] 0 0
British Columbia
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
France
State/province [25] 0 0
Bordeaux
Country [26] 0 0
France
State/province [26] 0 0
Lyon Cedex 03
Country [27] 0 0
France
State/province [27] 0 0
Nantes
Country [28] 0 0
France
State/province [28] 0 0
Paris Cedex 13
Country [29] 0 0
France
State/province [29] 0 0
Rennes
Country [30] 0 0
Israel
State/province [30] 0 0
Rehovot
Country [31] 0 0
Israel
State/province [31] 0 0
Tel Hashomer
Country [32] 0 0
Italy
State/province [32] 0 0
Antella
Country [33] 0 0
Italy
State/province [33] 0 0
Bari
Country [34] 0 0
Italy
State/province [34] 0 0
Bergamo
Country [35] 0 0
Italy
State/province [35] 0 0
Milano
Country [36] 0 0
Italy
State/province [36] 0 0
Napoli
Country [37] 0 0
Italy
State/province [37] 0 0
Pisa
Country [38] 0 0
Italy
State/province [38] 0 0
Torino
Country [39] 0 0
Mexico
State/province [39] 0 0
Mexico City
Country [40] 0 0
Mexico
State/province [40] 0 0
Tijuana
Country [41] 0 0
Portugal
State/province [41] 0 0
Almada
Country [42] 0 0
Portugal
State/province [42] 0 0
Coimbra
Country [43] 0 0
Portugal
State/province [43] 0 0
Lisboa
Country [44] 0 0
Puerto Rico
State/province [44] 0 0
Coto Laurel, Ponce
Country [45] 0 0
Puerto Rico
State/province [45] 0 0
San Juan
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Moscow
Country [47] 0 0
Russian Federation
State/province [47] 0 0
St Petersburg
Country [48] 0 0
South Africa
State/province [48] 0 0
Cape Town
Country [49] 0 0
South Africa
State/province [49] 0 0
Johannesburg
Country [50] 0 0
South Africa
State/province [50] 0 0
Pretoria
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Spain
State/province [53] 0 0
Palma de Mallorca
Country [54] 0 0
Spain
State/province [54] 0 0
Pamplona
Country [55] 0 0
Thailand
State/province [55] 0 0
Bangkok
Country [56] 0 0
Thailand
State/province [56] 0 0
Nontaburi
Country [57] 0 0
State/province [57] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00005918
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00005918