Document Detail


Appropriateness of hydroxyethylcellulose gel as a placebo control in vaginal microbicide trials: a comparison of the two control arms of HPTN 035.
MedLine Citation:
PMID:  23334506     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To compare the 2 control arms of HPTN 035 [a hydroxyethylcellulose (HEC) gel control arm and a no-gel control arm] to assess the behavioral effects associated with gel use and direct causal effects of the HEC gel on sexually transmitted infections (STIs), pregnancy, and genital safety.
DESIGN: Randomized trial with 1 blinded (HEC gel) and 1 open-label (no-gel) control arms.
METHODS: HIV-uninfected, sexually active women were randomized into the HEC gel arm (n = 771) and into the no-gel arm (n = 772) in 5 countries. Participants in the HEC gel arm were instructed to insert the study gel intravaginally <1 hour before each vaginal sex act. Data on sexual behavior, adherence, safety, pregnancy, and STIs were collected quarterly for 12-30 months of follow-up.
RESULTS: During follow-up, mean reported condom use in the past week was significantly higher in the no-gel arm (81% versus 70%, P < 0.001). There were no significant differences, after adjusting for this differential condom use, between the 2 arms in the rates of genital safety events, pregnancy outcomes, or STIs, including HIV-1.
CONCLUSIONS: In this large randomized trial, we found no significant differences between the no-gel and HEC gel arms in the rates of genital safety events, pregnancy outcomes, or STIs. These results aid interpretation of the results of previous vaginal microbicide trials that used the HEC gel as a control. The HEC gel is suitable as a control for ongoing and future vaginal microbicide studies.
Authors:
Barbra A Richardson; Cliff Kelly; Gita Ramjee; Thomas Fleming; Bonus Makanani; Sarah Roberts; Petina Musara; Nkhafwire Mkandawire; Thomas Moench; Anne Coletti; Lydia Soto-Torres; Salim A Karim;
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  Journal of acquired immune deficiency syndromes (1999)     Volume:  63     ISSN:  1944-7884     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr.     Publication Date:  2013 May 
Date Detail:
Created Date:  2013-04-11     Completed Date:  2013-06-24     Revised Date:  2014-10-02    
Medline Journal Info:
Nlm Unique ID:  100892005     Medline TA:  J Acquir Immune Defic Syndr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  120-5     Citation Subset:  IM; X    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00074425
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MeSH Terms
Descriptor/Qualifier:
Administration, Intravaginal
Adult
Anti-Infective Agents / administration & dosage*,  adverse effects,  pharmacology
Cellulose / administration & dosage,  adverse effects,  analogs & derivatives*,  pharmacology
Female
Gels / administration & dosage*,  adverse effects,  pharmacology
HIV Infections / epidemiology,  prevention & control*
HIV-1
Humans
Male
Patient Compliance
Placebos / administration & dosage,  adverse effects,  pharmacology
Pregnancy
Pregnancy Outcome
Sexual Behavior
Sexually Transmitted Diseases / epidemiology,  prevention & control*
Treatment Outcome
Vagina / drug effects*
Grant Support
ID/Acronym/Agency:
U01 AI046749/AI/NIAID NIH HHS; U01 AI068633/AI/NIAID NIH HHS; U01AI068633/AI/NIAID NIH HHS; U01AI46749/AI/NIAID NIH HHS; UM1 AI068615/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/Anti-Infective Agents; 0/Gels; 0/Placebos; 9004-34-6/Cellulose; 9004-62-0/hydroxyethylcellulose
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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