NCT00618176

Brief Summary

The purpose of this study is to determine whether the three generic nevirapine-based antiretroviral regimens are effective in the treatment of Acquired immune deficiency syndrome .

Trial Health

80
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P75+ for phase_4 hiv-infections

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

January 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
Last Updated

March 24, 2008

Status Verified

March 1, 2008

Enrollment Period

1.7 years

First QC Date

February 5, 2008

Last Update Submit

March 21, 2008

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndromeadverse effectsTreatment OutcomeDrug Resistance, Viraltreatment naïve

Study Arms (3)

B

EXPERIMENTAL
Drug: Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP)

A

EXPERIMENTAL
Drug: Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP)

C

EXPERIMENTAL
Drug: Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)

Interventions

Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP)DRUG

Zidovudine (AZT) 300mg bid Didanosine (ddI) 200mg bid (W\>60Kg)125mg bid (W\<60Kg) Nevirapine (NVP) 200mg bid

A
Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP)DRUG

Stavudine (d4T) 30mg bid (W\>60Kg)20mg bid (W\<60Kg) Lamivudine (3TC)300mg qd Nevirapine (NVP)200mg bid

B
Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)DRUG

Zidovudine (AZT) 300mg bid Lamivudine (3TC) 300mg qd Nevirapine (NVP) 200mg bid

C

Eligibility Criteria

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

You may qualify if:

  • years or older
  • the subjects were HIV-seropositive by standard serum enzyme-linked immunosorbent assay (ELISA) tests and also by Western blot analysis
  • the subjects were antiretroviral drug-naïve
  • a baseline CD4+ T-cell count from 100 to 350 cells/mm3 and a baseline plasma viral load over 500copies/ml

You may not qualify if:

  • pregnancy or breastfeeding
  • anticipated nonadherence
  • AIDS-defining illness within 2 weeks of entry
  • white blood cell count less than 2.0×109/L, absolute neutrophil count less than 1.0×109/L, hemoglobin level less than 90g/l, platelet count less than 0.75×1012/L
  • transaminase and alkaline phosphatase level more than 3 times the upper limit of the normal range, bilirubin level more than 2.5times the upper limit of the normal range, serum creatinine level more than 1.5 times the upper limit of the normal range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Related Publications (1)

  • Li T, Dai Y, Kuang J, Jiang J, Han Y, Qiu Z, Xie J, Zuo L, Li Y. Three generic nevirapine-based antiretroviral treatments in Chinese HIV/AIDS patients: multicentric observation cohort. PLoS One. 2008;3(12):e3918. doi: 10.1371/journal.pone.0003918. Epub 2008 Dec 12.

    PMID: 19081791DERIVED

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

ZidovudineStavudineLamivudineNevirapine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesZalcitabineDeoxycytidineCytidinePyridines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 18, 2008

Study Start

January 1, 2005

Primary Completion

September 1, 2006

Last Updated

March 24, 2008

Record last verified: 2008-03

Locations

CN(1)