Hormone Replacement Therapy and Anti-HIV Drugs in HIV-Infected, Postmenopausal Women

NCT00044837 | Terminated Phase 1

• 2 other identifiers: ACTG A5119AACTG A5119
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if the anti-HIV drugs nelfinavir (NFV), lopinavir/ritonavir (LPV/r), and efavirenz (EFV) change the amount of estrogen in the blood when taken along with hormone replacement therapy (HRT) for menopause. HRT can be helpful for treating bothersome symptoms of menopause. However, it is not routinely used in HIV-infected postmenopausal women because it is not known how HRT interacts with anti-HIV drugs. The information obtained from this study will help doctors make recommendations for HRT in postmenopausal HIV-infected women.

Conditions

HIV Infections

Keywords

Lopinavir; HIV-1; HIV Protease Inhibitors; Ritonavir; Postmenopause; Reverse Transcriptase Inhibitors; Pharmacokinetics; Area Under Curve; Hormone Replacement Therapy; efavirenz; estradiol

Interventions

Medroxyprogesterone acetate DRUG

Estradiol DRUG

Eligibility Criteria

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

You may qualify if:

• Patients may be eligible for this study if they:
• Are postmenopausal women over 18 years old.
• Are infected with HIV.
• Have a CD4 cell count of 100 cells/mm3 or greater within 45 days prior to study entry.
• Have a plasma viral load less than 55,000 copies/ml within 45 days prior to study entry.
• Are willing to comply with study requirements. These include not changing smoking habits during the course of the study and not consuming caffeine or alcohol prior to PK sampling.
• Have had a Pap smear within 12 months prior to study entry.
• Meet one of the following requirements: a) patients must currently be on stable PI or EFV regimens plus 2 or more acceptable NRTIs, or b) patients must not currently be taking any ARVs, with the exception of an NRTI-only regimen.
• Have a way to obtain their ARVs outside of the study and agree to continue their ARV regimen for at least 12 weeks of the study.

You may not qualify if:

• Patients may not be eligible for this study if they:
• Have had breast or endometrial cancer, thrombophlebitis, or thromboembolism.
• Have had serious nausea, vomiting, or abdominal pain within 30 days prior to study entry.
• Have had a serious illness requiring systemic treatment and/or hospitalization within 14 days prior to study entry.
• Are allergic or sensitive to the drugs that will be used for HRT.
• Have undiagnosed postmenopausal bleeding.
• Have coronary artery disease.
• Have used hormonal therapies within 8 weeks prior to study entry.
• Have used DMPA (Depo Provera) within 180 days prior to study entry.
• Have used the anti-HIV drugs ZDV and d4T at the same time within 30 days prior to study entry.
• Have used other medications specified in the protocol within 30 days prior to study entry.
• Are using experimental drugs without the written approval of the study co-chairs.
• Are unable to adhere to the ARV or HRT medications while on study, in the opinion of the investigator.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Barbara Brizz

Rockville, Maryland, 20852, United States

Location

Related Publications (4)

• Clark RA, Cohn SE, Jarek C, Craven KS, Lyons C, Jacobson M, Kamemoto L. Perimenopausal symptomatology among HIV-infected women at least 40 years of age. J Acquir Immune Defic Syndr. 2000 Jan 1;23(1):99-100. doi: 10.1097/00126334-200001010-00016. No abstract available.

  PMID: 10708064 BACKGROUND

• Gorski JC, Wang Z, Haehner-Daniels BD, Wrighton SA, Hall SD. The effect of hormone replacement therapy on CYP3A activity. Clin Pharmacol Ther. 2000 Oct;68(4):412-7. doi: 10.1067/mcp.2000.110560.

  PMID: 11061581 BACKGROUND

• Porter VR, Greendale GA, Schocken M, Zhu X, Effros RB. Immune effects of hormone replacement therapy in post-menopausal women. Exp Gerontol. 2001 Feb;36(2):311-26. doi: 10.1016/s0531-5565(00)00195-9.

  PMID: 11226745 BACKGROUND

• Ouellet D, Hsu A, Qian J, Locke CS, Eason CJ, Cavanaugh JH, Leonard JM, Granneman GR. Effect of ritonavir on the pharmacokinetics of ethinyl oestradiol in healthy female volunteers. Br J Clin Pharmacol. 1998 Aug;46(2):111-6. doi: 10.1046/j.1365-2125.1998.00749.x.

  PMID: 9723818 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Medroxyprogesterone Acetate; Estradiol

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

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Lori Kamemoto

  STUDY CHAIR

• Mary Vogler

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 5, 2002
• First Posted: September 9, 2002
• Last Updated: June 4, 2015

Record last verified: 2003-06

Locations

US (1)