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Concrete ethical standards for human research are clearly stipulated in both international and national codes of ethics, and are meant to protect human subjects, especially the most vulnerable. A recent clinical study conducted from 1994 to 1997 by Dr. Thomas C, Quinn, M.D. has fueled the debate raging in the scientific community regarding the ethics of clinical AIDS research in developing countries. Quinn's conducted a community-based, randomized, controlled study of 15,127 rural Ugandans to determine whether intermittent antibiotic treatment to reduce the prevalence of other sexually transmitted diseases would also reduce the rate of HIV transmission. Subsequently, the study identified 415 couples in which one partner was HIV positive and one was initially HIV negative and followed them prospectively for up to 30 months. Researchers were not permitted to inform the seronegative partner of the HIV status of the other partner. As a result, 90 of the initially HIV negative partners (21.7%) seroconverted during a follow-up period of 30 months. To allow for research studies in developing countries that are not permitted in the United States appears to make the Third World equivalent to a 'research sweat shop'. Developing nations offer easy access to patients, reduced costs, and less stringent regulations. This appears to create a double standard for medical research that is both ethically and humanly unacceptable, especially when other viable option exist. To allow relativism to seep into the international and national ethical standards will open the door to an idea that condones the possible abuse of those least able to protect themselves. Researchers have an ethical responsibility to uphold the integrity of these ethical standards. Failure to do so today may have a devastating impact on humanity in the future.
Med Sci Monit 2002 Sep
PMID:AIDS research in developing countries: do the ends justify the means? 1221 51

This paper reviews reproductive health-related legislation introduced and acted on in the 50 states of the US to August 31, 1992. California, Illinois, Massachusetts, Michigan, New Jersey, New York, Ohio, Pennsylvania, and Wisconsin had not, however, closed session as of the end of August, and the legislatures of Arkansas, Montana, Nevada, North Dakota, Oregon, and Texas did not convene in 1992. Subjects addressed include abortion, family planning services, sex education, teenage pregnancy, adoption, infertility, maternal and infant care, and sexually transmitted diseases/AIDS. Specifically under abortion, the paper considers the status of legal abortion, parental consent, informed consent and waiting periods, and clinic licensing and harassment of providers. Subtopics on family planning, NORPLANT, welfare reform, sex education, and teen pregnancy prevention are then presented, followed by a review of current issues in adoption, infertility, and surrogacy contracts. Prenatal and infant care, perinatal drug and alcohol abuse, and family/medical leave are also covered. Closing section address HIV testing, consent, and notification; education and prevention strategies; treatment, insurance coverage, and discrimination.
State Reprod Health Monit 1992 Sep
PMID:Overview. 1228 4

Adolescent pregnancy prevention programs in the US pertain to sex education about reproduction, condom availability in schools, and outreach. This review of state actions on reproductive health policy in 1995 shows that, of the more than 100 bills introduced in 41 states, 16 bills were enacted. Some states eliminated condom and sex education programs in schools. 64 bills related to sexuality education in 30 states. 75% of these bills aimed to eliminate or restrict the scope of comprehensive sexuality education. The five laws enacted were identified as receiving a comprehensive analysis in the "State Reproductive Health Monitor," Vol.6, No.2, June 1995. The conservative states of North Carolina, Oklahoma, and Texas enacted new laws, which eliminated the teacher requirement for providing pregnancy prevention and disease education. These states retained education about sexually transmitted diseases and sexuality education. North Carolina and Texas granted parents the right to remove students from these classes, and schools must inform parents of their rights. Oklahoma required parental consent for attendance in these classes. Most proposed legislation about condom distribution in schools attempts to prohibit condom access. In 1995, there were 11 measures on prohibiting condom access proposed in 9 states, but none were enacted. Massachusetts is the only state where the State Board of Education policy recommends that schools consider condom availability as part of their HIV/AIDS prevention education efforts. This action was upheld in the Massachusetts Supreme Court. Four bills, out of 50 bills introduced in 1995, were enacted on unintended teenage pregnancy prevention issues. Opponents to sexuality education tend to promote abstinence-only education and an emphasis on the immorality and negative consequences of sexual intercourse. Opponents also tend to remove information from the curricula on pregnancy prevention and disease prevention on the grounds that it promotes sexual activity. School boards in Georgia must approve textbooks. About 22 states require some form of sexuality education. 40 states require education about sexually transmitted diseases and AIDS. There has been no new legal activity in the last three years among states to promote comprehensive education. Over 400 schools have condom availability programs. A more complete description of these programs is available from the "State Reproductive Health Monitor," Vol.6, No.3, September 1995.
State Reprod Health Monit 1995 Dec
PMID:Tracking the trends. Year-end review of state actions on reproductive health policy. Teenage pregnancy prevention. 1229 Dec 88

