Hormonal Birth Control and the Risk of Acquiring HIV

NCT00006324 | Completed

• 1 other identifier: HIVNET 021
• Study Type: interventional
• Target: 6,360
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out whether hormonal birth control increases, decreases, or does not change the risk of women becoming infected with HIV. Sexual intercourse between men and women is the main way HIV is transmitted. About 90 percent of HIV infections in women are caused by sexual intercourse. Also, hormonal birth controls are widely used. This study hopes to find out whether hormonal birth control changes the risk of women becoming infected with HIV.

Conditions

HIV Infections

Keywords

HIV Seronegativity; Delayed-Action Preparations; Risk Factors; Prevalence; Contraceptive Agents, Female; Contraceptives, Oral, Combined; Medroxyprogesterone 17-Acetate

Interventions

Ethinyl estradiol/levonorgestrel DRUG

Medroxyprogesterone acetate DRUG

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women may be eligible for this study if they:
• Are 16 to 35 years of age.
• Attend family planning and maternal and child health clinics in Zimbabwe, Thailand, or Uganda.
• Have been using low-dose birth control pills, DMPA injections, or non-hormonal birth control (condoms, sterilization, or no modern birth control method) for at least 3 months and plan to continue using the same type of birth control for a year.
• Are HIV-negative.
• Are sexually active.
• Are at least 4.5 months after delivery, if they have given birth.
• Agree to all study procedures, including HIV testing every 3 months, follow-up clinic visits, and home visits if they fail to return for follow-up.
• Have a home address where they can be reached for follow-up visits.

You may not qualify if:

• Women will not be eligible for this study if they:
• Are pregnant or plan to try to become pregnant in the next year. Women who become pregnant after enrolling in the trial will not be discontinued.
• Are not currently using low-dose birth control pills or DMPA for birth control but have used low-dose birth control pills within the last 3 months, or DMPA for birth control within the previous 6 months.
• Are HIV-indeterminate or HIV-positive.
• Have used an IUD for birth control in the last month.
• Have used non-study types of birth control (such as Norplant, NET-EN, or progestin-only pills) within the last 3 months.
• Have had a full hysterectomy.
• Have had an abortion or miscarriage within the last month.
• Have had a blood transfusion within the last 3 months.
• Were previously or are currently in an HIV vaccine trial.
• Injected illegal drugs within the last 3 months.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Amy Lovvorn

Research Triangle Park, North Carolina, 27709, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Ethinyl Estradiol-Norgestrel Combination; Medroxyprogesterone Acetate

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)

Ethinyl Estradiol; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norgestrel; Norpregnenes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes

Study Officials

• Charles Morrison

  STUDY CHAIR

• Barbra Richardson

  STUDY CHAIR

• Sungwal Rugpao

  PRINCIPAL INVESTIGATOR

• Roy Mugerwa

  PRINCIPAL INVESTIGATOR

• Francis Mmiro

  PRINCIPAL INVESTIGATOR

• Tsungai Chipato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 2, 2000
• First Posted: August 31, 2001
• Study Start: December 1, 1999
• Study Completion: December 1, 2002
• Last Updated: August 7, 2008

Record last verified: 2006-11

Locations

US (1)