Interactions Between Antiretrovirals (ARVs) and Combined... | NCT00829114

Studies
Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)

NCT00829114

Sponsor

FHI 360

Status

Completed

Last Update Posted

Oct 31, 2011Estimated

Enrollment

370Estimated

Phase

Phase 4

Conditions

HIV/AIDS
HIV Infections

Interventions

ETHINYL ESTRADIOL AND LEVOGESTREL
ETHINYL ESTRADIOL AND LEVOGESTREL

Countries

South Africa
Uganda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Jan 16, 2009

First Submission Date that Met QC Criteria

Jan 23, 2009

First Posted Date

Jan 26, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2011

Last Update Posted Date

Oct 31, 2011Estimated

Name	Class
United States Agency for International Development (USAID)	FED
Makerere University	OTHER
RHRU National Office, University of Witwatersand, Johannesburg	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

370Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	ART/COC group	Drug: ETHINYL ESTRADIOL AND LEVOGESTREL
2	Active Comparator	COC group	Drug: ETHINYL ESTRADIOL AND LEVOGESTREL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ETHINYL ESTRADIOL AND LEVOGESTREL	Drug	30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL	1

Measure	Description	Time Frame
Ovulation as determined by weekly blood progesterone (P) measurement		2 months

Measure	Description	Time Frame
Pregnancy as detected by monthly urine pregnancy testing		6 months
Adverse events (AE) recording		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willing to provide informed consent
Willing to take COCs and follow all study requirements
Has regular menstrual cycles every 21-35 days (when not taking hormonal contraception)
Last menstrual period (LMP) <35 days before study entry
Has body mass index of 18-30
Negative urine pregnancy test as enrollment
Documented HIV-1 infection
On nevirapine-containing ART for at least three months (ART group only)
CD4 cell count of greater than or equal to 350 (for non-ARV group only)
Currently sexually active and plans to stay sexually active for the next 6 months

Exclusion Criteria:

Medical contraindications to COC use
Recent pregnancy (within 3 months)
Has breastfed in last 3 months
Last pregnancy was ectpoic
Has been sterilized
Has had any of the following conditions since last pregnancy, or since menarche if never pregnant:

Pelvic Inflammatory disease Diagnosis of infertility

Has had DMPA within 6 months or NET injectable within 3 months of study entry (or has had no menses since last injection regardless of its timing)
has taken other hormonal therapies besides COCs (e.g., combined injectables, progestin implants or intrauterine systems, progestin-only contraceptive pills, medroxyprogesterone acetate, hormone replacement therapy) within 30 days of study entry
Has an acute infection or other opportunistic diseases requiring therapy within 14 days before enrollment
Has active drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
Has taken any prohibited medication within 30 days before study entry
Has chronic diarrhea, malabsorption or inability to maintain an adequate oral intake
Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or complicate data interpretation

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kavita Nanda, MD	FHI 360	Principal Investigator
Vera Halpern, MD	FHI 360	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
, RHRU National Office, University of Witwatersand		Esselent Saint Hillbrow	Johannesburg	2001	South Africa

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24088680	Derived	Nanda K, Delany-Moretlwe S, Dube K, Lendvay A, Kwok C, Molife L, Nakubulwa S, Edward VA, Mpairwe B, Mirembe FM. Nevirapine-based antiretroviral therapy does not reduce oral contraceptive effectiveness. AIDS. 2013 Oct;27 Suppl 1:S17-25. doi: 10.1097/QAD.0000000000000050.

ID	Term
D000163	Acquired Immunodeficiency Syndrome
D015658	HIV Infections

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

ID	Term
D009651	Norpregnatrienes
D009650	Norpregnanes
D009654	Norsteroids
D013256	Steroids