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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00016601 |
The purpose of this study is to look at the level of depo-medroxyprogesterone acetate (DMPA or Depo-Provera) in the blood to see if is affected by certain anti-HIV drugs (nelfinavir [NFV], efavirenz [EFV], indinavir [IDV] in combination with ritonavir [RTV], and nevirapine [NVP]). This study will also look at the levels of these anti-HIV drugs to see if they are affected by DMPA.
DMPA is a hormonal birth control method that is given as an injection. It is not known if taking DMPA together with anti-HIV drugs changes the amount of DMPA and/or the amount of anti-HIV drugs in the blood. If higher levels of DMPA occur, side effects may increase. If lower levels of anti-HIV drugs occur, the drugs may become less effective against HIV. This study will look at the levels of anti-HIV drugs and DMPA in the blood when these medications are used together.
Condition | Intervention |
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HIV Infections |
Drug: Indinavir sulfate Drug: Ritonavir Drug: Nelfinavir mesylate Drug: Efavirenz Drug: Nevirapine Drug: Medroxyprogesterone acetate |
Study Type: | Interventional |
Study Design: | Treatment, Pharmacokinetics Study |
Official Title: | An Open-Label, Non-Randomized Study of Pharmacokinetic Interactions Between Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) and Selected Protease Inhibitor (PI) and Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI) Therapies Among HIV-Infected Women |
Estimated Enrollment: | 76 |
DMPA, an injectable depot formulation of medroxyprogesterone (MPA), is a commonly used form of "progestin-only" contraception. Information is limited on the specific P450 isozymes that metabolize MPA; however, it appears that CYP3A4 is 1 pathway of hepatic clearance. Drugs known to be inhibitors of the CYP3A4 pathway (such as protease inhibitors [PIs]) may lead to elevated concentrations of MPA. Secondly, MPA given as DMPA injections has been shown to induce the activity of CYP3A4 by 25 percent. It is possible that this action may result in enhanced clearance of the substrates of CYP3A4, including PIs and nonnucleoside reverse transcriptase inhibitors (NNRTIs), which in turn may result in reduced drug exposure and possible ARV failure. This study is designed to address the lack of information on potential interactions between PIs or NNRTIs and DMPA.
Patients are enrolled into 1 of 5 arms based on their current ARV regimen:
Arm A (control group): No current ARVs or receiving nucleoside reverse transcriptase inhibitors (NRTIs) only.
Arm B: NFV (1250 mg bid or 750 mg tid) in combination with NRTIs. Arm C: EFV (600 mg qd) in combination with NRTIs. Arm D: IDV (800 mg bid) and RTV (100 mg bid or 200 mg bid) in combination with NRTIs.
Arm E: NVP (200 mg bid) in combination with NRTIs. Acceptable NRTIs and any fixed combination of these medications include: zidovudine (ZDV), lamivudine, didanosine, stavudine (d4T), zalcitabine, and abacavir; concurrent therapy using ZDV and d4T is not allowed. ARV therapy is not provided by this study. One dose of DMPA is provided to all patients at entry (Day 0) and an optional dose of DMPA will be available at the final visit (Week 12) for those who are interested in continuing with DMPA outside of the protocol and who do not experience adverse events from the first DMPA injection. Patients in Arms B, C, D, and E have intensive pharmacokinetic sampling done at entry and at Week 4 to measure ARV levels. All patients have blood tests at Weeks 2, 4, 6, 8, 10, and 12 to measure levels of DMPA and progesterone. In addition, tests to monitor HIV-1 RNA levels, CD4 and CD8 counts, hematology, blood chemistries, and liver function are performed periodically.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Study Chair: | Susan Cohn |
Study ID Numbers: | ACTG A5093 |
Study First Received: | May 18, 2001 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00016601 |
Health Authority: | United States: Federal Government |
Delayed-Action Preparations Drug Interactions Drug Therapy, Combination Nevirapine HIV Protease Inhibitors Ritonavir Indinavir |
Nelfinavir Reverse Transcriptase Inhibitors Anti-HIV Agents Pharmacokinetics Medroxyprogesterone 17-Acetate efavirenz |
Efavirenz Sexually Transmitted Diseases, Viral Medroxyprogesterone 17-Acetate Indinavir Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases |
Nevirapine HIV Infections Ritonavir Sexually Transmitted Diseases Medroxyprogesterone Nelfinavir Retroviridae Infections |
Anti-Infective Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Contraceptive Agents Antineoplastic Agents Physiological Effects of Drugs Contraceptives, Oral Contraceptive Agents, Female Reproductive Control Agents Infection Contraceptive Agents, Male Reverse Transcriptase Inhibitors Anti-Retroviral Agents |
Therapeutic Uses Contraceptives, Oral, Synthetic Nucleic Acid Synthesis Inhibitors RNA Virus Infections HIV Protease Inhibitors Anti-HIV Agents Immune System Diseases Antineoplastic Agents, Hormonal Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Protease Inhibitors Lentivirus Infections |