Women's Interagency HIV Study (WIHS)

HIV Infections Clinical Trial

Official title:

Women's Interagency HIV Study (WIHS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00000797
• Other study ID #: WIHS
• Status: Active, not recruiting
• Start date: October 1994
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2019
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Women's Interagency HIV Study (WIHS), a multicenter, prospective study, was established in August 1993 to carry out comprehensive investigations of the impact of HIV infection and its clinical, laboratory, and psychosocial effects in women. The purpose of this study is to collect and evaluate these data from HIV infected and at-risk women to better understand and provide support for women whom are currently HIV infected or who are at risk for HIV infection.

Description:

HIV in women is increasing worldwide, with women comprising approximately 14% of the total adult and adolescent AIDS cases, the highest proportion yet reported. The impact of AIDS is particularly severe in minority populations; among women, African Americans, and Hispanics combined now represent the majority of AIDS cases (76%) in the United States. AIDS is now the third leading cause of death for women aged 25 to 44 (after cancer and cardiovascular disease) and is the leading cause of death of African American women in this age group.

Studies of HIV and AIDS in women can play a unique role in testing new biological or socio-behavioral hypotheses at the population level and in linking basic science findings and laboratory methods to well-defined populations and communities. Research areas that are likely to draw more attention in the near future will include the study of pathogenicity and transmissibility of different HIV subtypes or recombinant forms and their interaction with variably susceptible individuals; the change in the scope of HIV natural history studies in the era of combination antiretroviral therapy; and the contribution of such studies to the design of a wide spectrum of prevention modalities (e.g., prevention of HIV and prevention of opportunistic infections). In addition, studies of natural history of HIV-related malignancies and active surveillance of malignancies in HIV infected and high-risk uninfected women may lead to new screening and prevention modalities in high-risk populations of women.

Participants will have study visits every 6 months. Questionnaires regarding sexual behavior, health care utilization, medical and obstetric/gynecological history, psychosocial factors, and sociodemographics will be completed by participants. Physical, gynecological, and lipodystrophy examinations will also be conducted at each visit, and current medication regimen will be noted. Blood and other bodily fluid samples will be collected and registered in both local and national repositories of the WIHS in conjunction with NIAID.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4982
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 55 Years

Eligibility

Inclusion Criteria:

• HIV infection

• Willing to be retested for HIV infection for this study unless hardcopy documentation of a positive result (HIV ELISA test and a confirmatory Western blot) is available

• Either have never taken HIV antiretroviral medications or have a documented start date of highly active antiretroviral therapy (HAART) after January 1, 2008

• If have taken HAART, have documentation of pre-HAART CD4 counts and HIV RNA quantification

• Willing and able to have blood drawn

• Give consent to have their specimens stored in the WIHS national repository

• Able to complete study visit interviews in English or Spanish every 6 months

• Able to travel to and from site clinic and participate in study visits as an outpatient

Exclusion Criteria:

• Perinatally acquired HIV

• Enrolled in the WIHS through another site

• HAART started before January 1, 2008, except during pregnancy

• Participant plans to move out of the area within 12 months

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	SUNY / Health Sciences Ctr at Brooklyn	Brooklyn	New York
United States	Chicago Consortium	Chicago	Illinois
United States	University of California - San Francisco	San Francisco	California
United States	Georgetown Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (52)

Ahdieh-Grant L, Li R, Levine AM, Massad LS, Strickler HD, Minkoff H, Moxley M, Palefsky J, Sacks H, Burk RD, Gange SJ. Highly active antiretroviral therapy and cervical squamous intraepithelial lesions in human immunodeficiency virus-positive women. J Nat — View Citation

Ameli N, Bacchetti P, Morrow RA, Hessol NA, Wilkin T, Young M, Cohen M, Minkoff H, Gange SJ, Greenblatt RM. Herpes simplex virus infection in women in the WIHS: epidemiology and effect of antiretroviral therapy on clinical manifestations. AIDS. 2006 Apr 2 — View Citation