The fourth and final issue of The Alan Guttmacher Institute's 1992 State Reproductive Health Monitor: Legislation Proposals and Actions chronicles and summarized reproductive health-related legislation introduced and acted on in the 50 states in 1992, covering abortion, family planning services, sex education, teenage pregnancy, adoption, infertility, maternal and infant care, and sexually transmitted diseases/AIDS. Arkansas, Montana, Nevada, North Dakota, Oregon, and Texas did not convene. Abortion legislation involved parental consent/notice, informed consent and waiting periods, funding, abortion/reproductive rights, abortion bans, RU-486, clinic harassment, insurance coverage, reporting requirements, fetal research/remains, postviability abortion, sex selection, clinic licensing, spousal notification, conscience clauses, counseling and referrals, feticide, and proposals for promoting "alternatives to abortion." Family planning services, sex education, teenage pregnancy, Norplant welfare reform, infertility services, surrogacy contracts, perinatal drug and alcohol abuse and family and medical leave was also covered as was HIV testing, consent, and notification, education and prevention strategies, treatment, insurance coverage, and discrimination.
State Reprod Health Monit 1992 Dec
PMID:Overview. 1231 63

As more and more schools in the US have begun to establish programs to distribute condoms, opposition to this service has expanded beyond the arena of local hearings to the introduction of legislation to ban the practice in a number of states. During 1995, 11 measures were introduced, of which five would bar access to contraceptives, five would require parental consent, and one would prohibit the dispensing of longterm methods such as Norplant. None of these measures were enacted, and only two remain pending. Some of the proposed measures contained additional prohibitions, such as including inmates at state facilities, banning referrals for abortion without parental permission, and extending the scope of the restrictions beyond school-based services to include all minors. In all but six states, condom distribution in schools remains uncharted legal territory. 420 schools in 41 states currently provide condoms upon request. Only Massachusetts, however, has a Board of Education policy (which was upheld by the State Supreme Court) which encourages condom distribution in order to curtail HIV transmission. Opponents argue that condom distribution encourages sexual activity and usurps parental authority. Proponents point to the responsibility of the schools to perform public health functions.
State Reprod Health Monit 1995 Sep
PMID:Without much success, state legislators take aim at school condom programs. 1234 46

Complex drug interactions involving antiretroviral agents and drugs for the management of opportunistic infections demand the monitoring of plasma drug concentrations to prevent treatment failure. The high occurrence of tuberculosis in HIV-infected subjects makes the management of HIV treatment complex. Rifampicin, a potent inducer of the cytochrome P 450 metabolic pathway, is a very active antituberculosis drug that accelerates the metabolism of protease inhibitors. Regimens containing efavirenz, a non-nucleoside reverse transcription inhibitor, could be an alternative, but efavirenz plasma concentrations may be altered after the coadministration of rifampicin. Efavirenz is also a cytochrome P 450 inducer and may alter rifampicin plasma levels. Due to the increasing need to monitor plasma concentrations in HIV patients with tuberculosis, a high-performance liquid chromatographic (HPLC) method has been developed to measure rifampicin and efavirenz at the same time in a small amount of sample. This HPLC method is highly sensitive and precise, suitable for pharmacokinetic studies or routine clinical monitoring of rifampicin and efavirenz simultaneously in HIV patients with tuberculosis.
Ther Drug Monit 2002 Oct
PMID:Simultaneous determination of rifampicin and efavirenz in plasma. 1235 41

