RETROVIR (ZIDOVUDINE) HAS BEEN ASSOCIATED WITH HEMATOLOGIC TOXICITY, INCLUDING NEUTROPENIA AND SEVERE ANEMIA, PARTICULARLY IN PATIENTS WITH ADVANCED HIV DISEASE (SEE WARNINGS). PROLONGED USE OF RETROVIR HAS BEEN ASSOCIATED WITH SYMPTOMATIC MYOPATHY. LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING RETROVIR AND OTHER ANTIRETROVIRALS (SEE WARNINGS).
RETROVIR I.V. SUMMARY
RETROVIR is the brand name for zidovudine (formerly called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against human immunodeficiency virus (HIV). RETROVIR IV Infusion is a sterile solution for intravenous infusion only. Each mL contains 10 mg zidovudine in Water for Injection. Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH to approximately 5.5. RETROVIR IV Infusion contains no preservatives.
RETROVIR IV Infusion in combination with other antire-troviral agents is indicated for the treatment of HIV infection.
Maternal-Fetal HIV Transmission: RETROVIR is also indicated for the prevention of maternal-fetal HIV transmission as part of a regimen that includes oral RETROVIR beginning between 14 and 34 weeks of gestation, intravenous RETROVIR during labor, and administration of RETROVIR Syrup to the neonate after birth. The efficacy of this regimen for preventing HIV transmission in women who have received RETROVIR for a prolonged period before pregnancy has not been evaluated. The safety of RETROVIR for the mother or fetus during the first trimester of pregnancy has not been assessed (see Description of Clinical Studies).
Published Studies Related to Retrovir I.V. (Zidovudine Intravenous)
The impact of sex and contraceptive therapy on the plasma and intracellular pharmacokinetics of zidovudine. [2006.09.11]
OBJECTIVES: Zidovudine remains part of combination antiretroviral therapy. Pharmacological studies rely on quantitation of active triphosphates in peripheral blood mononuclear cells. This study evaluated the impact of female sex and contraceptive therapy on zidovudine plasma and intracellular pharmacokinetics and the impact of contraceptive therapy on HIV viral load... CONCLUSIONS: Using an optimized pharmacokinetic design, this study indicated men exhibit significantly higher zidovudine-monophosphate and zidovudine-triphosphate exposure following zidovudine oral administration, having implications for drug toxicity and overall tolerance of zidovudine therapy. The lack of an effect of contraceptive therapy on zidovudine pharmacokinetics is surprising in light of previous pharmacokinetic studies for drugs eliminated primarily through glucuronidation. Contraceptive therapy had no effect on plasma or cervical viral load, results consistent with previous findings.
Oral zidovudine during labor to prevent perinatal HIV transmission, Bangkok: tolerance and zidovudine concentration in cord blood. Bangkok Collaborative Perinatal HIV Transmission Study Group. [2000.03.31]
OBJECTIVES: To evaluate tolerance for the oral administration of zidovudine (ZDV) during labor and measure the resulting ZDV concentrations in umbilical cord blood. DESIGN: A cross-sectional study of women in a placebo-controlled trial of short-course ZDV (twice a day from 36 weeks' gestation until labor and every 3 h during labor) to prevent perinatal HIV transmission in Bangkok... CONCLUSION: Oral intrapartum ZDV was feasible and well tolerated. Most ZDV concentrations in the cord blood after oral dosing during labor were at therapeutic concentrations but were lower than those reported after continuous intravenous administration. Although concentrations were not associated with perinatal transmission, these data do not exclude the possibility that intrapartum and neonatal chemoprophylaxis is effective.
Efficacy of zidovudine and human immunodeficiency virus (HIV) hyperimmune immunoglobulin for reducing perinatal HIV transmission from HIV-infected women with advanced disease: results of Pediatric AIDS Clinical Trials Group protocol 185. [1999.03]
Pediatric AIDS Clinical Trials Group protocol 185 evaluated whether zidovudine combined with human immunodeficiency virus (HIV) hyperimmune immunoglobulin (HIVIG) infusions administered monthly during pregnancy and to the neonate at birth would significantly lower perinatal HIV transmission compared with treatment with zidovudine and intravenous immunoglobulin (IVIG) without HIV antibody.
