Study of effectiveness of Stavudine 20mg taken two times daily in patients suffering from HIV-1 infectio
- Conditions
- Health Condition 1: null- Antiretroviral-Naive Patients Infected With HIV-1
- Registration Number
- CTRI/2012/06/002716
- Lead Sponsor
- Wits Reproductive Health and HIV Institute WRHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Patient is male or female aged more than or equal to 18 years (upper limit of less than 65 years in India)
2. Patient has a documented laboratory diagnosis of infection with HIV-1 (positive enzyme-linked
immunosorbent assay HIV-1 antibody test) at screening or from previous records
3. Patient has a life expectancy of more than or equal to 2 years in the opinion of the investigator
4. Patient has a plasma HIV-1 RNA level more than 1000 copies/mL
5. Patient has a plasma CD4 count less than 350 cells/mm3 using standard flow cytometry within 60 days of baseline
6. Patient has the following clinical chemistry and haematological laboratory results at screening:
• Serum creatinine less than or equal 1.5 mg/dL (133 micromol/L) and a calculated creatinine clearance level more than or equal 60 mL/min according to the Cockcroft-Gault formula
• Serum alanine aminotransferase less than 5 × upper limit of normal (ULN)
• Serum aspartate aminotransferase less than 5 × ULN
• Serum lipase less than or equal 1.5 × ULN
Total bilirubin less than or equal 1.5 mg/dL (25 micromol/L) unless felt by clinician to be due to Gilbert syndrome
• Haemoglobin more than or equal 7.0 g/dL
• Absolute neutrophil count more than or equal 500/mm3
• Platelet count more than or equal 50 000/mm3
7. Female patients of childbearing potential, including those who are less than 2 years post-menopausal, must agree to, and comply with using a highly effective method of birth control (eg, barrier contraceptives
[condom or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables,
combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices, or sexual abstinence) while participating in this study. In addition, all women of childbearing potential must agree to continue to use birth control throughout the study until last study visit.
Women Not of Childbearing Potential - Women who are postmenopausal or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy). Women of Childbearing Potential (WOCBP) - Any female who has experienced menarche and does not meet the criteria for Women Not of Childbearing Potential.
8. Patient has the ability to comprehend the full nature and purpose of the study, in the opinion of the investigator, including possible risks and side effects, to cooperate with the investigator, to understand verbal and written instructions, and to comply with the requirements of the entire study
9. Patient is informed of the full nature and purpose of the study, including possible risks and side effects, given ample time and opportunity to read and understand this information, and sign and date the written informed consent before inclusion in the study
Patients meeting any of the following criteria will be excluded from the study:
1. Patients who have previously received treatment with any form of ART, including
preventing mother-to-child transmission regimens
2. Patients who are taking and can not discontinue the following prohibited concomitant
medications at least 1 week prior to the baseline visit and for the duration of the study
period:
Patients who are clinically unstable, in the investigator’s opinion, should be stabilized prior to inclusion into this study and their baseline concomitant medications should be stable for at least 1 month (30 days) prior to enrolment. In addition, investigators should not anticipate changing dose levels or medications for the duration of the study. Patients who, in the investigator’s opinion, require HIV-related prophylaxis (such as cotrimoxazole) and/or other HIV-related treatments (e.g. treatment for oral thrush, tuberculosis, etc) and who, in the investigator’s opinion are clinically stable may have such treatment initiated or discontinued during the screening period. The 30-day waiting period will not apply to the latter.
3. Patients who have a current history of drug or alcohol abuse that, in the opinion of the
investigator, may be an impediment to patient adherence to the protocol
4. Patients who have a medical history or evidence of gastrointestinal malabsorption
syndrome, chronic nausea, or vomiting which may prevent patients from receiving oral
medication
5. Patients who have participated in a study with an investigational drug within 60 days of
screening or who are currently receiving treatment with any other investigational drug or
device
6. Patients who are hepatitis B surface antigen positive
7. Patients with symptomatic peripheral neuropathies
8. Female patients who are currently pregnant or breastfeeding
9. Female patients desiring pregnancy during the next 2 years
10. Patients who have a strong likelihood of relocating far enough to make access to the
study site difficult
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint will be the proportion of patients with undetectable plasma HIV-1 RNA levels (less than 50 copies/mL) at Week 48. Patients who do not have a HIV-1 RNA sample taken at Week 48 will be considered as not having achieved undetectable plasma HIV-1 RNA levels (less than 50 copies/mL) at Week 48. <br/ ><br>Timepoint: Week 48. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Change from baseline in plasma CD4 levels by visitTimepoint: By visit;Change from baseline in plasma HIV-1 RNA levels by visit.Timepoint: By visit.;Proportion of patients in each regimen with undetectable plasma HIV-1 RNA levels (less than 50 copies/mL) at Weeks 48 and 96Timepoint: Weeks 48 and 96;Proportion of patients with plasma HIV-1 RNA levels less than 200 copies/mL at Week 96Timepoint: Week 96;Time to virologic failure (defined as confirmed HIV-1 RNA levels greater than or equal 1000 copies/mL at Week 12-24 or greater than or equal 200 copies/mL at or after Week 24)Timepoint: Week 12 - 24