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HIV genital shedding and safety of Carraguard use by HIV-infected women: a crossover trial in Thailand.
AIDS. 2010 Mar 13; 24(5):717-22.AIDS

Abstract

OBJECTIVE

To evaluate the safety, including impact on genital HIV RNA shedding, of Carraguard vaginal gel in HIV-infected women.

DESIGN

This is a randomized, controlled, crossover study of Carraguard in HIV-infected women in Thailand.

METHODS

Each woman (CD4 cell count 51-500 cells/microl and not on antiretroviral therapy) used each treatment (Carraguard, methylcellulose placebo, and no-product) once daily for 7 days during each 1-month period (3-week wash-out). Women were randomized to one of the six possible treatment sequences. Safety assessments were conducted at baseline (pregel), 15 min postgel, day 7, and day 14, and included HIV RNA measurements in cervicovaginal lavage (CVL) specimens.

RESULTS

Sixty women were enrolled, and 99% of scheduled study visits were completed. At baseline, median age (34 years), CD4 lymphocyte count (296 cells/microl), plasma HIV viral load (4.6 log10 copies/ml), CVL HIV viral load (3.1 log10 total copies per CVL), and sexual behaviors were similar among randomization groups. HIV viral load, leukocyte and hemoglobin levels, and epithelial cell counts in CVLs were lower 15 min after application of Carraguard or placebo compared with no product; CVL HIV viral load was still lower at day 7 but returned to baseline by day 14. Carraguard use was not associated with prevalent or incident genital findings or abnormal vaginal flora.

CONCLUSION

Carraguard appears to be well tolerated for once-daily vaginal use by HIV-infected women. The observed reduction in CVL HIV viral load in the gel months may be clinically relevant but could have resulted from interference with sample collection by study gels.

Authors+Show Affiliations

Centers for Disease Control and Prevention, Atlanta, Georgia, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

20098295

Citation

McLean, Catherine A., et al. "HIV Genital Shedding and Safety of Carraguard Use By HIV-infected Women: a Crossover Trial in Thailand." AIDS (London, England), vol. 24, no. 5, 2010, pp. 717-22.
McLean CA, van de Wijgert JH, Jones HE, et al. HIV genital shedding and safety of Carraguard use by HIV-infected women: a crossover trial in Thailand. AIDS. 2010;24(5):717-22.
McLean, C. A., van de Wijgert, J. H., Jones, H. E., Karon, J. M., McNicoll, J. M., Whitehead, S. J., Braunstein, S., Achalapong, J., Chaikummao, S., Tappero, J. W., Markowitz, L. E., & Kilmarx, P. H. (2010). HIV genital shedding and safety of Carraguard use by HIV-infected women: a crossover trial in Thailand. AIDS (London, England), 24(5), 717-22. https://doi.org/10.1097/QAD.0b013e328333bf89
McLean CA, et al. HIV Genital Shedding and Safety of Carraguard Use By HIV-infected Women: a Crossover Trial in Thailand. AIDS. 2010 Mar 13;24(5):717-22. PubMed PMID: 20098295.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - HIV genital shedding and safety of Carraguard use by HIV-infected women: a crossover trial in Thailand. AU - McLean,Catherine A, AU - van de Wijgert,Janneke Hhm, AU - Jones,Heidi E, AU - Karon,John M, AU - McNicoll,Janet M, AU - Whitehead,Sara J, AU - Braunstein,Sarah, AU - Achalapong,Jullapong, AU - Chaikummao,Supaporn, AU - Tappero,Jordan W, AU - Markowitz,Lauri E, AU - Kilmarx,Peter H, PY - 2010/1/26/entrez PY - 2010/1/26/pubmed PY - 2011/2/4/medline SP - 717 EP - 22 JF - AIDS (London, England) JO - AIDS VL - 24 IS - 5 N2 - OBJECTIVE: To evaluate the safety, including impact on genital HIV RNA shedding, of Carraguard vaginal gel in HIV-infected women. DESIGN: This is a randomized, controlled, crossover study of Carraguard in HIV-infected women in Thailand. METHODS: Each woman (CD4 cell count 51-500 cells/microl and not on antiretroviral therapy) used each treatment (Carraguard, methylcellulose placebo, and no-product) once daily for 7 days during each 1-month period (3-week wash-out). Women were randomized to one of the six possible treatment sequences. Safety assessments were conducted at baseline (pregel), 15 min postgel, day 7, and day 14, and included HIV RNA measurements in cervicovaginal lavage (CVL) specimens. RESULTS: Sixty women were enrolled, and 99% of scheduled study visits were completed. At baseline, median age (34 years), CD4 lymphocyte count (296 cells/microl), plasma HIV viral load (4.6 log10 copies/ml), CVL HIV viral load (3.1 log10 total copies per CVL), and sexual behaviors were similar among randomization groups. HIV viral load, leukocyte and hemoglobin levels, and epithelial cell counts in CVLs were lower 15 min after application of Carraguard or placebo compared with no product; CVL HIV viral load was still lower at day 7 but returned to baseline by day 14. Carraguard use was not associated with prevalent or incident genital findings or abnormal vaginal flora. CONCLUSION: Carraguard appears to be well tolerated for once-daily vaginal use by HIV-infected women. The observed reduction in CVL HIV viral load in the gel months may be clinically relevant but could have resulted from interference with sample collection by study gels. SN - 1473-5571 UR - https://www.unboundmedicine.com/medline/citation/20098295/HIV_genital_shedding_and_safety_of_Carraguard_use_by_HIV_infected_women:_a_crossover_trial_in_Thailand_ L2 - https://doi.org/10.1097/QAD.0b013e328333bf89 DB - PRIME DP - Unbound Medicine ER -