The factors that trigger the clinical onset of HIV-1-associated progressive encephalopathy (PE) in children remain unknown. HIV-1 invades the central nervous system (CNS) from the very beginning of infection, but the timeframe for PE development is variable. It has recently been suggested that increased traffic into the brain of HIV-1-infected or activated monocytes arising directly from the bone marrow may be the first step to clinical onset of adult HIV encephalopathy. The determining factor for this enhanced recruitment of blood monocytes into the CNS in adults has been postulated to be increased HIV-1 replication. However, children usually exhibit high levels of viral load beginning in the first months of life, even under very aggressive antiretroviral therapy. PE in children represents a unique form of CNS involvement of HIV, much more common, early, and devastating for children than for adults, representing in fact an independent cause of mortality. In the light of recent literature on this issue and our own in vitro and in vivo results the possible mechanisms implicated in the pathogenesis of PE are discussed. We propose that CD8+ T-lymphocytes would be the nexus for all the various aspects of the disease, namely the loss of control over HIV-1 replication, increased traffic of activated monocytes, the spread of infection to immune sanctuaries and finally the neurological emergence of PE. Possible new biologic markers
Med Sci Monit 2002 Oct
PMID:Reconstructing the course of HIV-1-associated progressive encephalopathy in children. 1239 35

The construction and isolation of recombinants of vaccinia virus (IHD-J strain), bearing on their outer membrane a chimeric protein consisting of the cytoplasmic and transmembrane domains of vaccinia B5R protein and the external domain of HIV envelope, has been previously described by us. The present study aimed to investigate the potential use of such recombinants as a vaccine, following inactivation of their infectivity by ultraviolet (UV) irradiation. The minimal dose of UV irradiation, required for the complete inactivation of the infectivity of these recombinants, was determined. Injections of rabbits with the irradiated noninfectious recombinant viruses successfully induced specific antibodies against the HIV envelope antigen, in addition to those against the poxvirus.
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PMID:Ultraviolet-irradiated vaccinia virus recombinants, exposing HIV-envelope on their outer membrane, induce antibodies against this antigen in rabbits. 1247 96

The authors describe the development of a population pharmacokinetic model using NONMEM for itraconazole and its active metabolite hydroxyitraconazole in a Thai cohort of HIV-infected patients who were using itraconazole as an addition to their antiretroviral therapy. The data were best described with an open two-compartment model for both itraconazole and hydroxyitraconazole. The model adequately described the data and provided population pharmacokinetic parameters which were not different from those described for other populations. The authors found that concomitant use of co-trimoxazole leads to a reduced formation rate (-51%) of hydroxyitraconazole.
Ther Drug Monit 2003 Apr
PMID:Population pharmacokinetics of itraconazole in Thai HIV-1-infected persons. 1265 19

The objective of this study was to investigate if sildenafil influences the pharmacokinetics of nelfinavir. Five HIV-infected patients on steady-state nelfinavir-containing therapy were subject to pharmacokinetic sampling for nelfinavir concentration twice: without sildenafil and with sildenafil 25 mg as a single dose. There were no differences in the AUC, T(max), or C(max) of nelfinavir. In a similar design, two patients on indinavir and two patients on ritonavir combined with saquinavir were studied. In accordance with the literature, neither of these two treatments was affected. It is concluded that nelfinavir pharmacokinetics were unaffected by concomitant intake of a single dose of sildenafil.
Ther Drug Monit 2003 Apr
PMID:Sildenafil does not alter nelfinavir pharmacokinetics. 1265 21


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