To evaluate effectiveness of rilpivirine compared to efavirenz as first-line treatment in patients with HIV infection.
Searches
A comprehensive unbiased search strategy will be developed to ensure as many relevant studies as possible are found.
The following electronic databases will be searched for RCTs: MEDLINE, EMBASE, LILACS, CINAHL, Cochrane central register of controlled trials (CENTRAL), AID search, WHO international clinical trial registry.
The abstract of relevant conferences, including international conferences on AIDS will also be reviewed.
The search will include the following MeSH terms in various combinations; Antiretroviral agents; HAART; rilpivirine; TMC278; efavirenz; EFV; NNRTI; Randomised controlled trials; controlled trials etc.
Types of study to be included
Randomised controlled trials
Condition or domain being studied
Human immunodeficiency virus infection/AIDS is a disease of the human immune disease system caused by Human immunodeficiency virus. HIV is transmitted primarily via unprotected sexual intercourse, contaminated blood transfusion and hypodermic needle, and from mother to child during pregnancy, delivery or breastfeeding.
Globally, as of 2010, approximately 34 million people have contracted HIV. The introduction of Highly Active Antiretroviral Therapy (HA-ART) in 1996 revolutionized the care of patients infected with HIV and drastically reduced the morbidity and mortality associated with HIV infection.
WHO guidelines recommend initiation of HA-ART with three drug regimen containing either a Non-nucleoside reverse transcriptase inhibitor, Protease inhibitor or an integrase strand transfer inhibitor(INS-TI) plus two nucleoside/tide reverse transcriptase inhibitors.
Participants/ population
HIV infected adults and children treated with HA-ART without prior exposure to ART. Pregnant or lactating women and children under 5 years of age will be excluded.
Relevant sub-population of interest will include :
Patients with concurrent hepatitis B virus infection
Patients with concurrent hepatitis C virus infection
Patients with concurrent tuberculosis
Intervention(s), exposure(s)
HAART regimen containing Rilpivirine
Comparator(s)/ control
HAART regimen containing Efavirenz
Outcome(s)
Primary outcomes
1) Virological response – assessment of the number of participants achieving undetectable plasma HIV RNA concentration(viral load) over time
2) Death
Secondary outcomes
1) CD4 count
2) Treatment failure
3) Development of ART drug resistance
4) Opportunistic infection
5) Adverse events
6) Adherence
Data extraction, (selection and coding)
Two authors will independently extract data using a standardized data extraction form with the following characteristics extracted from each included study:
- Administrative detail
- Detail of study
- Characteristics of participants
- Details of intervention
- Outcome data
Risk of bias (quality) assessment
Two authors will independently assess the risk of bias for each trial. The following domains will be assessed as low risk of bias, unclear risk of bias or high risk of bias;
1) Random sequence generation
2) Allocation concealment
3) Blinding of participants and personnel
4) Blinding of outcome assessor
5) Incomplete outcome data
6) Selective reporting
7) Other bias sources of bias
Strategy for data synthesis
For dichotomous data, risk ratio(RR) will be used to measure treatment effect. For continuous data, arithmetic mean and standard deviation will be combined using mean differences. The relative risk and mean differences will be presented with 95% confidence intervals.
For missing data, we will attempt to contact authors if there is missing or unclear data.
Analysis of subgroups or subsets
ANALYSIS OF SUBGROUP OR SUBSET
If statistical heterogeneity is present, we will attempt to further investigate potentially influential study characteristics by conducting subgroup analysis e.g with respect to sex(males and females), viral load, CD4 cell count.
Contact details for further information
Adeniyi Ogunjale
Department of Community Health
Stellenbosch University
cape town
South Africa
ogunjaleniyi@yahoo.com
Organisational affiliation of the review
Stellenbosch University
www.sun.ac.za
Review team
Dr Adeniyi Ogunjale, Stellenbosch University Dr Charles Okwundu, Stellenbosch University
HIV Infections; HIV-1; Humans; Nitriles; Pyrimidines
Date of registration in PROSPERO
04 October 2012
Date of publication of this revision
04 October 2012
Stage of review at time of this submission
Started
Completed
Preliminary searches
Yes
Piloting of the study selection process
Formal screening of search results against eligibility criteria
Data extraction
Risk of bias (quality) assessment
Data analysis
Prospective meta-analysis
PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites.
