Status:
COMPLETED
A 72-week Randomized Clinical Trial Comparing the Safety and Efficacy of Three Initial Antiretroviral Regimens -GPO-VIR S (d4T/3TC/NVP) for 24 Weeks Followed by GPO-VIR Z (AZT/3TC/NVP) vs GPO-VIR Z vs TDF/FTC/NVP
Lead Sponsor:
SEARCH Research Foundation
Collaborating Sponsors:
Queen Savang Vadhana Memorial Hospital, Thailand
Thai Red Cross AIDS Research Centre
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This protocol aims to determine the risk/benefits of this policy by comparing head-to-head a regimen of GPO-VIR Z or TDF/FTC/NVP for 18 months in ARV-naïve patients to a 6-month lead in with GPO-VIR S...
Detailed Description
GPO-VIR Z is a new combination antiretroviral (ARV) medication that substitutes zidovudine (AZT) for stavudine (d4T) from the original formulation of GPO-VIR S. This new combination should decrease ra...
Eligibility Criteria
Inclusion
- Documented HIV-1 infection
- Age ≥ 18 years old.
- Subjects must be naïve to ARV. Individuals with past exposure to ARV associated with pregnancy will be allowed to enroll as long as the exposure is at least 3 months prior to entry.
- CD4 \< 350 cells/mm3
- Subject understands the study and is able to sign informed consent
Exclusion
- Evidence of symptomatic persistent symptoms of tingling or numbness of lower extremities and bilateral lower extremity neuropathy on exam at entry. Abnormal exam includes 1) Diminished (compared with the knee) or absent ankle reflexes OR 2) Diminution of either vibration sensation in the legs (defined as perception of vibration for \< 10 seconds at the great toe with a tuning fork initially struck hard enough to be audible) OR 3) Diminution of pin or temperature sensation in lower extremities OR 4) Contact allodynia in the feet.
- Laboratory values 1) Absolute neutrophil count (ANC) \< 750/mm3 2) Hemoglobin \< 8.0 g/dL 3) ALT (SGPT) \> 5 x ULN 4) Creatinine \> 2 X ULN or \< creatinine clearance \< 30 cc per min by Cockroft-Gault formula
- Active AIDS-defining opportunistic infection (OI) within 30 days prior to entry. Subjects must be off all acute treatments for OI for at least 14 days prior to entry. Subjects on maintenance or prophylactic therapy for AIDS-related OIs will be eligible.
- Any immunomodulator, HIV vaccine or investigational therapy within 30 days of study entry
- Pregnancy or breast-feeding; intent to become pregnant during the course of the study.
- Presence of any active malignancy.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00669487
Start Date
April 1 2008
End Date
April 1 2011
Last Update
May 28 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
SEARCH Thailand
Bangkok, Bangkok, Thailand, 10330