Anastos K, Barrón Y, Cohen MH, Greenblatt RM, Minkoff H, Levine A, Young M, Gange SJ. The prognostic importance of changes in CD4+ cell count and HIV-1 RNA level in women after initiating highly active antiretroviral therapy. Ann Intern Med. 2004 Feb 17;1 — View Citation

Anastos K, Kalish LA, Hessol N, Weiser B, Melnick S, Burns D, Delapenha R, DeHovitz J, Cohen M, Meyer W, Bremer J, Kovacs A. The relative value of CD4 cell count and quantitative HIV-1 RNA in predicting survival in HIV-1-infected women: results of the wom — View Citation

Augenbraun M, Goedert JJ, Thomas D, Feldman J, Seaberg EC, French AL, Robison E, Nowicki M, Terrault N. Incident hepatitis C virus in women with human immunodeficiency virus infection. Clin Infect Dis. 2003 Nov 15;37(10):1357-64. Epub 2003 Oct 14. — View Citation

Augenbraun M, Tarwater P, Greenblatt R, Cohen M, French A, Gore ME, Watts H, Preston-Martin S, Anastos K; Women's Interagency HIV Study (WIHS). Opportunistic infection prophylaxis in the women's interagency HIV study (WIHS). J Acquir Immune Defic Syndr. 2 — View Citation

Barrón Y, Cole SR, Greenblatt RM, Cohen MH, Anastos K, DeHovitz JA, Delapenha R, Gange SJ. Effect of discontinuing antiretroviral therapy on survival of women initiated on highly active antiretroviral therapy. AIDS. 2004 Jul 23;18(11):1579-84. — View Citation

Berhane K, Karim R, Cohen MH, Masri-Lavine L, Young M, Anastos K, Augenbraun M, Watts DH, Levine AM. Impact of highly active antiretroviral therapy on anemia and relationship between anemia and survival in a large cohort of HIV-infected women: Women's Int — View Citation

Cejtin HE, Jacobson L, Springer G, Watts DH, Levine A, Greenblatt R, Anastos K, Minkoff HL, Massad LS, Schmidt JB. Effect of hormonal contraceptive use on plasma HIV-1-RNA levels among HIV-infected women. AIDS. 2003 Jul 25;17(11):1702-4. — View Citation

Chu H, Gange SJ, Yamashita TE, Hoover DR, Chmiel JS, Margolick JB, Jacobson LP. Individual variation in CD4 cell count trajectory among human immunodeficiency virus-infected men and women on long-term highly active antiretroviral therapy: an application u — View Citation

Cole SR, Hernán MA, Robins JM, Anastos K, Chmiel J, Detels R, Ervin C, Feldman J, Greenblatt R, Kingsley L, Lai S, Young M, Cohen M, Muñoz A. Effect of highly active antiretroviral therapy on time to acquired immunodeficiency syndrome or death using margi — View Citation

DeHovitz JA, Kovacs A, Feldman JG, Anastos K, Young M, Cohen M, Gange SJ, Melnick S, Greenblatt RM. The relationship between virus load response to highly active antiretroviral therapy and change in CD4 cell counts: A report from the Women's interagency H — View Citation

Falusi O, French AL, Seaberg EC, Tien PC, Watts DH, Minkoff H, Piessens E, Kovacs A, Anastos K, Cohen MH. Prevalence and predictors of Toxoplasma seropositivity in women with and at risk for human immunodeficiency virus infection. Clin Infect Dis. 2002 De — View Citation

Feldman JG, Burns DN, Gange SJ, Bacchetti P, Cohen M, Anastos K, Nowicki M, Delapena R, Miotti P. Serum albumin as a predictor of survival in HIV-infected women in the Women's Interagency HIV study. AIDS. 2000 May 5;14(7):863-70. — View Citation

