Depot Contraception With and Without Lopinavir/Ritonavir

NCT01231451 | Withdrawn Phase 1

• 1 other identifier: SSAT 038
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

DMPA (depot medroxyprogesterone acetate or the 'depot' injection) is a widely used contraception. It is popular in woman with HIV as it probably still works when you take HIV drugs. HIV drugs can increase or decrease the level of other drugs (e.g. contraceptives) in your bloodstream which may make them work less well or increase side effects. It is assumed that DMPA can be given with HIV drugs there are no studies proving this. The purpose of the study is to investigate whether an HIV drug combination containing lopinavir/ritonavir affects DMPA when they are taken at the same time.

Conditions

HIV Infection

Keywords

HIV Infection

Outcome Measures

Primary Outcomes (1)

• pharmacokinetics of depot medroxyprogesterone acetate (DMPA)

  To investigate the pharmacokinetics of depot medroxyprogesterone acetate (DMPA) in the absence and presence of lopinavir/ritonavir in HIV- 1 infected women

  week 1 - week 24

Secondary Outcomes (3)

• Impact of co-administration of DMPA and lopinavir/ritonavir

  Week 1 - week 24

• Safety of DMPA

  Week 1 - week 24

• Impact of DMPA on lopinavir/ritonavir plasma concentrations

  week 1 - week 24

Study Arms (1)

All Subjects

EXPERIMENTAL

All Subjects will receive the same intervention

Drug: DMPA

Interventions

DMPA DRUG

All subjects will take DMPA

All Subjects

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The ability to understand and sign a written informed consent form, prior to participation in any screening procedure and must be willing to comply with all study requirements.
• Non-pregnant, non-lactating premenopausal females.
• No current hormonal contraception (short acting methods eg oral contraceptive pills and patches can be removed at screening)
• Regular menstrual periods such that DMPA can be administered between days 1-5 of menstrual cycle
• Between 18 and 45 years, inclusive.
• Documented HIV-1 infection
• Must be willing to use a barrier method of contraception to avoid pregnancy throughout the study, and for at least 56 days following completion of the study.
• CD4 count \> 200 at screening (Note: retesting of screening CD4 count allowed).
• Clinician and patient happy to delay HAART until week 12 of study
• Not currently on HAART and eligible to receive LPV/r and Truvada as determined by their primary HIV care provider in accordance with treatment guidelines
• If history of HAART exposure, no virological failure (prior drug switches allowed if for tolerability/toxicity/convenience of dosing).
• Agrees not to change regimen, outside the study recommendations, from baseline until end of the treatment period unless this is medically indicated as decided by the treating physician

You may not qualify if:

• Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include any active clinically significant renal, cardiac, hepatic, pulmonary, vascular, metabolic disorders or malignancy.
• Have a body mass index (BMI) \>35
• Personal history of venous thromboembolism (VTE) or pulmonary embolism (PE)
• Presence of any current active AIDS defining illness (Category C conditions in the CDC Classification System for HIV 1993) except stable cutaneous Kaposi's Sarcoma
• Osteoporosis or significant risk factors for osteoporosis (alcohol abuse, long-term anticonvulsants/corticosteroids, BMI less than 18, eating disorder, previous low trauma fracture, significant family history osteoporosis)
• Conditions for which DMPA is contra-indicated or risks outweigh benefits:
• Significant multiple risk factors for arterial cardiovascular disease
• Vascular disease
• Previous or current venous thromboembolism (VTE) or pulmonary embolism (PE)
• Ischaemic heart disease
• Stroke (history of cerebrovascular accident)
• Headaches migraine with aura, at any age
• Unexplained vaginal bleeding
• Gestational trophoblastic neoplasia (GTN) (includes hydatidiform mole, invasive mole, placental site trophoblastic tumour) hCG abnormal
• Breast cancer (past or current) or strong family history

Sponsors & Collaborators

• St Stephens Aids Trust: lead

Study Sites (1)

St Stephen's Centre

London, SW10 9NH, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

N,N-dimethyl-4-anisidine

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 Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 1, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 29, 2010

Record last verified: 2010-11

Locations

GB (1)