HIV InfectionsNCT00000797
Women's Interagency HIV Study (WIHS)
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 4,982 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 1994to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: HIV-infected women and HIV-uninfected women who are at risk of HIV infection
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203
Chicago Consortium
Chicago, Illinois, 60612
University of California - San Francisco
San Francisco, California, 94122
Montefiore Medical Center
The Bronx, New York, 10467
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
About this study
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.
Read the detailed 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.
- Conditions
- HIV Infections
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startOct 1994
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (60)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,982 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000797
- Sponsor's protocol ID
- WIHS
- Status last verified
- Jul 2019
- First submitted
- 2 Nov 1999
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Study Group. J Acquir Immune Defic Syndr. 1999 May 1;21(1):33-41. doi: 10.1097/00126334-199905010-00005.
PubMed 10235512Anastos 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 women's interagency HIV study. AIDS. 1999 Sep 10;13(13):1717-26. doi: 10.1097/00002030-199909100-00016.
PubMed 10509574Feldman 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. doi: 10.1097/00002030-200005050-00013.
PubMed 10839595DeHovitz 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 HIV study. J Infect Dis. 2000 Nov;182(5):1527-30. doi: 10.1086/315875. Epub 2000 Sep 27.
PubMed 11010840Levine 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 Syndr. 2001 Jan 1;26(1):28-35. doi: 10.1097/00126334-200101010-00004.
PubMed 11176266Minkoff 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. doi: 10.1067/mob.2001.113871.
PubMed 11349192French 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. 2000 Oct;182(4):1084-9. doi: 10.1086/315816. Epub 2000 Sep 1.
PubMed 10979903Greenspan 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. doi: 10.1097/00042560-200009010-00006.
PubMed 11064503Mirmirani 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):785-8. doi: 10.1067/mjd.2001.112350.
PubMed 11312425Stancliff 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. doi: 10.1097/00126334-200105010-00019. No abstract available.
PubMed 11404529Justman 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;32(3):298-302. doi: 10.1097/00126334-200303010-00009.
PubMed 12626890Kirstein 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 HIV Study. J Acquir Immune Defic Syndr. 2002 Apr 15;29(5):495-503. doi: 10.1097/00126334-200204150-00010.
PubMed 11981366Preston-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. 2002 Mar;34(3):386-92. doi: 10.1006/pmed.2001.1003.
PubMed 11902857Mulligan 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 Epidemiol. 2004 Apr;32(2):86-98. doi: 10.1111/j.0301-5661.2004.00128.x.
PubMed 15061857Strickler 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 human immunodeficiency virus-seropositive women. J Natl Cancer Inst. 2003 Jul 16;95(14):1062-71. doi: 10.1093/jnci/95.14.1062.
PubMed 12865452
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Interagency HIV Study (WIHS)
- ClinicalTrials.gov ID
- NCT00000797
- Acronym / sponsor ID
- WIHS
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,982 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 1994
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- HIV-infected women and HIV-uninfected women who are at risk of HIV infection
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Results publication: PubMed 10235512Massad 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 Study Group. J Acquir Immune Defic Syndr. 1999 May 1;21(1):33-41. doi: 10.1097/00126334-199905010-00005.
- Results publication: PubMed 10509574Anastos 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 women's interagency HIV study. AIDS. 1999 Sep 10;13(13):1717-26. doi: 10.1097/00002030-199909100-00016.
- Results publication: PubMed 10839595Feldman 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. doi: 10.1097/00002030-200005050-00013.
- Results publication: PubMed 11010840DeHovitz 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 HIV study. J Infect Dis. 2000 Nov;182(5):1527-30. doi: 10.1086/315875. Epub 2000 Sep 27.
- Results publication: PubMed 11176266Levine 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 Syndr. 2001 Jan 1;26(1):28-35. doi: 10.1097/00126334-200101010-00004.
- Results publication: PubMed 11349192Minkoff 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. doi: 10.1067/mob.2001.113871.
- Results publication: PubMed 10979903French 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. 2000 Oct;182(4):1084-9. doi: 10.1086/315816. Epub 2000 Sep 1.
- Results publication: PubMed 11064503Greenspan 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. doi: 10.1097/00042560-200009010-00006.
- Results publication: PubMed 11312425Mirmirani 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):785-8. doi: 10.1067/mjd.2001.112350.
- Results publication: PubMed 11404529Stancliff 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. doi: 10.1097/00126334-200105010-00019. No abstract available.
- Results publication: PubMed 12626890Justman 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;32(3):298-302. doi: 10.1097/00126334-200303010-00009.
- Results publication: PubMed 11981366Kirstein 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 HIV Study. J Acquir Immune Defic Syndr. 2002 Apr 15;29(5):495-503. doi: 10.1097/00126334-200204150-00010.
- Click here for the WIHS homepage.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000797, which also lists 60 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019; AzTrials last refreshed its copy on 6 Nov 2026.