NCT00669487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

2.7 years

First QC Date

April 24, 2008

Last Update Submit

May 27, 2015

Conditions

HIV Infections

Keywords

HIV/AIDS patients

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in mean hemoglobin at 24 weeks and 72 weeks

    72 weeks

  • Proportion of participants with peripheral neuropathy at 24 weeks and 72 weeks

    72 weeks

Secondary Outcomes (4)

  • Changes from baseline in body weight, limb fat, and lean body mass by DEXA scan at 24 weeks and 72 weeks

    72 weeks

  • Change from baseline in serum creatinine at 24 weeks and 72 weeks

    72 weeks

  • Proportion of participants with plasma HIV-1 RNA less than 50 copies/mL at 24 weeks and 72 weeks

    72 weeks

  • Change from baseline in CD4 count at 24 weeks and 72 weeks

    72 weeks

Study Arms (3)

1. GPO-VIR S 1 pill orally every 12 hours

EXPERIMENTAL
Drug: AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP

2 GPO-VIR Z 1 pill orally every 12 hours

EXPERIMENTAL
Drug: AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP

3 Truvada 1 pill oral q 24 hr and NVP 1 pill oral q 12 hr

EXPERIMENTAL
Drug: AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP

Interventions

AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVPDRUG

Truvada(FTC200mg+TDF300mg) every 24 hours + NVP 200 mg every 12 hours orally until week 72

3 Truvada 1 pill oral q 24 hr and NVP 1 pill oral q 12 hr

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SEARCH Thailand

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jintanat - Ananworanich, M.D.

    SEARCH Thailand

    PRINCIPAL INVESTIGATOR

  • Jintanat - Ananworanich, M.D., Ph.D

    SEARCH Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jintanat Ananworanich

Study Record Dates

First Submitted

April 24, 2008

First Posted

April 30, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2010

Study Completion

April 1, 2011

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

TH(1)