Methadone effects on zidovudine disposition (AIDS Clinical Trials Group 262). [1998.08.15]
Large numbers of injection drug users (IDUs) are infected with HIV and receive both methadone and zidovudine (ZDV) therapy. Pharmacokinetic interactions between these agents may effect drug efficacy, toxicity, and compliance.Increased toxicity surveillance and possibly reduction in ZDV dose are indicated when these two agents are given concomitantly.
Oral and intravenous zidovudine pharmacokinetics: the effect of granulocyte-macrophage colony stimulating factor. [1995.09]
Combination therapy with zidovudine and recombinant human granulocyte-macrophage colony stimulating factor (rHu GM-CSF) may be warranted, owing to the bone marrow suppressive effects of zidovudine. A study of 16 patients, 8 of whom had acquired immune deficiency syndrome (AIDS) and 8 of whom were infected with human immunodeficiency virus (HIV) but were asymptomatic, was conducted...
Clinical Trials Related to Retrovir I.V. (Zidovudine Intravenous)
Zidovudine, Interferon Alfa-2b, and PEG-Interferon Alfa-2b in Treating Patients With Human T-Cell Lymphotropic Virus Type 1-Associated Adult T-Cell Leukemia/Lymphoma [Terminated]
RATIONALE: Human T-cell lymphotropic virus type 1 can cause cancer. Zidovudine is an
antiviral drug that acts against the human T-cell lymphotropic virus type 1. Giving
zidovudine, interferon alfa-2b, and PEG-interferon alfa-2b together may stimulate the immune
system and slow down or keep the cancer cell from growing.
PURPOSE: This clinical trial is studying how well giving zidovudine together with interferon
alfa-2b and PEG-interferon alfa-2b works in treating patients with human T-cell lymphotropic
virus type 1-associated adult T-cell leukemia/lymphoma.
Safety of Reduced Dose Zidovudine (AZT) Compared With Standard Dose AZT in Antiretroviral-na�ve HIV-infected Patients [Recruiting]
The primary objective of the study is to compare the tolerance and safety between a low-dose
Zidovudine (AZT) containing regimen (200 mg BID) and a standard dosage (300 mg BID) in HIV
patients initiating a first line antiretroviral therapy. The investigators expect that the
low-dose regimen will show improved tolerability and safety compared to the standard dosage,
with significant reduction in number of patients experiencing a new grade 1 to 4 anaemia or
increasing their anaemia grade during the first 6 months of treatment.
The secondary objectives of the study is to compare the efficacy of the two dosing regimen,
as measured by classical clinical and biological markers: the number of new AIDS defining
illness, the mortality rate, the proportion of patients achieving virological success and
the mean CD4 cell count increase from baseline.
Bioequivalence Study of Pediatric Formulations to Treat HIV Infection [Active, not recruiting]
The purpose of the study is to determine the bioavailability/bioequivalence of two pediatric
formulations (tablet and reconstitutable suspension) of lamivudine/zidovudine/ nevirapine in
comparison to an innovator product. Establishing the bioequivalence of a newly developed
age-appropriate fixed dose combination of lamivudine/zidovudine/ nevirapine as an oral
dispersible tablet or a reconstitutable suspension for children is invaluable for future
product registration and availability of the products to children, thus filling the void in
pediatric HIV/AIDS therapy.
A Study of Retrovir in the Treatment of Psoriasis in HIV-Positive Patients [Completed]
To evaluate the feasibility of Retrovir (AZT) in the treatment of psoriasis in HIV antibody
positive patients. Retrovir has been shown to be effective in the treatment of AIDS. In
addition, the administration of AZT appears to have induced a remission of psoriasis in one
case study. In light of AZT's antiviral activity and potential effectiveness as an agent for
the treatment of psoriasis, this would be the most likely treatment for HIV positive,
psoriatic patients whose disease progresses quickly.
Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure [Completed]
Page last updated: 2007-02-12