Back to resultsA 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
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP
AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP
AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV/AIDS patients
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- SEARCH Thailand
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1. GPO-VIR S 1 pill orally every 12 hours
2 GPO-VIR Z 1 pill orally every 12 hours
3 Truvada 1 pill oral q 24 hr and NVP 1 pill oral q 12 hr
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in mean hemoglobin at 24 weeks and 72 weeks
Proportion of participants with peripheral neuropathy at 24 weeks and 72 weeks
Secondary Outcome Measures
Changes from baseline in body weight, limb fat, and lean body mass by DEXA scan at 24 weeks and 72 weeks
Change from baseline in serum creatinine at 24 weeks and 72 weeks
Proportion of participants with plasma HIV-1 RNA less than 50 copies/mL at 24 weeks and 72 weeks
Change from baseline in CD4 count at 24 weeks and 72 weeks
Full Information
NCT ID
NCT00669487
First Posted
April 24, 2008
Last Updated
May 27, 2015
Sponsor
SEARCH Research Foundation
Collaborators
Queen Savang Vadhana Memorial Hospital, Thailand, Thai Red Cross AIDS Research Centre, University of Hawaii
1. Study Identification
Unique Protocol Identification Number
NCT00669487
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SEARCH Research Foundation
Collaborators
Queen Savang Vadhana Memorial Hospital, Thailand, Thai Red Cross AIDS Research Centre, University of Hawaii
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 followed by 12 months of GPO-VIR Z. The primary outcomes to be assessed will be anemia, neuropathy, lipoatrophy and renal function.
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 rates of lipoatrophy and neuropathy which are side-effects strongly linked to the use of d4T. However, there is some risk that initiating therapy with an AZT- containing regimen may cause unacceptable rates of anemia. Many Thai physicians have adopted a practice of using 6 months of the stavudine-containing GPO-VIR S as a lead in before introducing AZT-containing GPO-VIR Z in an effort to balance the risks and benefits of these two medications. There are no definitive data, however, that can attest to the benefit of such an approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV/AIDS patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. GPO-VIR S 1 pill orally every 12 hours
Arm Type
Experimental
Arm Title
2 GPO-VIR Z 1 pill orally every 12 hours
Arm Type
Experimental
Arm Title
3 Truvada 1 pill oral q 24 hr and NVP 1 pill oral q 12 hr
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP
Intervention Description
Truvada(FTC200mg+TDF300mg) every 24 hours + NVP 200 mg every 12 hours orally until week 72
Intervention Type
Drug
Intervention Name(s)
AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP
Intervention Description
GPO-VIR S(D4T30mg+3TC150mg+NVP200mg)1 pill orally every 12 hours until week 24 and then switch to GPO-VIR Z
Intervention Type
Drug
Intervention Name(s)
AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP
Intervention Description
GPO-VIR Z(AZT250mg+3TC150mg+NVP200mg) 1 pill orally every 12 hours until week 72
Primary Outcome Measure Information:
Title
Change from baseline in mean hemoglobin at 24 weeks and 72 weeks
Time Frame
72 weeks
Title
Proportion of participants with peripheral neuropathy at 24 weeks and 72 weeks
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
Changes from baseline in body weight, limb fat, and lean body mass by DEXA scan at 24 weeks and 72 weeks
Time Frame
72 weeks
Title
Change from baseline in serum creatinine at 24 weeks and 72 weeks
Time Frame
72 weeks
Title
Proportion of participants with plasma HIV-1 RNA less than 50 copies/mL at 24 weeks and 72 weeks
Time Frame
72 weeks
Title
Change from baseline in CD4 count at 24 weeks and 72 weeks
Time Frame
72 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jintanat - Ananworanich, M.D.
Organizational Affiliation
SEARCH Thailand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jintanat - Ananworanich, M.D., Ph.D
Organizational Affiliation
SEARCH Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
SEARCH Thailand
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs