Study of Pharmacokinetics in HIV-infected Women

NCT00433979 | Completed

• 1 other identifier: HHP-79215
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 15

Brief Summary

Women represent an increasing proportion of HIV cases globally and in Canada, yet are underrepresented in clinic trials. It is therefore critical to conduct this study on antiretroviral (ARV) pharmacokinetics (PK) in women to obtain additional information on ARV drug levels in women and their relation to adverse events (AEs). The hypothesis for this study is three-fold:

1. 1.that the mean drug levels (Cmin and Cmax) of ARVs will be significantly higher in our female population as compared to the mean drug levels in the historical HIV population (which is primarily men)
2. 2.that ARV drug levels, particularly Cmin, are associated with body weight in women
3. 3.that higher ARV drug levels, particularly Cmax, are associated with higher frequency and severity of AEs.
4. 4.To demonstrate that levels of Protease Inhibitors (PIs) and Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) are significantly higher in our female population as compared to the mean drug levels in the historical general population (which is primarily men).
5. 5.To determine the association between PI and NNRTI minimum concentration (Cmin) and body weight in our female population.
6. 6.To determine the association between maximum concentration (Cmax) and the frequency and severity of AEs as measured by the proportion of patients with grade 2 or higher laboratory or clinical AEs and the Symptom Index Score in women.
7. 7.To determine the association between ARV drug levels and age, race, height, body mass index, adherence, hormonal levels and therapy, menstruation history, duration of HIV infection, duration on ARV therapy, baseline viral load, baseline CD4 count, present CD4 count, hepatitis B or C infection, class of ARVs, presence of ritonavir and other medications.

Conditions

HIV Infections

Keywords

Anti-HIV agents; Physiological Effects of Drugs; ARV-associated Adverse Events; HAART; Pharmacokinetics; Protease Inhibitors; Non-nucleoside Reverse Transcriptase Inhibitors; Women

Interventions

antiretroviral treatment DRUG

These antiretroviral drugs are a part of the participant's current drug regimen.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient population will consist of 80 HIV-infected women (who are on their first cART regimen containing either a PI or an NNRTI for at least three months and who have evidence of full virologic suppression (HIV RNA VL \< 50 copies/mL) on at least two occasions at least one month apart. The first cART regimen can include ARV switches as long as these switches are not due to virologic failure. The patient population is being limited to women who have full virologic suppression to avoid inclusion of women with difficulty with drug adherence.

You may qualify if:

• Patient must be HIV infected
• Patient must be 18 years old or older
• Patient must be a biologic woman
• Patient must be taking her first combination ARV regimen that includes a PI or an NNRTI for the past three months with no changes in any agent of the combination in that period (first combination ARV regimen is defined as a regimen started when the patient was ARV-naïve; however switches are allowed as long as the switches are not for virologic failure)
• Patient must be taking either a PI or an NNRTI but not both
• If taking a PI, patient must be taking only one PI excluding low dose ritonavir used as boosting
• Patient must have a viral load \< 50 copies/mL on two occasions at least 1 month apart including a value within three months before the baseline visit
• Patient has to have signed and dated a full informed consent

You may not qualify if:

• Patient who would have difficulty participating in a trial due to non-adherence or substance abuse
• Patient who is pregnant or breast-feeding
• Patient with a malignancy receiving systemic chemotherapy
• Patient with end stage organ disease
• Patient with other significant non-HIV underlying disease that might impinge upon disease progression or death
• Patient who is not taking standard dosing of a PI or NNRTI as listed in Appendix G

Sponsors & Collaborators

• Women's College Hospital: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (15)

Children and Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Downtown Infectious Diseases Clinic

Vancouver, British Columbia, V6Z 2C7, Canada

Location

Capital District Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Hamilton Health Sciences - McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

University of Ottawa Health Services

Ottawa, Ontario, K1N 6N5, Canada

Location

Ottawa Health Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Canadian Immunodeficiency Research Collaborative

Toronto, Ontario, M5B 1L6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Windsor Regional Hospital HIV Care Program

Windsor, Ontario, N8W 1E3, Canada

Location

Centre de recherche du Centre hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2W 1T7, Canada

Location

Montreal Chest Institute

Montreal, Quebec, H2X 2P4, Canada

Location

Chuq/Chul

Québec, Quebec, G1V 4G2, Canada

Location

Related Publications (1)

• Loutfy MR, Walmsley SL, Klein MB, Raboud J, Tseng AL, Blitz SL, Pick N, Conway B, Angel JB, Rachlis AR, Gough K, Cohen J, Haase D, Burdge D, Smaill FM, de Pokomandy A, Loemba H, Trottier S, la Porte CJ. Factors affecting antiretroviral pharmacokinetics in HIV-infected women with virologic suppression on combination antiretroviral therapy: a cross-sectional study. BMC Infect Dis. 2013 Jun 3;13:256. doi: 10.1186/1471-2334-13-256.

  PMID: 23732043 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be drawn before and after antiretroviral drugs are taken for visits 1-3.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mona R Loutfy, MD FRCPC MPH

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 9, 2007
• First Posted: February 12, 2007
• Study Start: February 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

CA (15)