Feldman JG, Gange SJ, Bacchetti P, Cohen M, Young M, Squires KE, Williams C, Goldwasser P, Anastos K. Serum albumin is a powerful predictor of survival among HIV-1-infected women. J Acquir Immune Defic Syndr. 2003 May 1;33(1):66-73. — View Citation

French AL, Benning L, Anastos K, Augenbraun M, Nowicki M, Sathasivam K, Terrault NA. Longitudinal effect of antiretroviral therapy on markers of hepatic toxicity: impact of hepatitis C coinfection. Clin Infect Dis. 2004 Aug 1;39(3):402-10. Epub 2004 Jul 1 — View Citation

French AL, Kirstein LM, Massad LS, Semba RD, Minkoff H, Landesman S, Palefsky J, Young M, Anastos K, Cohen MH. Association of vitamin A deficiency with cervical squamous intraepithelial lesions in human immunodeficiency virus-infected women. J Infect Dis. — View Citation

Gandhi M, Ameli N, Bacchetti P, Sharp GB, French AL, Young M, Gange SJ, Anastos K, Holman S, Levine A, Greenblatt RM. Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols. AIDS — View Citation

Greenspan D, Gange SJ, Phelan JA, Navazesh M, Alves ME, MacPhail LA, Mulligan R, Greenspan JS. Incidence of oral lesions in HIV-1-infected women: reduction with HAART. J Dent Res. 2004 Feb;83(2):145-50. — View Citation

Greenspan D, Komaroff E, Redford M, Phelan JA, Navazesh M, Alves ME, Kamrath H, Mulligan R, Barr CE, Greenspan JS. Oral mucosal lesions and HIV viral load in the Women's Interagency HIV Study (WIHS). J Acquir Immune Defic Syndr. 2000 Sep 1;25(1):44-50. — View Citation

Hessol NA, Anastos K, Levine AM, Ameli N, Cohen M, Young M, Augenbraun M, Miotti P, Gange SJ. Factors associated with incident self-reported AIDS among women enrolled in the women's interagency HIV study (WIHS). WIHS Collaboratorive Study Group. AIDS Res — View Citation

Hessol NA, Seaberg EC, Preston-Martin S, Massad LS, Sacks HS, Silver S, Melnick S, Abulafia O, Levine AM; WIHS Collaborative Study Group. Cancer risk among participants in the women's interagency HIV study. J Acquir Immune Defic Syndr. 2004 Aug 1;36(4):97 — View Citation

Justman JE, Benning L, Danoff A, Minkoff H, Levine A, Greenblatt RM, Weber K, Piessens E, Robison E, Anastos K. Protease inhibitor use and the incidence of diabetes mellitus in a large cohort of HIV-infected women. J Acquir Immune Defic Syndr. 2003 Mar 1; — View Citation

Kirstein LM, Greenblatt RM, Anastos K, Levine A, French AL, Minkoff H, Silver S, Gange SJ; Women's Interagency HIV Study Collaborative Research Group. Prevalence and correlates of highly active antiretroviral therapy switching in the Women's Interagency H — View Citation

Kovacs A, Wasserman SS, Burns D, Wright DJ, Cohn J, Landay A, Weber K, Cohen M, Levine A, Minkoff H, Miotti P, Palefsky J, Young M, Reichelderfer P; DATRI Study Group; WIHS Study Group. Determinants of HIV-1 shedding in the genital tract of women. Lancet. — View Citation

Landay A, Benning L, Bremer J, Weiser B, Burger H, Nowicki M, Kovacs A. Correlates of immune activation marker changes in human immunodeficiency virus (HIV)-seropositive and high-risk HIV-seronegative women who use illicit drugs. J Infect Dis. 2003 Jul 15 — View Citation

Levine AM, Berhane K, Masri-Lavine L, Sanchez M, Young M, Augenbraun M, Cohen M, Anastos K, Newman M, Gange SJ, Watts H. Prevalence and correlates of anemia in a large cohort of HIV-infected women: Women's Interagency HIV Study. J Acquir Immune Defic Synd — View Citation

