Double-blind placebo-controlled trial of oral dehydroepiandrosterone in patients with advanced HIV disease.

OBJECTIVE: Plasma levels of dehydroepiandrosterone sulphate (DHEA-S) decrease with the progression of HIV disease. Here, we report on the efficacy and safety of the oral administration of DHEA as replacement therapy, in patients with advanced HIV disease, in a trial that was primarily aimed at assessing quality of life. DESIGN: The trial was randomized and double-blind. Thirty-two patients were allocated to either DHEA 50 mg per day for 4 months (n = 14) or a matching placebo (n = 18). Clinical data, virological and immunological surrogate markers of HIV infection, plasma levels of DHEA-S and the Medical Outcomes Study HIV Health Survey (MOS-HIV) quality of life scale were recorded every month. RESULTS: The mean age of the patients was 40 +/- 11 years. The mean CD4 cell count at baseline was 32.5 +/- 32.4 x 10(6)/l. The mean DHEA-S plasma level at baseline was 5.23 +/- 0.76 micromol/l. No side-effects related to DHEA occurred during the study. A statistically significant increase in the levels of DHEA-S was observed in the treated group throughout the study (P < 0.01). A significant improvement in the Mental Health and Health Distress dimension of MOS-HIV was observed in the DHEA treated group; P = 0.001 and 0.004, respectively. No change in CD4 cell counts was seen during follow-up. CONCLUSIONS: The administration of DHEA in patients with advanced HIV infection results in improved mental function scores as assessed by the MOS-HIV quality of life scale.

Discrepant responses to triple combination antiretroviral therapy in advanced HIV disease.

OBJECTIVES: To determine the clinical, virological and immunological outcome in a cohort of unselected patients receiving triple combination therapy for more than 1 year. METHODS: Prospective follow-up of a cohort of 162 unselected, protease inhibitor-naive, antiretroviral-experienced patients with advanced HIV disease, treated with indinavir combined with two nucleoside analogues. RESULTS: The mean CD4 cell count and plasma HIV RNA level in the study group at baseline were 69+/-5 x 10(6)/l and 4.75+/-0.07 log10 copies/ml, respectively. Five per cent of patients died prematurely or were lost to follow-up. Fifty-seven per cent of patients responded to therapy, as assessed by a sustained increase in CD4 cell counts above 50 x 10(6)/l and a decrease in plasma HIV RNA greater than 1 log10 copies/ml, throughout 12.1 months of follow-up. Seventeen per cent of patients were immunological and virological non-responders. Twenty-one per cent of patients exhibited discrepant virological and immunological responses to treatment, of whom one-half failed to exhibit significant increases in CD4 cells despite a virological response to therapy and one-half exhibited increased CD4 cell counts in the absence of significant decrease in plasma viral load. The incidence of AIDS-defining events in the latter group of patients was similar to that of responder patients, whereas their incidence was higher in patients who failed to exhibit a virological and immunological response and those who failed to increase CD4 cells despite a significant decrease in viral load. CONCLUSION: Our observations of discrepant immunological and virological responses to treatment raise the issue of the significance of persistent elevated levels of plasma HIV RNA and of the relevance of measurements of plasma viral load for assessing the efficacy of antiretroviral therapy in patients whose CD4 cell counts increase despite the absence of significant decrease in plasma HIV viral load.

[Strategies for the prevention of human immunodeficiency virus infection]. / Stratégies de prévention de l'infection par le virus de l'immunodéficience humaine.

The prevention of AIDS can no longer rely solely on the wide availability of facts regarding the modes of contamination and the means of protection. Although almost everyone is now properly informed, and many are fully aware of the issues involved, still the epidemics keeps on developing. Therefore, time has come to recognize that new approaches have to be found. For example, we must take into account the psychic, social and cultural elements that define human sexuality. Putting the stress on changing someone's behaviours can induce a negative reaction if the injunction applied are deemed oppressive. Physicians must first of all be able to determine the type of prevention best suited to the particular situation of the patient that implies the setting up of a relationship based on mutual trust and listening. Counselling methods are an integral part of the health education strategies that can be applied by physicians.

[Medical interns and AIDS: perceptions and attitudes in 3 French regions]. / Les internes en médecine face au Sida: perceptions et attitudes dans 3 régions françaises.

This study has been conducted to clarify certain issues regarding residency training with regard to acquired immunodeficiency syndrome (AIDS). The objective was to evaluate resident physicians' experiences in, and attitudes toward, the care of persons with AIDS in France. The design was a cross sectional study, using a self administered mailed questionnaire to 627 residents in 3 French areas: Ile-de-France, Nord-Pas de Calais and Province-Côte d'Azur, with a follow up of non responders. The subjects of this study were a random sample of residents in the second year of specialty medicine or family medicine residencies (biological residents, surgeons, public health residents and research residents were excluded). The response rate was 56%. More than half of residents indicated that their training was deficient in AIDS ambulatory care and less of 40% felt competent to provide usual and primary care for AIDS patients. The social and psychosocial aspect of care seems to be the greatest difficulties for them. About the half of residents reported at least one needle stock contaminated by a patient's blood. Needle stick injuries from patients known to have HIV infection were reported by 8% of them. About 25% expressed great concern about the professional risk of HIV contamination and 24% indicated it is dangerous to provide care for AIDS patients. It appears that an important component of future education in medical residency programs should emphasize strategies to address social and psychosocial issues in the medical care of AIDS patients and to decrease the risk of needle stick injuries.

Residents' experiences in, and attitudes toward, the care of persons with AIDS in Canada, France, and the United States.

OBJECTIVE: To evaluate resident physicians' experiences in, and attitudes toward, the care of persons with the acquired immunodeficiency syndrome (AIDS) in Canada, France, and the United States. DESIGN: Cross-sectional survey, using a self-administered, mailed questionnaire to residents in 10 American states, three French regions, and all 10 Canadian provinces, with follow-up surveys of nonresponders in France and the United States. SUBJECTS: Systematic samples of residents in the last year of internal medicine or family medicine residencies prior to subspecialization or entry into medical practice. RESULTS: While the majority of residents had provided inpatient and outpatient care to persons with AIDS, most believed that their training in ambulatory care of persons with AIDS had been deficient. The rate of blood-contaminated needle-sticks from human immunodeficiency virus-infected patients ranged from 4% for internal medicine residents in Canada to 14% in the United States (P less than .05). The majority recognized an ethical obligation to treat AIDS, but 4% in France, 14% in Canada, and 23% in the United States indicated that they would not care for persons with AIDS if they had a choice (P less than .001). A substantial minority of US physicians reported that a patient of theirs had been refused care by a medical specialist (19%) or a surgeon (39%), but less than 10% of French physicians reported such refusals (P less than .001). CONCLUSION: Concerns about caring for AIDS patients were common and many physicians reported that patients were refused care. While most residents acknowledged an obligation to treat human immunodeficiency virus infection, many did not, and viewpoints varied considerably across the countries studied. The lower level of reluctance to treat AIDS patients in France and Canada makes it clear that the higher rate in the United States is far from optimal and needs to be addressed.