Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study.
BACKGROUND
The Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort.


METHODS
HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count >or=250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed.


RESULTS
Of the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2-9) with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (<5%), except for Trichomonas vaginalis in 14% of HIV-1 infected women. Median baseline CD4 count for HIV-1 infected participants was 462cells/mcL and median HIV-1 plasma RNA was 4.2 log(10) copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log(10) copies/mL; p<0.001) and CD4 count (-0.25 and -0.55 log(10) copies/mL for CD4 350-499 and >500 relative to <350, respectively, p<0.001).


CONCLUSIONS
The Partners Study successfully enrolled a cohort of 3408 heterosexual HIV-1 serodiscordant couples in Africa at high risk for HIV-1 transmission. Follow-up of this cohort will evaluate the efficacy of acyclovir for HSV-2 suppression in preventing HIV-1 transmission and provide insights into biological and behavioral factors determining heterosexual HIV-1 transmission.


BACKGROUND
ClinicalTrials.gov NCT00194519.
Lingappa
Jairam R
JR
Department of Global Health, University of Washington, Seattle, Washington, United States of America.
Kahle
Erin
E
Mugo
Nelly
N
Mujugira
Andrew
A
Magaret
Amalia
A
Baeten
Jared
J
Bukusi
Elizabeth A
EA
Cohen
Craig R
CR
Katabira
Elly
E
Ronald
Allan
A
Kiarie
James
J
Farquhar
Carey
C
Stewart
Grace John
GJ
Makhema
Joseph
J
Essex
M
M
Were
Edwin
E
Fife
Kenneth
K
Debruyn
Guy
G
Gray
Glenda
G
McIntyre
James
J
Manongi
Rachel
R
Kapiga
Saidi
S
Coetzee
David
D
Allen
Susan
S
Inambao
Mubiana
M
Kayitenkore
Kayitesi
K
Karita
Etienne
E
Kanweka
William
W
Delany
Sinead
S
Rees
Helen
H
Vwalika
Bellington
B
Coombs
Robert W
RW
Morrow
Rhoda
R
Whittington
William
W
Corey
Lawrence
L
Wald
Anna
A
Celum
Connie
C
D000212:Acyclovir / Q000008:administration & dosage; D000328:Adult; D000349:Africa; D000998:Antiviral Agents / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000517:prevention & control / Q000635:transmission*; D015497:HIV-1 / Q000235:genetics; D006558:Herpes Genitalis / Q000188:drug therapy*; D018258:Herpesvirus 2, Human; D020010:Heterosexuality; D006801:Humans; D008297:Male; D012367:RNA, Viral / Q000097:blood; D012747:Sexual Partners; D012749:Sexually Transmitted Diseases
D000998:Antiviral Agents; D012367:RNA, Viral; D000212:Acyclovir