Liu C, Weber K, Robison E, Hu Z, Jacobson LP, Gange SJ. Assessing the effect of HAART on change in quality of life among HIV-infected women. AIDS Res Ther. 2006 Mar 20;3:6. — View Citation

Massad LS, Riester KA, Anastos KM, Fruchter RG, Palefsky JM, Burk RD, Burns D, Greenblatt RM, Muderspach LI, Miotti P. Prevalence and predictors of squamous cell abnormalities in Papanicolaou smears from women infected with HIV-1. Women's Interagency HIV — View Citation

Massad LS, Seaberg EC, Watts DH, Hessol NA, Melnick S, Bitterman P, Anastos K, Silver S, Levine AM, Minkoff H. Low incidence of invasive cervical cancer among HIV-infected US women in a prevention program. AIDS. 2004 Jan 2;18(1):109-13. — View Citation

Massad LS, Springer G, Jacobson L, Watts H, Anastos K, Korn A, Cejtin H, Stek A, Young M, Schmidt J, Minkoff H. Pregnancy rates and predictors of conception, miscarriage and abortion in US women with HIV. AIDS. 2004 Jan 23;18(2):281-6. — View Citation

Minkoff H, Ahdieh L, Massad LS, Anastos K, Watts DH, Melnick S, Muderspach L, Burk R, Palefsky J. The effect of highly active antiretroviral therapy on cervical cytologic changes associated with oncogenic HPV among HIV-infected women. AIDS. 2001 Nov 9;15( — View Citation

Minkoff H, Ahdieh L, Watts H, Greenblatt RM, Schmidt J, Schneider M, Stek A. The relationship of pregnancy to the use of highly active antiretroviral therapy. Am J Obstet Gynecol. 2001 May;184(6):1221-7. — View Citation

Mirmirani P, Hessol NA, Maurer TA, Berger TG, Nguyen P, Khalsa A, Gurtman A, Micci S, Young M, Holman S, Gange SJ, Greenblatt RM. Prevalence and predictors of skin disease in the Women's Interagency HIV Study (WIHS). J Am Acad Dermatol. 2001 May;44(5):785 — View Citation

Mulligan R, Phelan JA, Brunelle J, Redford M, Pogoda JM, Nelson E, Seirawan H, Greenspan JS, Navazesh M, Greenspan D, Alves ME. Baseline characteristics of participants in the oral health component of the Women's Interagency HIV Study. Community Dent Oral — View Citation

Navazesh M, Mulligan R, Barrón Y, Redford M, Greenspan D, Alves M, Phelan J; Women's Interagency HIV Study participants. A 4-year longitudinal evaluation of xerostomia and salivary gland hypofunction in the Women's Interagency HIV Study participants. Oral — View Citation

Navazesh M, Mulligan R, Pogoda J, Greenspan D, Alves M, Phelan J, Greenspan J, Slots J. The effect of HAART on salivary microbiota in the Women's Interagency HIV Study (WIHS). Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Dec;100(6):701-8. Epub 2 — View Citation

Palacio H, Li X, Wilson TE, Sacks H, Cohen MH, Richardson J, Young M, Muñoz A; Women's Interagency HIV Study (WIHS). Healthcare use by varied highly active antiretroviral therapy (HAART) strata: HAART use, discontinuation, and naivety. AIDS. 2004 Mar 5;18 — View Citation

Philpott S, Weiser B, Tarwater P, Vermund SH, Kleeberger CA, Gange SJ, Anastos K, Cohen M, Greenblatt RM, Kovacs A, Minkoff H, Young MA, Miotti P, Dupuis M, Chen CH, Burger H. CC chemokine receptor 5 genotype and susceptibility to transmission of human im — View Citation

Preston-Martin S, Kirstein LM, Pogoda JM, Rimer B, Melnick S, Masri-Lavine L, Silver S, Hessol N, French AL, Feldman J, Sacks HS, Deely M, Levine AM. Use of mammographic screening by HIV-infected women in the Women's Interagency HIV Study (WIHS). Prev Med — View Citation

Richardson JL, Martin EM, Jimenez N, Danley K, Cohen M, Carson VL, Sinclair B, Racenstein JM, Reed RA, Levine AM. Neuropsychological functioning in a cohort of HIV infected women: importance of antiretroviral therapy. J Int Neuropsychol Soc. 2002 Sep;8(6) — View Citation

Schneider MF, Gange SJ, Williams CM, Anastos K, Greenblatt RM, Kingsley L, Detels R, Muñoz A. Patterns of the hazard of death after AIDS through the evolution of antiretroviral therapy: 1984-2004. AIDS. 2005 Nov 18;19(17):2009-18. — View Citation

Silverberg MJ, Ahdieh L, Munoz A, Anastos K, Burk RD, Cu-Uvin S, Duerr A, Greenblatt RM, Klein RS, Massad S, Minkoff H, Muderspach L, Palefsky J, Piessens E, Schuman P, Watts H, Shah KV. The impact of HIV infection and immunodeficiency on human papillomav — View Citation

Silverberg MJ, Gore ME, French AL, Gandhi M, Glesby MJ, Kovacs A, Wilson TE, Young MA, Gange SJ. Prevalence of clinical symptoms associated with highly active antiretroviral therapy in the Women's Interagency HIV Study. Clin Infect Dis. 2004 Sep 1;39(5):7 — View Citation

Stancliff S, Abel S, Agins B. Oral mucosal lesions and HIV viral load in the Women's Interagency HIV Study (WIHS). J Acquir Immune Defic Syndr. 2001 May 1;27(1):96-7. — View Citation

Strickler HD, Palefsky JM, Shah KV, Anastos K, Klein RS, Minkoff H, Duerr A, Massad LS, Celentano DD, Hall C, Fazzari M, Cu-Uvin S, Bacon M, Schuman P, Levine AM, Durante AJ, Gange S, Melnick S, Burk RD. Human papillomavirus type 16 and immune status in h — View Citation

Szczech LA, Gange SJ, van der Horst C, Bartlett JA, Young M, Cohen MH, Anastos K, Klassen PS, Svetkey LP. Predictors of proteinuria and renal failure among women with HIV infection. Kidney Int. 2002 Jan;61(1):195-202. — View Citation

Szczech LA, Hoover DR, Feldman JG, Cohen MH, Gange SJ, Goozé L, Rubin NR, Young MA, Cai X, Shi Q, Gao W, Anastos K. Association between renal disease and outcomes among HIV-infected women receiving or not receiving antiretroviral therapy. Clin Infect Dis. — View Citation

Tien PC, Cole SR, Williams CM, Li R, Justman JE, Cohen MH, Young M, Rubin N, Augenbraun M, Grunfeld C. Incidence of lipoatrophy and lipohypertrophy in the women's interagency HIV study. J Acquir Immune Defic Syndr. 2003 Dec 15;34(5):461-6. — View Citation

Viscidi RP, Ahdieh-Grant L, Schneider MF, Clayman B, Massad LS, Anastos KM, Burk RD, Minkoff H, Palefsky J, Levine A, Strickler H. Serum immunoglobulin A response to human papillomavirus type 16 virus-like particles in human immunodeficiency virus (HIV)-p — View Citation

Wilson TE, Barrón Y, Cohen M, Richardson J, Greenblatt R, Sacks HS, Young M; Women's Interagency HIV Study. Adherence to antiretroviral therapy and its association with sexual behavior in a national sample of women with human immunodeficiency virus. Clin — View Citation

Wilson TE, Gore ME, Greenblatt R, Cohen M, Minkoff H, Silver S, Robison E, Levine A, Gange SJ. Changes in sexual behavior among HIV-infected women after initiation of HAART. Am J Public Health. 2004 Jul;94(7):1141-6. — View Citation

* Note: There are 52 references in all — Click here to view all references

External Links

•   Click here for the WIHS homepage.